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WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use in viewing medical images and making geometric measurements on medical images over the world wide web.

WebPAX is an integrated software and hardware package capable of communicating and storing medical images. WebPAX provides users with capabilities relating to the transfer, display, and storage of medical images as well as the ability to make geometric measurement of features within the medical images. WebPAX is designed to be deployed over conventional TCP/IP networks and interacts with standard commercially-available computer platforms. WebPAX does not produce any original medical images have been received from DICOM compliant scanners and workstations.

Heart Imaging Technologies, LLC - 510(k) for WebPAX

Acceptance Criteria and Study Details:

This 510(k) pertains to WebPAX, a Picture Archiving and Communications System (PACS). The core functionality tested was its ability to perform geometric measurements on medical images, comparing it to a predicate device, the Siemens LEONARDO syngo Cardiology Workstation.

The acceptance criteria for the WebPAX device were based on demonstrating substantial equivalence to the predicate device in geometric measurements. The study aimed to show that there were no statistically significant differences between measurements made using WebPAX and those made using the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for the Test Set:

• Sample Size: The document states that "geometric measurements were made on the plurality of medical images in a plurality of identical locations within each of the images." While "plurality" indicates more than one, a specific number for the images or locations is not provided in this summary.
• Data Provenance: Medical images based on a plurality of imaging modalities were used. The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only states that the images were "received from DICOM compliant scanners and workstations."

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

The study described is a non-clinical, comparative performance study between two devices, not an evaluation of human performance or diagnostic accuracy that would typically require expert-established ground truth.

• No information is provided regarding experts or their qualifications for establishing ground truth as the study focused on device-to-device measurement comparison, not human interpretability or diagnosis.

4. Adjudication Method for the Test Set:

As the study compares geometric measurements between two systems and does not involve human interpretation or subjective assessments that would require adjudication for discrepancies, no adjudication method is mentioned or appears to be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical test comparing the geometric measurement capabilities of WebPAX to a predicate device. It does not involve human readers evaluating images with and without AI assistance (as WebPAX is a PACS, not an AI for image interpretation).

6. Standalone Performance Study:

• Yes, a standalone performance was done in the context of comparing its geometric measurement capabilities to a predicate device. The study directly evaluated the WebPAX system's ability to perform geometric measurements independently, then compared these measurements to those from the predicate device. The performance was "algorithm only" in the sense that the device's measurement function was tested, rather than its impact on human diagnostic accuracy.

7. Type of Ground Truth Used:

• The "ground truth" for the test was established by the measurements made by the predicate device. The study's objective was to demonstrate that WebPAX produced measurements that were not statistically significantly different from those of the legally marketed predicate device. This is a form of comparative ground truth against an established device.

8. Sample Size for the Training Set:

• This device is not described as involving machine learning or AI that would require a separate training set. The WebPAX system is a PACS for image communication, storage, viewing, and geometric measurement. Therefore, a training set is not applicable or mentioned.

9. How Ground Truth for the Training Set Was Established:

• As there is no mention of a training set for machine learning, this question is not applicable to the information provided.

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