The intended use:

This product is applicable to DICOM 3.0 CT images. AI algorithm is used to automatically identify coronary artery stenosis, chest fracture and suspected positive cases of ICH to help trained clinician achieve workflow triage. This product uses AI algorithm to complete imaging abnormality marking of chest fracture automatically.

This product has coronary artery stenosis, fracture, ICH modules for users to choose.

The results of this product are intended to be used with other patient information and to assist in dividing/prioritizing of medical images based on the doctor's professional judgment. The notified clinician is responsible for viewing all images according to the nursing standard.

 

The performance:

The performance of the device can reach the following indicators.

For Fracture triage module, the sensitivity is ≥80% and the specificity is ≥80%.

For ICH triage module, the sensitivity is ≥85% and the specificity is ≥85%.

For Stenosis triage module, the sensitivity is ≥80% and the specificity is ≥70%.

The safety and performance of Computer Aided Rapid Triage Software InferRead® CT Rapid Triage are acceptable.

 

The Warning information and precautions:

Warning information

a) Warning: Software installation/upgrade/uninstallation must be performed by Infervision Technology personnel or by relevant technicians approved by Infervision Technology to avoid problems such as improper operation of software, delay of treatment due to user failure to use software normally.

b) Warning: The Company provides user operation training service. Operators or users shall receive necessary training before use of equipment to avoid misdiagnosis/delay triage.

c) Caution: If 3D reconstruction fails, please report to Infervision in time.

d) Caution: If the 3D reconstruction result cannot be obtained, please contact Infervision in time.  

e) Caution: Once the CT scan parameters specified by this product are exceeded, the algorithm may not work normally and the prediction results may be abnormal. The user must ensure that the input CT image is within the scan parameter requirements to avoid abnormal false positive or false negative predictions.

f) Caution: The accuracy of this product triage will be affected by image quality (caused by shooting level and patient's own cardiac condition), image scanning equipment and parameters. The result is only used as a reference for clinician's triage and cannot be used for triage alone. The clinician shall make comprehensive diagnosis according to the patient's medical history, symptoms and clinical examination results to avoid false negative/false positive caused by software results.

g) Caution: The fore-end measuring tool of this product is based on the image measurement of pixel points without any post-processing algorithm. The accuracy of the measurement depends on the correct use of the operator. If the measurement result is intended to assist clinical diagnosis, the user must confirm that the measuring tool is used correctly to reduce the measurement error.

h) Caution: Due to the accuracy limitation of the algorithm itself, the prompts may not be properly used for triage in all cases. The clinician to review the complete CT image series before making the final diagnosis, otherwise it may result in a false negative diagnosis conclusion.

i) Warning: This software assists manual triage. Please do not directly use the results of the software.

j) Warning: If image displaying and processing abnormalities, misdiagnosis/missed diagnosis are found, please report to Infervision timely.

k) Warning: If missing image critical data (e.g. Patient ID, Patient Name, etc.) is found in the system, please do not use it directly for triage patients.

l) Warning: Suspected coronary stenosis, suspected fracture and suspected ICH in the study list only provide the clinician with the order. Please do not directly use the results in the list. The final result depends on the doctor's judgment to avoid misdiagnosis/missed diagnosis.

m) Warning: This software does not support remote access function and is not allowed to connect to external network, so as to avoid patient information leakage and diagnostic data modification.

 

Precautions

1)  Precautions: Due to the limitations of the software, reconstruction may be unsuccessful under special circumstances, please do not use this software for diagnosis in this case.

2)  Precautions: Due to the limitations of the software, prediction may be successfully under special circumstances, please do not use this software to assist the triage function in this case.

3)  Precautions: The user shall install the authorized software to avoid data security damage, patient information disclosure, etc. If unauthorized software is installed, it shall be approved by the Company.

4)  Precautions: Before leaving, the user shall lock the screen computer or cancel the account number to avoid patient information disclosure or unauthorized operator operating software.

5)  Precautions: If PACS and CT device data are not received for a long time, check whether the PACS or CT device is working properly and check whether the DICOM label is correct.

6)  Precautions: This software database does not provide external access interface and cannot access the database.

7)  Precautions: In order to ensure the safe and stable operation of the server, please install antivirus software and firewall software that meet the requirements of the end user in advance on the service, and set the software reasonably to ensure the normal operation of these software.

8)  Precautions: To ensure the safe and stable operation of the server, please disable the serial port and parallel port if possible. After installation, please disable the external USB device.

9)  Precautions: After using the hospital server installed in this software, sensitive data will be stored in the server. Please confirm the security of data and have log records, and delete the personal data on the server (including hard disk) after the software is stopped. 

10)  Precautions: Users shall use servers, computers and other hardware equipment that meet electromagnetic compatibility (EMC) to use this software.

11)  Precautions: The operating environment of the product shall be checked during routine product maintenance.