FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Medical Display, L218TK is a 21.3" Color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for a medical display, the NEC MD21M 21.3" Diagnostic Imaging LCD monitor (Model L218TK). It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI algorithm would.

Instead, the "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device and meeting general performance expectations for a diagnostic display. The "study" proving it meets these is the comparison to the predicate device and the inherent design specifications of the display unit.

Here's the breakdown based on the provided text, recognizing the limitations of a 510(k) for a display device vs. an AI algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical display and not an AI algorithm, the "acceptance criteria" are not explicitly listed in a quantitative fashion that would typically be found in an AI performance study. Instead, the general acceptance criteria are implicit:

Intended Use Equivalence: The device's intended use must be substantially equivalent to the predicate device.
Technological Characteristics Equivalence: The device must share similar technological characteristics, or any differences must not raise new questions of safety or effectiveness.
Display Performance: The display must be capable of showing digital images for diagnosis by trained physicians, including specific resolution and adjustable gamma grayscale, as stated in the description.
Safety Standards: Compliance with relevant safety standards (e.g., IEC60601-1 for interconnection).

Acceptance Criteria (Implicit from 510(k) Purpose)	Reported Device Performance
Intended Use	Same as predicate device (displaying digital images for diagnosis by trained physicians)
Resolution	2 mega pixel (1600*1200)
Grayscale Adjustment	Adjustable gamma grayscale
Image Display Capability	Displays images for medical use (CT, MRI, HIS, PACS)
Safety & Effectiveness	Concluded to be substantially equivalent to predicate device; minor differences do not raise new questions of safety and effectiveness. Does not contact patient, does not control life-sustaining device.
Interconnection Safety	Designed for exclusive interconnection with IEC60601-1 certified equipment

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) for a display device. There isn't a "test set" of medical images or patient data in the way there would be for an AI algorithm. The evaluation is on the hardware's specifications and its equivalence to a predicate device.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth for medical image interpretation by experts is not established for a display monitor's 510(k). The regulatory body (FDA) reviews technical specifications and equivalence claims.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a new diagnostic method or AI on human reader performance, which is not relevant for a display screen's 510(k) submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a display monitor, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. For a display device, the "ground truth" would relate to its physical and performance specifications (e.g., luminance, contrast, resolution, color accuracy), which are verified through engineering testing and comparison to industry standards and the predicate device, not necessarily against clinical ground truth like pathology for an AI.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is a hardware display, not an AI algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

Regulation Number and Section

§ 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).