(24 days)
21.5 inch (54.5 cm) Color 2M pixel LCD Monitor CCL220 (CL2220) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
CCL220 (CL22220) is a 21.5-inch (54.5 cm) Color LCD monitor whose display resolution is 1920 x 1080 (landscape), 1080 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.
This document describes a 510(k) premarket notification for a medical display monitor, the JVC KENWOOD CCL220 (CL2220). As such, the study described focuses on demonstrating substantial equivalence to a predicate device, rather than on proving performance against clinical endpoints using a traditional clinical trial design with patient data.
Here's a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Technical Specification" as desired criteria (implicitly, acceptance criteria based on industry standards and performance of the predicate device). The performance is largely reported as "Refer to actual data" or a statement of meeting the specification.
| Acceptance Criteria (Technical Specification) | Reported Device Performance |
|---|---|
| 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 (phase/clock issues, flicker, miscellaneous including ringing, ghosting, image sticking) | 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. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a number of monitors tested. The document refers to testing "the CCL220 (CL2220)" in general, implying at least one unit of the device was subjected to these tests.
- Data Provenance: The tests were performed by JVC KENWOOD Corporation as part of their validation process. The "Technical Data" mentioned in section {7} would likely contain the raw data for these tests. The country of origin of the device manufacturer is Japan. The testing is prospective for the purposes of this 510(k) submission, as it was conducted to demonstrate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the traditional sense of medical image interpretation. The "ground truth" for these technical specifications is defined by industry standards (e.g., AAPM-TG18, ISO13406-2) and the technical capabilities of the device itself.
- Qualifications of Experts: The validation was performed by JVC KENWOOD Corporation's engineering and quality assurance teams. While specific qualifications are not listed, it's implied they have the technical expertise to perform these measurements and ensure compliance with the stated standards.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. This is not a study requiring adjudication of diagnostic interpretations. The tests involve objective measurements against predefined technical specifications.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a display monitor, not an AI-powered diagnostic tool. The document compares the new device (CCL220) to a predicate device (CCL208) on technical specifications, not on clinical effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a medical display device, not an algorithm. Its "performance" is based on its ability to accurately and consistently display images according to technical standards.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for these technical tests is primarily defined by:
- Industry Standards: Such as AAPM-TG18 (for luminance uniformity, chromaticity) and ISO13406-2 (for pixel defects).
- Manufacturer Specifications: The inherent design and expected performance characteristics of the display.
- Objective Measurements: Using calibrated equipment to measure luminosity, chromaticity, etc.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. As this device is a hardware display monitor, there is no "training set" in the context of machine learning or AI models. The development and calibration would involve engineering processes and manufacturing tolerances.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. No training set is used for this type of device. The monitor is designed and manufactured to meet specific technical performance benchmarks.
§ 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).