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510(k) Data Aggregation
(90 days)
8MP Color LCD Monitor CL-R813
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel.
It is not meant to be used in digital mammography.
32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape)
- 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 mura correction functions will help achieve uniformity on the whole screen.
The provided text describes a 510(k) summary for the JVCKENWOOD 8MP Color LCD Monitor CL-R813. It is a submission for a display device, not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and specific ground truth types like pathology or outcomes data) are not applicable to this document.
However, I can extract information regarding the device's technical performance and the tests conducted to demonstrate its characteristics.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance test items from the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" and the methods used. It states that the CL-R813 met "predefined criteria" but does not explicitly provide a table of acceptance criteria with numerical thresholds nor does it report specific numerical performance results for the CL-R813 against those criteria. It only states a qualitative finding of equivalence.
| Performance Test Item | Test Method(s) | Reported Device Performance |
|---|---|---|
| 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. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| 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. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests; IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| 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. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| e. Luminance (maximum, minimum, achievable, and recommended) | Lmin and Lmax on the calibrated luminance are confirmed. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| 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. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| (For color displays) 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. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| (For color displays) n. Gray tracking (gray shades and white point) | AAPM-TG196 Gray Tracking; IEC 62563-1: 2009+AMD1:2016+AMD2:2021, 7.4.9 Greyscale chromaticity evaluation. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a display device, not an AI/ML algorithm that processes a "test set" of medical images from patients. The testing involved evaluating the physical characteristics of the monitor hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for an AI/ML algorithm is not relevant for a display hardware submission.
4. Adjudication method for the test set
Not applicable.
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 is a display device, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
Not applicable. For a display device, the "ground truth" is typically defined by industry standards and objective physical measurements (e.g., spectral characteristics of light, spatial resolution patterns). The document references standards like ISO, IDMS, AAPM-TG18, and IEC.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable.
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