(75 days)
Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
The provided text does not describe acceptance criteria for device performance or any study conducted to prove the device meets such criteria.
The document is a 510(k) summary for the Stentor PageView software, submitted to the FDA in 1999. Its primary purpose is to demonstrate substantial equivalence to previously cleared devices, not to present performance data against specific acceptance criteria.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria or Performance Data: The document states that the software was "designed, developed, tested and validated according to written procedures" and that "Extensive testing of the software package has been performed." However, it does not provide any specific quantitative performance metrics (e.g., accuracy, speed, uptime, image fidelity measures) that would constitute acceptance criteria, nor does it report the results of any such tests.
- Focus on Substantial Equivalence: The bulk of the "Safety and Effectiveness" section and the "Substantial Equivalence Chart" (Section 1.9) compare the PageView's features and technological characteristics to predicate devices (Mitra-Exhibit and PACScache). The conclusion is that differences have "no significant influence on safety or effectiveness," which is a regulatory argument for equivalence, not a detailed performance study.
- No Mention of Specific Study Design: There is no description of a study (retrospective/prospective, sample sizes, data provenance, expert roles, adjudication methods, MRMC studies, or standalone performance) that would be typically conducted to prove performance against specific criteria.
- Ground Truth: Since no performance study is described, there's no mention of how ground truth would be established for any test or training set.
- Training Set Information: There is no information about a training set, as the document does not describe the development or validation of an AI/ML algorithm that would typically require one. The software's function is described as converting DICOM images for display, not a diagnostic algorithm.
In summary, the provided text does not contain the information required to populate the requested table or answer the specific questions about acceptance criteria and performance studies because the document's intent is to establish substantial equivalence based on feature comparison, not to report on quantitative performance metrics.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.