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510(k) Data Aggregation
(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 |
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