(22 days)
6M pixel 30.0 inch Color LCD Monitor CCL650i2 (CL30650. MD302C6) 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.
CCL650i2 (CL30650, MD302C6) is a 6M 30.0-inch Color LCD monitor whose display resolution is 3280 x 2048 supporting DVI (digital visual interface) and DisplayPort.
The provided text describes a 510(k) summary for a medical display monitor, the JVC KENWOOD 6M 30.0 inch Color LCD Monitor CCL650i2 (CL30650, MD302C6). The document aims to demonstrate substantial equivalence to a predicate device, the 21.3 inch (54 cm) Color LCD Monitor CCL358i2 (CL21358) (K133185).
However, the document does not contain information typically found in a study proving a device meets acceptance criteria for an AI/CADe medical device, but rather for a display monitor. Therefore, many of the requested fields regarding AI/CADe performance studies (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.
The acceptance criteria described relate to the monitor's technical specifications and performance, demonstrating equivalency to a predicate device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the device's technical specifications and compares them to a predicate device to demonstrate substantial equivalence, rather than listing explicit "acceptance criteria" against which performance is measured in a quantitative study with pass/fail metrics. However, based on the "Technical Specification" and "Substantial Equivalence Comparison" sections, the following can be inferred as performance aspects that needed to be met or shown as equivalent/superior to the predicate:
| Acceptance Criteria (Inferred from Technical Specifications & Equivalence) | Reported Device Performance (CCL650i2) |
|---|---|
| Luminance Uniformity | Less than 30% based on AAPM-TG18 4.4. (Note: "Refer to actual Luminance uniformity data" implies this was tested and met, but the specific 'actual data' is not provided in this summary.) |
| Pixel Defects / Fault | Class II or more (ISO13406-2). (Note: "Refer to actual data" implies this was tested and met, but specific 'actual data' is not provided in this summary.) |
| Artifacts (pixel defects/faults, ringing, ghosting, image sticking) | Not explicitly quantified, but adherence to ISO13406-2 for pixel defects is mentioned. The general conclusion states "None of the tests revealed behaviors inconsistent with the expected performance." |
| Chromaticity Measurement (5%, 50%, 95% Level) | Not explicitly quantified, but "Refer to actual data" implies this was tested and met. |
| Chromaticity (Delta (u', v')) | ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4. (Note: "Refer to actual chromaticity data" implies this was tested and met, but specific 'actual data' is not provided in this summary.) |
| Maximum Display Resolution | 3280 x 2048 dots (twice or more larger than predicate's 1536 x 2048). |
| Active Display Area | Horizontal: 645.504mm, Vertical: 403.0464mm (larger than predicate). |
| DICOM Calibrated Luminance | 410 cd/m² (same as predicate). |
| Typical Maximum Luminance | 800 cd/m² (same as predicate). |
| Backlight Type | LED (same as predicate, considered beneficial due to mercury-free, less power, slower deterioration). |
| DICOM GSDF Compliance | Images displayed in accordance with DICOM GSDF by default utilizing factory calibrated display mode (same as predicate). |
| Input Signal Support | DVI and DisplayPort (same as predicate). |
| Pixel Pitch | 0.197 x 0.197mm (smaller than predicate's 0.2115 x 0.2115mm, indicating finer display). |
| Safety and EMC Standards Compliance | Validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers (ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC Class B, MDD/CE, VCCI-B Class B, same as predicate). JVC KENWOOD Corporation performed additional system and performance tests, with no inconsistent behaviors found. |
| Calibration Software and Sensor | Software: Medivisor Nx, Calibration Sensor: Chroma5 (X-Rite) (same as predicate). |
| Built-in Sensors | Front Sensor and Ambient Light Sensor (same as predicate, with front sensor enabling automatic grayscale calibration). |
2. Sample size used for the test set and the data provenance
This information is not applicable as this is a medical display device, not an AI/CADe system processing medical images for diagnostic tasks using a test set of patient data. The "tests" performed relate to the monitor's physical performance characteristics and compliance with technical standards.
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 for a medical display device. The "ground truth" here refers to the physical and electrical characteristics of the monitor meeting specified technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for a medical display device.
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 as 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
This information is not applicable as this is a medical display device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to established technical specifications and international standards (e.g., AAPM-TG18, ISO13406-2, ANSI/AAMI ES60601-1, FCC, etc.) that the monitor's performance characteristics must meet.
8. The sample size for the training set
This information is not applicable for a medical display device.
9. How the ground truth for the training set was established
This information is not applicable for a medical display device.
§ 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).