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510(k) Data Aggregation
(90 days)
6MP Color LCD Monitor CL-S600
CL-S600 is intended to be used in displaying and viewing medical images for trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
30 inch Color LCD Monitor 3280 x 2080 (landscape)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
The provided text describes a 510(k) premarket notification for a medical LCD monitor (JVCKENWOOD 6MP Color LCD Monitor CL-S600). Since this is a submission for a display device, the acceptance criteria and study information provided are related to the technical performance of the monitor itself, rather than the performance of an AI algorithm or diagnostic accuracy.
Therefore, the response below will focus on the device's technical specifications and the tests conducted to demonstrate compliance and substantial equivalence to a predicate device, as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance test items in the guidance (which can be inferred as acceptance criteria for this type of device) and the methods used to verify compliance. The actual numerical performance results are not explicitly stated in this high-level summary but are implied to have met the relevant standards.
| Acceptance Criteria (Performance Test Item in Guidance) | Test Method(s) | Compliance / Reported Performance (Implied) |
|---|---|---|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital camera equipped with a macro lens. The MTF is calculated with the captured data. | Met (implied by conclusion) |
| b. Pixel defects (maximum counts, allowed defect types, and locations) | ISO 13406-2; IDMS 1.03, 7.6 DEFECTIVE PIXELS; Pixel defects are counted based on the ISO13406-2, 3.4.13 table 3. | Met (implied by conclusion) |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests; IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES. | Met (implied by conclusion) |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME; Rise and fall time constants at four grayscale intervals (0-100%, 5-95%, 10-90%, 40-60%) are provided by the panel manufacturer. | Met (implied by conclusion) |
| e. Luminance (maximum, minimum, achievable, and recommended) | $L_{min}$ and $L_{max}$ on the calibrated luminance are confirmed. | Met (implied by conclusion) |
| f. Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance Response; Luminance response for 256 levels are measured. | Met (implied by conclusion) |
| m. Color tracking (primary colors and color gamut) | Color scale: IDMS 1.03, 6. Gray- and Color-Scale Measurement; IDMS 1.03, 5.4 Color-Signal White; Color gamut volume: IDMS 1.03, 5.31 Volume-Color-Reproduction Capability. | Met (implied by conclusion) |
| n. Gray tracking (gray shades and white point) | AAPM-TG196 Gray Tracking; IEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscale chromaticity evaluation. | Met (implied by conclusion) |
Note: Items g, h, i, j, k, l are marked "N/A" as they are "For mammography displays," and the device is explicitly stated as "not meant to be used in digital mammography." The compliance is "implied" because the document concludes that "The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device."
2. Sample Size Used for the Test Set and the Data Provenance
The document describes physical laboratory tests on the device itself. Thus, the "sample size" is the single device (JVCKENWOOD 6MP Color LCD Monitor CL-S600) undergoing testing. There isn't a "test set" of patient data in the context of an AI algorithm evaluation. The provenance of the data is the physical testing conducted by the manufacturer, JVCKENWOOD Corporation, in Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for a medical display device's technical performance testing. Ground truth for display performance is established by objective physical measurements against established industry standards (e.g., ISO, AAPM-TG18, IDMS, IEC).
4. Adjudication Method for the Test Set
Not applicable for technical performance testing of a physical device. Objective measurements are used.
5. 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 device is a medical display monitor, not an AI algorithm for diagnostic interpretation. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical display monitor, not an AI algorithm. Its performance is inherent in its hardware and firmware capabilities to accurately display images.
7. The Type of Ground Truth Used
The "ground truth" for the device's technical performance is defined by established international and industry standards for medical displays, such as:
- ISO 13406-2 for pixel defects
- AAPM-TG18 for luminance response and artifacts
- IDMS 1.03 (Information Display Measurements Standard) for various display characteristics
- AAPM-TG196 for gray tracking
- IEC 62563-1 for greyscale chromaticity evaluation
- DICOM GSDF (Grayscale Standard Display Function) for luminance characteristics.
These standards provide objective, quantifiable benchmarks for display performance.
8. The Sample Size for the Training Set
No "training set" is applicable for this device. This is a display monitor, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
No "training set" or corresponding ground truth establishment is applicable for this device.
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