(44 days)
The 5MP (Mammo) LCD Monitor System™ is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
The 5MP (Mammo) LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying medical and mammography images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
The provided text is a 510(k) summary for the WIDE Corporation's 5MP (Mammo) LCD Monitor System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or clinical effectiveness.
The device described is a medical monitor system, not an AI-powered diagnostic tool. Therefore, many of the requested criteria (such as sample size for test sets, ground truth establishment, MRMC studies, standalone algorithm performance, and training set information) are not applicable or present in this type of document for a monitor.
Here's what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided text. The 510(k) summary focuses on demonstrating substantial equivalence in terms of technological characteristics and safety, not on specific performance criteria related to diagnostic accuracy (which would be relevant for an AI-powered device). The monitor's performance would be assessed against technical display standards, not clinical outcome metrics.
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/Not provided. This document describes a monitor, not an algorithm tested with a dataset of medical images.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth is not established for a monitor in the same way it would be for a diagnostic algorithm.
4. Adjudication method for the test set:
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. This is a monitor, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a monitor, not an algorithm.
7. The type of ground truth used:
- Not applicable/Not provided.
8. The sample size for the training set:
- Not applicable/Not provided. This is a monitor, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of what the document does provide:
- Device: 5MP (Mammo) LCD Monitor System™
- Intended Use: Displaying and viewing medical digital images for review and analysis by trained medical practitioners, specifically for digital mammography applications.
- Predicate Device: CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K041508)
- Regulatory Focus: Substantial equivalence regarding technological characteristics, safety, and compliance with voluntary and safety standards (e.g., UL, IEC, FCC, CE).
- Safety Assessment: Potential hazards classified as Minor.
- Conclusion: The FDA determined the device is substantially equivalent to the predicate device.
To answer your request comprehensively, you would need a different type of document, such as a clinical validation report, if the device were software or an AI algorithm, rather than a monitor.
§ 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).