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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.

Study Information (Device K140108 - 3MP Color LCD Display)

This submission is for a medical display, not a diagnostic algorithm, so the concept of a "study" to prove performance against clinical ground truth or human reader performance is not applicable in the same way it would be for an AI-powered diagnostic device. Instead, the "study" is a technical comparison against a predicate device and adherence to relevant standards.

1. Sample size used for the test set and the data provenance: Not applicable. This is a hardware comparison based on technical specifications and compliance with standards. There is no "test set" of medical images or patient data in the context of diagnostic performance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for a display device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a display device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established technical specifications and performance of a legally marketed predicate device, and compliance with recognized safety and performance standards (e.g., 21 CFR 1020.33, IEC 60601-1, IEC 60601-1-2).
7. The sample size for the training set: Not applicable. There is no training set for a display device.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a technical and regulatory comparison against a predicate device (BARCO Nio Color 3MP LED) and adherence to recognized standards.

• Methodology: The manufacturer conducted a direct comparison of the proposed device's technical specifications and intended use against those of the predicate device. They also ensured compliance with relevant safety and performance standards.
• Key Findings:
  • Intended Use: The intended use is identical to the predicate device: "displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners."
  • Performance (Technical Specifications): Most technical parameters (Panel Size, Pixel Pitch, Native Resolutions, Brightness, Network Interface, Active Display Size, Operating/Storage Temperature ranges, Usability, Mode of Operation, Electrical/Mechanical Safety, EMC) were found to be either identical or comparable to the predicate.
  • Differences and Justification for Substantial Equivalence:
    • Contrast Ratio: The proposed device has a slightly higher contrast ratio (1400:1) than the predicate (1300:1), which the manufacturer argued is "better" and does not negatively affect safety and effectiveness.
    • Dimensions, Relative Humidity, Power Capacity, Input Voltage: While some numerical differences exist, the manufacturer states these are "comparable" or comply with relevant general safety standards (IEC 60601-1, IEC 60601-1-2), and thus do not affect safety or effectiveness.
• Conclusion: The manufacturer concluded that the C32SP+/C32S+ 3MP Color LCD display is substantially equivalent to the predicate device (BARCO Nio Color 3MP LED) with regard to safety and effectiveness, based on the comparative analysis and compliance with standards. The FDA subsequently cleared the device, confirming this substantial equivalence.

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