(15 days)
The G52SP+/G52S+ 5MP Grayscale LCD Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
The G52SP+/G52S+ 5MP Grayscale LCD display is a display system for medical viewing, with high resolution 2560 x 2048, 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 anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
The provided document is a 510(k) summary for a medical display, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device or algorithm is not present in this document.
This document describes a medical display (G52SP+/G52S+ 5MP Grayscale LCD Display) and argues for its substantial equivalence to a predicate device (Barcoview, Nio 5MP-21") based on technical specifications and intended use. It is a regulatory submission for market clearance, not a performance study.
However, I can extract the following information that is somewhat relevant to the request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in the typical sense of a performance study with quantitative thresholds for diagnostic accuracy. Instead, it compares the proposed device's specifications to those of a predicate device to argue for "substantial equivalence." The "performance" refers to technical specifications rather than clinical performance.
| Comparison Item (ID) | Proposed Device (G52SP+/G52S+) Performance | Predicate Device (Nio 5MP-21) Performance | Discussion of Difference & Substantial Equivalence Claim |
|---|---|---|---|
| Intended Use | Displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. | Displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. | Same; SE not affected. |
| Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display | Same; SE not affected. |
| Pixel Pitch | 0.165 mm | 0.165 mm | Same; SE not affected. |
| Native Resolutions | 2560×2048 | 2560×2048 | Same; SE not affected. |
| Brightness | 1200 cd/m² | 700 cd/m² | Proposed device brightness is higher, stated as "better than" the predicate, thus SE not affected. |
| Contrast Ratio | 1200:1 | 800:1 | Proposed device contrast ratio is higher, stated as "better than" the predicate, thus SE not affected. |
| Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) | Same; SE not affected. |
| Active Display Size | 422mm x338mm(HxV) | 422mm x338mm(HxV) | Same; SE not affected. |
| Dimensions | Varied (e.g., 398.5mm (W) x 483.0mm (H) x 70.8mm (D) without Stand) | Varied (e.g., 382mm x 488mm x 114mm without Stand) | Comparable; SE not affected. |
| Operating Temperature | 0°C ~ 40°C | 0°C ~ 40°C | Same; SE not affected. |
| Transport/Storage Temperature | -20°C ~ 60°C | -20°C ~ 60°C | Same; SE not affected. |
| Operating Relative Humidity | 15% ~85% | 8% ~80%(non-condensing) | Comparable; SE not affected. |
| Transport/Storage Relative Humidity | 10% ~90% | 5% ~95% | Comparable; SE not affected. |
| 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).