(28 days)
21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) is intended to be used in displaying medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
CCL210 (CL21210) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).
The provided document is a 510(k) premarket notification for a medical display monitor (JVC KENWOOD Corporation's 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210)). This document details the device's technical specifications and compares it to a predicate device to establish substantial equivalence.
It's important to note that this document describes a display monitor, not an AI-powered diagnostic device or an algorithm that processes medical images. Therefore, many of the requested criteria (e.g., sample size, expert ground truth, MRMC studies, standalone performance) are not applicable or relevant to this type of device.
However, I can extract information related to its technical performance criteria and the justification for its equivalence.
Here's an analysis based on the provided text, focusing on the acceptance criteria for a medical display monitor, recognizing that it's not an AI/algorithm-based device:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from "Technical Specification") | Reported Device Performance (from "Technical Specification" and "Substantial Equivalence Comparison") |
|---|---|
| 1. Luminance uniformity | Less than 30% based on AAPM-TG18 4.4. (Refer to actual Luminance uniformity data) |
| 2. Pixel Defects / Fault | Class II or more. ISO13406-2. |
| 3. Artifacts | By visible check, no flicker, ringing, ghosting, and image sticking. |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level | (Refer to actual data.) |
| 5. Chromaticity | Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4. (Refer to Chromaticity actual data) |
| 6. Power On Luminance Drift | (Refer to actual data.) |
| Maximum Luminance (DICOM calibrated) | 250 cd/m² DICOM calibrated (superior to predicate's 120 cd/m²) |
| Maximum Luminance (typ. As LCD component) | 440 cd/m² typ. As LCD component (superior to predicate's 300 cd/m²) |
| Contrast Ratio | Typ 1500:1 (superior to predicate's 800:1) |
| DICOM GSDF Compliance | Displays images in accordance with DICOM GSDF by default utilizing factory calibrated display mode. |
| Safety and EMC Standards | Complies with Medical Safety: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003 (Class B). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This is a medical display monitor, and the "test set" refers to the individual unit or a small batch of units tested for compliance with performance specifications. It's not testing images or patient data.
- Data Provenance: The testing appears to be internal by the manufacturer (JVC KENWOOD Corporation) and verified by third-party certifiers for safety and EMC standards. The origin of the actual "data" (e.g., luminance measurements) would be from the physical monitor itself during testing procedures.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for a monitor's performance is established by objective physical measurements against established industry standards (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF). While trained engineers or technicians perform these tests, there isn't a concept of "expert ground truth" in the way it applies to diagnostic algorithms interpreting medical images.
4. Adjudication method for the test set:
- Not applicable. Performance is based on direct measurement against predefined numerical specifications and visual inspection against criteria, not on expert adjudication of diagnostic outcomes.
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 monitor, not an AI-powered diagnostic tool. MRMC studies are used to evaluate diagnostic imaging systems or AI algorithms, not passive display devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is a "standalone" display monitor, but it is not an algorithm, and it has no "human-in-the-loop" component in the sense of AI assistance for diagnosis. Its performance is measured as a standalone piece of hardware.
7. The type of ground truth used:
- The "ground truth" for this device's performance is defined by established industry standards and specifications, such as:
- AAPM-TG18 (American Association of Physicists in Medicine Task Group 18) for display quality control.
- ISO13406-2 for pixel defects.
- DICOM GSDF (Grayscale Standard Display Function) for consistent grayscale reproduction.
- IEC 60601-1 for medical electrical equipment safety.
- FCC, MDD/CE, VCCI-B, ICES-003 for electromagnetic compatibility and other regulatory compliance.
- Performance is confirmed through direct physical measurements of the monitor's characteristics (luminance, chromaticity, pixel defects) and visual inspections as per these standards.
8. The sample size for the training set:
- Not applicable. This device does not use an "algorithm" derived from a training set. It's a hardware display whose performance is engineered and then verified.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it. The "ground truth" for the device's design and manufacturing is based on established engineering principles and medical display standards.
§ 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).