(56 days)
The 2MP/3MP LCD Monitor (HMD2C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
This document is a 510(k) summary for the Hisense 2MP/3MP LCD Monitors (HMD2C21/HMD3C21). A 510(k) submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. This type of submission focuses on comparing the new device's characteristics to a predicate, rather than an independent study to define acceptance criteria and then demonstrate performance against those specific criteria using a test set and ground truth.
Therefore, the requested information cannot be fully provided in the typical format of an AI/ML device study. Instead, I will describe the comparisons made to establish substantial equivalence.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of formal acceptance criteria and device performance as typically seen in a diagnostic AI study, this document compares the technical specifications and intended use of the proposed devices (Hisense HMD2C21 and HMD3C21) against their predicate devices (BARCO Nio 2MP and Nio 3MP). The "acceptance criteria" here is effectively meeting comparable specifications to the predicate device, thereby demonstrating substantial equivalence.
Table 1: Comparison of Proposed Devices (Hisense HMD3C21/HMD2C21) to Predicate Devices (BARCO Nio 3MP/2MP)
| Feature | "Acceptance Criteria" (Predicate Device Performance) (Nio 3MP) | Proposed Device Performance (HMD3C21) | "Acceptance Criteria" (Predicate Device Performance) (Nio 2MP) | Proposed Device Performance (HMD2C21) | Conclusion on Equivalence |
|---|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | Same | Displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | Same | Substantially Equivalent |
| Panel Size | 21.3" | 21.2" | 21.3" | 21.3" | Substantially Equivalent (difference deemed non-critical) |
| Pixel Pitch | 0.2115 mm | 0.21075 mm | 0.27 mm | 0.27 mm | Substantially Equivalent (proposed device is slightly better) |
| Brightness (typ.) | 800 cd/m² | 900 cd/m² | 800 cd/m² | 770 cd/m² | Substantially Equivalent (difference deemed non-critical) |
| Contrast Ratio (typ.) | 1400:1 | 1400:1 | 1400:1 | 1100:1 | Substantially Equivalent (difference deemed non-critical) |
| Native Resolution | 2048 x 1536 | 2048 x 1536 | 1600 x 1200 | 1600 x 1200 | Substantially Equivalent |
| Power Capacity |
§ 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).