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510(k) Data Aggregation
(30 days)
The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The C32SP+/C32S+ 3MP Color LCD Display is a display system for medical viewing, with high resolution 2048 x 1536, built-in brightness stabilization circuit 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 3MP Color LCD Display (C32SP+/C32S+) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the manner of an AI/human performance study. The document states that "All of parameters comply with 21CFR1020.33 and related IEC standards" and that the differences "do not affect the safety and effectiveness (SE)." This suggests that acceptance criteria would be defined by adherence to these standards and the comparison tables to the predicate device.
Given the nature of the document as a 510(k) submission for an LCD display, it focuses on technical specifications and substantial equivalence rather than clinical performance or human-in-the-loop studies typically associated with AI-powered devices. No information is present regarding:
- Sample sizes for test sets or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
Therefore, the requested information elements cannot be fully populated as they are not within the scope of this document.
However, based on the comparative tables provided, we can infer the acceptance criteria are alignment with the predicate device's specifications and compliance with relevant standards. The reported device performance is its technical specifications as listed.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly defined by the parameters of the predicate device and relevant standards (21CFR1020.33, IEC 60601-1, IEC 60601-1-2). The reported device performance is its specifications, which are presented as comparable or superior to the predicate.
| Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (C32SP+/C32S+) |
|---|---|
| Panel Size and Type: 21.3", TFT LCD display | 21.3", TFT LCD display |
| Pixel Pitch: 0.2115 mm | 0.2115 mm |
| Native Resolutions: 2048 x1536 | 2048 x1536 |
| Brightness: 1700 cd/m² (or comparable) | 1700 cd/m² |
| Contrast Ratio: 1300:1 (or comparable/better) | 1400:1 (considered better) |
| Network Interface: USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| Active Display Size: 433.2mm x324.9mm (or comparable) | 433.152mm x324.864mm |
| Operating Temperature: 0°C ~ 40°C | 0°C ~ 40°C |
| Transport/Storage Temperature: -20°C ~ 60°C | -20°C ~ 60°C |
| Operating Relative Humidity: 8% ~80% (non-condensing) | 15%~85% |
| Transport/Storage Relative Humidity: 5% ~95% | 10%~90% |
| Power Capacity: |
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(30 days)
The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The C32SP+/C32S+ 3MP Color LCD Display is a display system for medical viewing, with high resolution 2048 x 1536, built-in brightness stabilization circuit 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 describes a 510(k) submission for a 3MP Color LCD Display (C32SP+/C32S+) for medical viewing. The submission focuses on demonstrating substantial equivalence to a predicate device, the BARCO Nio Color 3MP LED.
Acceptance Criteria and Device Performance:
The "acceptance criteria" in this context are not explicitly stated as quantitative thresholds for a medical device's performance in a diagnostic study. Instead, for this type of device (a medical display), "acceptance criteria" are typically related to meeting established technical and safety standards, and demonstrating performance comparable to a cleared predicate device.
The document provides a comparison table (Table 2 General Comparison) that serves as the basis for demonstrating substantial equivalence. The "reported device performance" refers to the specifications of the proposed device.
| Comparison Item | Acceptance Criteria (based on predicate) | Reported Device Performance (Proposed Device C32SP+/C32S+) |
|---|---|---|
| Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display |
| Pixel Pitch | 0.2115 mm | 0.2115 mm |
| Available Cabinet Colors | Black | Black |
| Native Resolutions | 2048 x 1536 | 2048 x 1536 |
| Brightness | 1700 cd/m² | 1700 cd/m² |
| Contrast Ratio | 1300:1 | 1400:1 |
| Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| Active Display Size | 433.2mm x 324.9mm | 433.152mm x 324.864mm |
| Dimensions (without Stand) | 375mm x 488mm x 84mm | 369.0mm (W) x 482.6mm (H) x 63.6mm (D) |
| Operating Temperature | 0°C ~ 40°C | 0°C ~ 40°C |
| Transport/Storage Temperature | -20°C ~ 60°C | -20°C ~ 60°C |
| Operating Relative Humidity | 8% ~ 80% (non-condensing) | 15% ~ 85% |
| Transport/Storage Relative Humidity | 5% ~ 95% | 10% ~ 90% |
| Power Capacity |
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(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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