(101 days)
CL-S301 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.
21.3 inch Color LCD Monitor
1536 x 2048 (portrait)
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 FDA 510(k) summary is for a medical monitor (3MP Color LCD Monitor CL-S301), not an AI device. Therefore, much of the requested information regarding AI device acceptance criteria, study design, and performance metrics (e.g., sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable or cannot be extracted from this document, as it pertains to the performance evaluation of a display hardware.
However, I can extract the acceptance criteria and performance data related to the physical characteristics of the monitor, as well as general information about its intended use and comparison to a predicate device.
Here's the available information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents performance "test items in the guidance" which serve as acceptance criteria for a medical display monitor. The "test method(s)" column describes how these criteria are verified. The conclusion states that "The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device." This implicitly means the device met the acceptance criteria for each test.
| Performance test items in the guidance | Test method(s) (Implicitly indicating criteria met) |
|---|---|
| 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. |
| 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. |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests; IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES |
| 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. |
| e. Luminance (maximum, minimum, achievable, and recommended) | Lmin and Lmax on the calibrated luminance are confirmed. |
| 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. |
| g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| h. Luminance uniformity or Mura test (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| i. Stability of luminance and chromaticity response with temperature and time of operation or on-time (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| j. Spatial noise (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| k. Reflection coefficient (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| l. Veiling glare or small-spot contrast (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| 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. |
| 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. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to a physical display device. The tests are performed on the device itself, not on
a "data set" in the context of an AI algorithm. The device manufacturer is JVCKENWOOD Corporation, located in Japan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "ground truth" for a monitor's performance is based on physical measurements and adherence to technical standards (e.g., ISO, IDMS, AAPM-TG directives), not expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for evaluating expert performance on diagnostic tasks, not for physical device testing.
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
This is not applicable. An MRMC study is used to evaluate the diagnostic performance of a system (often AI-assisted) with human readers. This document describes a monitor, which is a display hardware, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the monitor's performance is defined by adherence to established technical standards and measurement protocols (e.g., ISO 13406-2, IDMS 1.03, AAPM-TG18/196, IEC 62563-1).
8. The sample size for the training set
This is not applicable. The device is a physical monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).