(50 days)
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage and digital processing of medical images. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.
Picture archiving and communication system (PACS)/ QXLink
This is a 510(k) clearance letter for the QXLink PACS device. As such, it primarily focuses on establishing "substantial equivalence" to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for the QXLink device itself.
Therefore, the requested information about acceptance criteria and a study proving the device meets them is not available in the provided document. This document confirms the regulatory clearance based on substantial equivalence, but it does not contain the technical performance study details you're asking for.
Here's why and what can be inferred:
- Acceptance Criteria and Reported Device Performance: Not provided in this regulatory letter. Substantial equivalence typically means the new device performs at least as well as the predicate device, but specific quantitative metrics are not detailed here.
- Sample size, data provenance, ground truth, adjudication, MRMC, standalone, training set details: These are all elements of a detailed performance study, which would be contained in a separate submission report to the FDA, not in the clearance letter itself.
To obtain the information you're looking for, you would generally need to refer to the original 510(k) submission documentation, which is often much more extensive than the clearance letter.
§ 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).