(301 days)
The AXIS-V 5MP Radiological Monochrome Medical Display is intended to be used to display and view digital images, including digital mammography, for review and analysis by trained medical practitioners.
The AXIS-V 5MP Monochrome Display is a diagnostic display.
The AXIS-V 5MP Monochrome Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.
The provided text is a 510(k) summary for a medical display device, the AXIS-V 5MP Monochrome Display. It does not contain information about acceptance criteria, study data, sample sizes, expert ground truth establishment, or any comparative effectiveness studies as requested in your prompt. This document serves as a regulatory submission for premarket notification, establishing substantial equivalence to existing devices rather than detailing performance study outcomes.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:
- Manufacturer and Contact Information: National Display Systems, LLC.
- Device Description: AXIS-V 5MP Monochrome Display, a high-resolution Liquid Crystal Display (LCD) for viewing medical images, including digital mammography.
- Intended Use: To display and view digital images for review and analysis by trained medical practitioners.
- Classification and Product Code: 21 CFR 892.2050/Procode 90LLZ (Picture archiving and communications system).
- Substantial Equivalence: Claimed against Coronis 5MP (Barco) K042221 and RadiForce G51 (Eizo Nanao) K042755.
- FDA Communication: A letter from the FDA acknowledging review of the 510(k) and determining substantial equivalence, allowing the device to be marketed under general controls.
To provide the information you're looking for, I would need a different document, such as a clinical study report, a detailed performance evaluation report, or a more comprehensive technical submission that outlines the testing and validation performed on the device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).