(59 days)
2MP Color LCD Monitor CCL214 (CL21214) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
CCL214 (CL21214) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-D (digital interface) and DisplayPort (digital interface).
This document is a 510(k) Summary for the JVC KENWOOD 2MP Color LCD Monitor CCL214 (CL21214). It does not describe a study involving an AI algorithm or analysis of medical images for diagnostic purposes by AI. Instead, it describes a medical display monitor. Therefore, many of the requested fields are not applicable.
Here's an analysis of the provided text based on your request, focusing on the device and its performance criteria:
Device: 2MP Color LCD Monitor CCL214 (CL21214)
Intended Use: To be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
Predicate Device: 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) (K151134)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Technical Specification) | Reported Device Performance (for CCL214 unless otherwise specified) |
|---|---|
| 1. Luminance uniformity | [SPEC] Less than 30% based on AAPM-TG18 4.4. (The document states this as the specification for the new device, implying it meets this.) |
| 2. Pixel Defects / Fault | [SPEC] Class II or more. ISO13406-2 (The document states this as the specification for the new device, implying it meets this.) |
| 3. Artifacts | [SPEC] By visible check, no flicker, ringing, ghosting and image sticking. (The document states this as the specification for the new device, implying it meets this.) |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level | (No specific performance value provided, but it's a measurement point that would be part of the test.) |
| 5. Chromaticity | [SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 (The document states this as the specification for the new device, implying it meets this.) |
| 6. Power On Luminance Drift | [SPEC] ΔLmax ≤ ±10% within 60 seconds. (The document states this as the specification for the new device, implying it meets this.) |
| Display Area | Horizontal: 432.0mm, Vertical: 324.0mm (Same as predicate) |
| Maximum Resolution | 1200 x 1600 at portrait display, 1600 x 1200 at landscape display (Same as predicate) |
| Pixel Pitch | 0.270 mm x 0.270 mm (Same as predicate) |
| Maximum Luminance (DICOM calibrated) | 250 cd/m² DICOM calibrated (Same as predicate) |
| Maximum Luminance (Typ. As LCD component) | 500 cd/m² typ. As LCD component (Superior to predicate's 440 cd/m²) |
| Contrast Ratio | Typ 1200:1 (Predicate: Typ 1500:1. This is a difference, but the document concludes it does not affect safety or effectiveness.) |
| Safety Standards | 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) (Same as predicate. Validated by third-party certifiers.) |
Study to prove device meets acceptance criteria:
The document states: "JVC KENWOOD Corporation performed the system and performance tests to verify that the CCL214 (CL21214) performs in accordance with its specifications. None of the tests revealed behaviors which is inconsistent with the expected performance."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The testing would involve specific units of the CCL214 monitor. It's not a study on medical images but on the monitor itself.
- Data Provenance: Not applicable in the context of clinical data. The tests were performed by JVC KENWOOD Corporation to verify the monitor's performance against its specifications and international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a hardware specification and performance verification, not a clinical study involving experts determining ground truth on medical images. The "ground truth" here is adherence to technical specifications and international standards (e.g., AAPM-TG18, ISO13406-2, safety standards).
4. Adjudication method for the test set:
- Not applicable. This is a hardware verification, not a clinical study requiring adjudication of expert interpretations.
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:
- No. This is a medical display device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical display device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is objective technical specifications and adherence to international standards (e.g., luminance uniformity
§ 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).