(261 days)
The MW100 (Mammography) 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 MW100 (Mammography) LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor that connects to a hi-resolution graphic control board (not supplied by WIDE Corporation), that is installed into a PACS workstation. The MW100 (Mammography) LCD Monitor System consists LCD monitor. The computer, computer hardware, any workstation PACS software, monitor image calibration software (e.g. Lumical Software and graphic interface is supplied by the user and should be based upon WIDE Corporation recommendations as described in the MW-100 User Manual.
The provided text describes a medical device, the MW100 (Mammography) LCD Monitor System, and its acceptance for market. However, it does not contain the detailed information requested regarding specific acceptance criteria metrics, a study proving device performance against those criteria, sample sizes, expert qualifications, or ground truth methodologies.
The document is a 510(k) summary for a medical device submitted to the FDA, focusing on establishing substantial equivalence to a predicate device. This type of submission typically highlights that the new device is as safe and effective as a device already on the market, rather than presenting a performance study with detailed acceptance criteria and results.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states: "The Validation Test Plan was designed to evaluate all input functions, output functions, and that as required by the risk analysis, designated individuals performed all verification and validation activities on the WIDE MW-100 device. The results demonstrated that the predetermined acceptance criteria were met." However, it does not specify what those "predetermined acceptance criteria" were or report the explicit device performance against them in a table format with specific metrics (e.g., resolution, luminance uniformity, contrast ratio, etc.). It only vaguely mentions that "the requirements for monitors as outlined in AMLCD AAPM TG 18 & Specifications are provided in the 510(k)".
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document mentions "nonclinical testing" but does not describe a test set in the context of image data or patient studies. It refers to internal testing of the monitor system itself, not its performance in interpreting medical images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The device is a monitor, not an AI or diagnostic tool that requires ground truth established by experts for its performance evaluation in this context. The document explicitly states: "Diagnosis is not performed by the monitor but by Radiologists, Clinicians and referring Physicians." and "Note: The subject device does not include any automated or semi-automated process for the detection of nodules or other shapes."
4. Adjudication Method for the Test Set
Not applicable. As above, this monitor does not perform diagnostic tasks that would require a test set with adjudicated ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. No MRMC study is mentioned. This device is a display monitor, not an AI-assisted diagnostic tool for which an MRMC study would typically be conducted.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No. The device is a monitor. Its primary function is to display images for human interpretation, not to perform standalone algorithmic diagnostic tasks.
7. The Type of Ground Truth Used
Not applicable. For this device (a monitor), "ground truth" in the context of diagnostic accuracy for medical images is not relevant to its regulatory approval described here. The "ground truth" for the monitor itself would be its compliance with technical specifications (like those in AAPM TG 18), but these specific details are not provided in the summary.
8. The Sample Size for the Training Set
Not applicable. This device is a display monitor and does not involve AI or machine learning algorithms that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, no training set is involved.
In summary, the provided 510(k) summary focuses on demonstrating the substantial equivalence of an LCD monitor system to a predicate device based on its technical characteristics and intended use, rather than presenting a performance study with detailed clinical acceptance criteria and results. The document explicitly states that the monitor itself does not perform diagnosis or automated detection.
§ 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).