(55 days)
This Premarket Notification 510(k) is being filed to cover additions to the LINX™ Networking System with LINX™ Laser Imager (K900935) to include all capabilities that we are adding to meet market demands. The basic product concept remains - to connect various image input devices to one or more output devices. That basic concept has been expanded to meet market demands: new image source interfaces new control interfaces new network interfaces more output devices supported new data types managed image transfer mechanisms (some output devices may require handling in the transmission path to the output device to compensate for differences in devices)
The LINX™ Networking System is a system to connect various image input devices to one or more output devices. Additions to the system include new image source interfaces, new control interfaces, new network interfaces, support for more output devices, management of new data types, and image transfer mechanisms.
I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document you've supplied is a "SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)" for the "LINX™ Networking System." This document primarily focuses on demonstrating substantial equivalence to a predicate device by detailing expanded capabilities and updated features.
The text does not contain any information regarding:
- Acceptance criteria: There are no defined numerical thresholds or performance metrics.
- Study design or results: There is no mention of a formal clinical or technical study to evaluate the device's performance against specific criteria.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Instead, the document highlights expanded functionalities of the LINX™ Networking System compared to its predicate device, the LINX™ Networking System with LINX™ Laser Imager (K900935). This type of 510(k) submission generally relies on demonstrating that the new device does not raise new questions of safety and effectiveness, often by showing it performs as well as or better than the predicate device in terms of features and capabilities, rather than through a rigorous performance study with defined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions you've posed using the provided input.
§ 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.