(55 days)
The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.
The MD205MG-1 cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
Medical Display, MD205MG-1 is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided text is a 510(k) summary for a medical display device, the NEC Medical Display, MD205MG-1. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial or AI algorithm validation study would.
Therefore, much of the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details) is not applicable or not present in this type of regulatory submission.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document describes a device (a medical display monitor) and its intended use, rather than a diagnostic algorithm or a device with specific performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to conformity with established standards for medical devices and displays, and "device performance" refers to its technical specifications matching the predicate device or meeting those standards.
| Acceptance Criteria / Standard | Reported Device Conformance / Specification |
|---|---|
| Intended Use | "displaying and viewing of digital image diagnosis including digital mammography system by trained physicians." |
| Resolution | 5 mega pixel (2560*2048) |
| Gamma grayscale | Adjustable |
| Standards Compliance | UL60601-1, EN60601-1-2, PAS-1054, DDN6868-57, ISO13406-2 |
| Compatibility | Must be used with NEC approved display cards |
| Safety | Does not contact with the patient, does not control any life-sustaining device |
| Interconnection | Designed for exclusive interconnection with IEC60601-1 certified equipment |
| Equivalence to Predicate | Substantially equivalent to MDM2010-5NC (K063269) for intended use, despite differences in panel, luminance, and scanning frequency. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a hardware conformity assessment, not an algorithmic performance study on a test dataset of images/patients.
- Data Provenance: Not applicable for an "algorithm test set." The device itself (the monitor) underwent testing against compliance standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" for a test set of medical cases/images in this context, as it's a display monitor. The compliance standards themselves form the basis of evaluation.
4. Adjudication method for the test set
- Not applicable. No adjudication method for medical cases is described.
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 hardware device (a display monitor), not an AI algorithm. Therefore, no MRMC study, AI assistance, or effect size is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device.
7. The type of ground truth used
- Not applicable in the context of clinical "ground truth" from pathology, expert consensus, or outcomes data. The "ground truth" for this device's evaluation is its adherence to technical specifications, safety standards (UL60601-1, EN60601-1-2, etc.), and functional equivalence to the predicate device.
8. The sample size for the training set
- Not applicable. This is a hardware display device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is a hardware display device, not an AI algorithm.
§ 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).