(200 days)
The MGD 2621L device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MGD 2621L Medical Grayscale Display is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The MGD 2621L is a diagnostic display
The MGD 2621L device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
This document is a 510(k) summary for a medical grayscale display (MGD 2621L). It is for a display device, not an AI/ML algorithm or diagnostic device that makes clinical assessments. Therefore, the questions related to acceptance criteria for algorithm performance, sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth are not applicable.
The submission focuses on establishing substantial equivalence to a predicate device (Barco MGD 221) based on technical characteristics and intended use.
Here's the relevant information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics (sensitivity, specificity, etc.) for a diagnostic algorithm. Instead, it refers to substantial equivalence to a predicate device, which implies the device meets similar performance and safety standards.
| Characteristic | MGD 2621L (Proposed Device) | MGD 221 (Predicate Device, K000293) | Basis for Equivalence |
|---|---|---|---|
| Intended Use | Displaying and viewing digital images for review by trained medical practitioners (excluding digital mammography). | Displaying and viewing digital images for review by trained medical practitioners. | Similar (implicit) |
| Technological Characteristics | High resolution monitor with electronic capabilities for evaluation of high resolution medical images. | Diagnostic Display (Implicitly high resolution) | Similar (implicit) |
| Classification Name | System, image processing | System, image processing | Identical |
| Common/Usual Name | Medical flat panel grayscale display, monitor, display | Medical flat panel grayscale display, monitor, display | Similar |
| Proprietary Name | MGD 2621L | MGD 221 | Different (Model) |
| Classification Number | 21 CFR 892.2050 / Procode 90LLZ | 21 CFR 892.2050 / Procode 90LLZ | Identical |
2. Sample size used for the test set and the data provenance: Not applicable. This is a display device, not an algorithm being tested on a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a display device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This is a display device, not an AI/ML system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a display device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This is a display device.
8. The sample size for the training set: Not applicable. This is a display device.
9. How the ground truth for the training set was established: Not applicable. This is a 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).