(19 days)
CL-R211 (CL-R211xxxxx) is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
2MP Color LCD Monitor CL-R211. Resolution: 1600 x 1200 (landscape), 1200 x 1600 (portrait). DVI (digital interface) and DisplayPort (digital interface).
This document describes the JVC Kenwood 2MP Color LCD Monitor CL-R211 (K182539), a medical display intended for diagnostic viewing of medical images. The acceptance criteria and supporting study details are as follows:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance | Basis/Standard |
|---|---|---|
| Luminance Response: Less than ±10% | Confirmed | AAPM-TG18 4.3 |
| Angular Dependencies: More than angle of 20° LR'δ, θ ≥ 175, kδ, θ ≤ 30% | Confirmed | AAPM-TG18 4.4 |
| Luminance Uniformity: Less than 30% | Confirmed | AAPM-TG18 4.4.4 |
| Pixel Defects / Fault: Class II or more | Confirmed | ISO13406-2 |
| Artifacts: No flicker, ringing, ghosting, and image sticking. | Confirmed (By visible check) | N/A (Visible Check) |
| Chromaticity: Δ(u', v') ≤ 0.01 measured at 80% Lmax | Confirmed | AAPM-TG18 4.8.4 |
| Power On Luminance Drift: ΔLmax ≤ ±10% within 60 seconds. | Confirmed | N/A |
| Reflection: (Criteria based on AAPM-TG18 4.2) | Confirmed | AAPM-TG18 4.2 |
2. Sample size used for the test set and the data provenance:
The provided document does not contain information regarding a specific "test set" and its sample size or data provenance in the context of clinical image data. The performance criteria relate to the technical specifications and physical characteristics of the monitor itself. The studies mentioned are standard performance tests for display monitors, not clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is a display monitor, and its performance is evaluated against technical specifications and established standards (like AAPM-TG18 and ISO13406-2), not against clinical ground truth established by medical experts for diagnostic accuracy.
4. Adjudication method for the test set:
This information is not applicable for the reasons stated above.
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 information is not applicable. The device is a display monitor, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable for the reasons stated above. The device is a display monitor, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the device's performance is based on established technical standards and measurements. For example, for luminance response, the ground truth is the specified deviation from a target based on AAPM-TG18 guidelines; for pixel defects, it's the ISO13406-2 standard. For artifacts, it's a "visible check" for the absence of defects.
8. The sample size for the training set:
This information is not applicable. The device is a hardware product (display monitor), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
§ 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).