(24 days)
24.1 inch (61.1 cm) Color 2M pixel LCD Monitor CCL244 (CL24244) 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.
CCL244 (CL24244) is a 24.1-inch (61.1 cm) Color LCD monitor whose display resolution is 1920 x 1200 (landscape), 1200 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.
This document is a 510(k) premarket notification for a medical display monitor, the JVC KENWOOD CORPORATION's 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244). The information provided focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance or AI-related metrics. Therefore, many of the requested elements are not applicable or cannot be extracted from this type of document.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and reported device performance:
The document doesn't explicitly frame these as "acceptance criteria" and "reported device performance" in a structured table for clinical decision-making metrics. Instead, it lists technical specifications and performance characteristics tested for the device. The "SPEC" column below is derived from the "Technical Specification" section on page 6, and "Reported Device Performance" is inferred from statements like "Refer to actual data" or comparisons to the predicate.
| Acceptance Criteria (from "Technical Specification") | Reported Device Performance (as inferred) |
|---|---|
| 1. Luminance uniformity [SPEC] Less than 30% based on AAPM-TG18 4.4. | Reported: "Refer to actual Luminance uniformity data" (Implies data was collected and met the spec, but numerical performance is not detailed in this document). The device is stated to have "equivalent or superior capability in stabilizing luminance" to the predicate. |
| 2. Pixel Defects / Fault [SPEC] Class II or more. ISO13406-2 | Reported: Performance meets or exceeds Class II (ISO13406-2). (No specific numerical defect count is provided, but meeting the class implies performance within the standard). |
| 3. Artifacts (phase/clock issues flicker, miscellaneous including ringing, ghosting, image sticking) [SPEC] By visible check, no flicker, ringing, ghosting and image sticking | Reported: "By visible check, no flicker, ringing, ghosting and image sticking" (Directly states it meets the criteria by visual inspection). No specific metrics are given for "reported device performance" beyond this qualitative statement. |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level [SPEC] Refer to actual data. | Reported: "Refer to actual data." (Implies data was collected, but not provided in this document). |
| 5. Chromaticity [SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 | Reported: "Refer to Chromaticity actual data." (Implies data was collected and met the spec, but numerical performance is not detailed in this document). The device is stated to have "equivalent display performances" to the predicate, and both display images "in accordance with DICOM GSDF." |
| 6. Power On Luminance Drift [SPEC] Refer to actual data. | Reported: "Refer to actual data." (Implies data was collected, but not provided in this document). The device "achieves equivalent or superior capability in stabilizing luminance to that of the predicate device." |
| Other relevant performance points mentioned: | Reported: |
- Maximum Luminance: Both devices have 300 cd/m². The proposed device's DICOM calibrated luminance is 200 cd/m² (higher than predicate's 120 cd/m²).
- Backlight: LED backlight used, which "lasts longer than the conventional CCFL's" and "consumes less power and deteriorates more slowly." No adverse effects on image quality from LED backlight recognized. |
| Safety and EMC Standards | The device was "validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers." Specific standards listed for CCL244: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003 (Class B), CCC. |
2. Sample size used for the test set and the data provenance:
This document describes a medical display monitor, not an AI or diagnostic algorithm. Performance evaluation for a monitor primarily involves testing the physical display unit(s) against technical specifications. Therefore, the concept of a "test set" and "data provenance" as typically used for AI or diagnostic studies (e.g., patient cases, retrospective/prospective data) does not apply here. The tests would be performed on the manufactured device models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Again, for a medical display monitor, the "ground truth" is typically objective physical measurements and adherence to technical standards. There isn't a "ground truth" established by medical experts in the context of clinical interpretation for this device. Calibration against standards like AAPM-TG18 would be performed using specialized equipment and trained technicians, not radiologists establishing clinical ground truth.
4. Adjudication method for the test set:
Not applicable. This is not a study involving human interpretation of medical images where adjudication methods like "2+1" or "3+1" would be used. Device performance is determined by objective technical measurements.
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 device is a display monitor, not an AI-powered diagnostic tool. No MRMC study or AI-assistance evaluation was conducted or is relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a hardware device (display monitor), not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance relies on objective technical specifications and internationally recognized standards. For example:
- Luminance uniformity, chromaticity, power-on luminance drift: Measured against quantitative specifications derived from standards like AAPM-TG18.
- Pixel defects: Assessed against ISO13406-2 standard for LCD pixel defects.
- Artifacts: Assessed by visual inspection against qualitative criteria of "no flicker, ringing, ghosting, image sticking."
- Safety and EMC: Assessed by compliance with relevant international standards (e.g., IEC60601-1, ANSI/AAMI ES60601-1, FCC Class B).
8. The sample size for the training set:
Not applicable. This device is a hardware display monitor and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established:
Not applicable for the reason stated in point 8.
§ 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).