(119 days)
The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems products are intended to be used by healthcare professionals as a radiological image acquisition, storage, and routing system for remote acquisition and transmission of diagnostic images.
The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems
My apologies, but the provided text does not contain the specific information required to complete your request. The document is an FDA 510(k) clearance letter for a teleradiology system, detailing its substantial equivalence to previously marketed devices and its indications for use.
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number of experts for ground truth, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or details about training sets.
Therefore, I cannot extract the requested information from the given text.
§ 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.