(19 days)
The MFCD 1219 is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The MFCD 1219 TS is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
MFCD 1219 is a 19.0" color LCD display for medical viewing. Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.
MFCD 1219 TS is a 19.0" color LCD display for medical viewing, equipped with a 19.0" touchscreen panel. Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.
The provided document is a 510(k) summary for two medical flat panel displays, Barco MFCD 1219 and MFCD 1219 TS. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria and performance metrics typically found in efficacy studies for AI/ML devices or novel therapies.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of device performance in diagnosing or interpreting medical images.
Here's why and what the document does provide:
- Type of Device: These are display devices, not diagnostic algorithms. Their "performance" is related to image quality, resolution, and software functionality, not diagnostic accuracy.
- Regulatory Pathway: A 510(k) submission primarily establishes that a new device is "substantially equivalent" to a legally marketed predicate device. This means demonstrating that it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.
- Focus of the Document: The document outlines the technical specifications of the MFCD 1219 and MFCD 1219 TS, compares them to their predicate (MFCD 2320), and states that any differences do not affect safety or efficacy. It also describes the NioWatch software's functionality (setting display functions, test patterns, calibration).
Specifically, the requested information elements are not present because they are not typically part of a 510(k) for a display device:
- Table of acceptance criteria and reported device performance: This document doesn't define acceptance criteria for diagnostic performance or report such performance, as it's a display device.
- Sample size for test set and data provenance: Not applicable, as there's no diagnostic test set.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not done/applicable as it's not a diagnostic AI aide.
- Standalone performance study: Not done/applicable as it's a display, not a standalone diagnostic algorithm.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable, as no algorithm was trained for diagnostic purposes.
- How ground truth for training set was established: Not applicable.
In conclusion, the provided 510(k) summary is not designed to present information about diagnostic performance or the types of studies typically conducted for AI-based diagnostic tools. It focuses on technical equivalence to a predicate display 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).