Search Results

WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.

Due to special customer requirements based on the imaging modality and clinical focus, WebPAX can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. MPR is not intended for mammography use.

Not intended for diagnostic use on mobile devices.

WebPAX consists of a server, typically located in a hospital data center, and one or more client systems used by technicians and physicians. On the server side, WebPAX is a software-only solution that is installed on customer-supplied hardware, such as dedicated computer server or virtual machine. The server-side software communicates with other DICOM-compliant systems and with end-users via standard Intranet and/or Internet mechanisms. On the client side, technicians and physicians access the WebPAX server using standard Internet web browsers, such as Google Chrome and Internet explorer.

WebPAX provides users with the ability to manage, store, and interpret digital medical images, including the following application specific modules:

• . Echocardiography Workstation
• Cardiovascular MRI Workstation
• 3D Post Processing (Multi-Planar Reconstruction)

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

• Software Validation Report (Measurement Accuracy): The exact number of DICOM datasets/images used for testing measurement accuracy is not explicitly stated. It mentions "exact same DICOM dataset, image, and location(s) within the image" but not the total count.
• Reader Study Report (3D Post Processing): Six DICOM datasets representing typical clinical scenarios were used.
• Data Provenance: Not explicitly stated for either test. The "typical clinical scenarios" for the reader study imply a retrospective collection of real patient data, but the specific country of origin or whether it was retrospective/prospective is not provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Reader Study Report (3D Post Processing): Three board-certified physicians were used. Their qualification is stated as "who routinely read cardiovascular MRI studies."
• Software Validation Report (Measurement Accuracy): For measurement accuracy, the "ground truth" was established by measurements from the predicate device. No human experts were involved in establishing ground truth for this specific test; it was a direct device-to-device comparison.

3. Adjudication method for the test set:

• Reader Study Report (3D Post Processing): The text mentions that "All scores for WebPAX were at least a 1 (Excellent) or a 2 (Very good)." This suggests a scoring system, but it does not describe an explicit adjudication method (e.g., 2+1, 3+1 consensus). It implies an independent rating by each physician from which the reported scores were derived and compared.
• Software Validation Report (Measurement Accuracy): No adjudication method was applicable as the comparison was directly against the predicate device's output.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Yes, a multi-reader multi-case (MRMC) comparative effectiveness study was done for the 3D post-processing capability (referred to as a "Reader Study Report").
• Effect size of how much human readers improve with AI vs without AI assistance: This study was designed to demonstrate equivalence of the WebPAX's 3D post-processing capability to the predicate device, not to show improvement of human readers with AI assistance. The study assessed the performance of the device's output as judged by human readers, rather than the readers' performance with and without the device. The conclusion was "The performance of WebPAX was comparable to that of the predicate Siemens device."

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, the "Software Validation Report" for measurement accuracy serves as a standalone performance assessment. The WebPAX's measurement functionalities (Basic measurements, Echocardiography measurements, Cardiovascular MR measurements) were directly compared against the predicate device's measurements for the same DICOM data, without human interpretation in the loop for this specific test.

6. The type of ground truth used:

• Software Validation Report (Measurement Accuracy): The ground truth was effectively established by the measurements provided by the predicate device.
• Reader Study Report (3D Post Processing): The ground truth was expert consensus/evaluation (based on the physicians' scores of 'Excellent' or 'Very Good' for the WebPAX output). While not explicit "ground truth" in the sense of a definitive diagnosis, their assessment of the post-processing quality acted as the reference.

7. The sample size for the training set:

• The document does not provide information regarding the sample size for any training set. This device appears to be a PACS system with post-processing capabilities, not necessarily a deep learning AI model that requires a distinct "training set." The performance tests focused on verification, validation of measurements, and a reader study comparing it to a predicate.

8. How the ground truth for the training set was established:

• As no information on a training set is provided, this question cannot be answered from the document.

Ask a specific question about this device

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.

Ask a specific question about this device