(47 days)
21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL258i2 (CL21258) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
CCL258i2 (CL21258) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.
The provided text describes the JVC KENWOOD CORPORATION's 21.3 inch (54 cm) Color LCD Monitor CCL258i2 (CL21258). The document is a 510(k) summary, primarily focused on demonstrating substantial equivalence to a predicate device (CCL256i2). It outlines the device's technical specifications and intended use.
Here's an analysis of the acceptance criteria and study information based only on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (SPEC) | Reported Device Performance (CCL258i2) |
|---|---|
| Luminance uniformity: Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data | Not explicitly stated as a numerical value for CCL258i2. The document states: "The high luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights." and "Refer to 'Technical Data' where several image quality characteristics of the proposed device are compared with those of the predicate device." It implies uniformity is addressed through the new backlight technology but doesn't give a specific pass/fail for CCL258i2. |
| Pixel Defects / Fault: Class II or more. ISO13406-2 | Not explicitly stated as a numerical value or pass/fail statement for CCL258i2. |
| Artifacts: • phase/clock issues flicker • miscellaneous including ringing, ghosting, image sticking. By visible check, no flicker, ringing, ghosting and image sticking | Not explicitly stated as a numerical value or pass/fail statement for CCL258i2. The document states: "None of the tests revealed behaviors inconsistent with the expected performance." which would cover this criterion. |
| Chromaticity Measurement of 5%, 50%, 95% Level: data | Not explicitly stated as a numerical value or pass/fail statement for CCL258i2. The document refers to "Chromaticity actual data." |
| Chromaticity: Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4. Refer to Chromaticity actual data | Not explicitly stated as a numerical value or pass/fail statement for CCL258i2. The document refers to "Chromaticity actual data." |
| Maximum Luminance (DICOM calibrated) | 410 cd/m² DICOM calibrated (Same as predicate device) |
| Maximum Luminance (typ. as LCD component) | 900 cd/m² typ. as LCD component (Lower than predicate device's 950 cd/m²) |
| Contrast Ratio | 1400:1 (Higher than predicate device's 900:1) |
| DICOM GSDF compliance | Devices display images in accordance with DICOM GSDF by default utilizing factory calibrated display mode (Implied full compliance). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical study or image dataset. The testing conducted appears to be primarily engineering verification and validation of the device's physical and display characteristics.
- Sample Size: Not applicable in the context of a traditional medical device study with a specific dataset of images. The tests appear to have been performed on the device itself.
- Data Provenance: Not applicable. The "study" here is a technical performance verification of the LCD monitor.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided because the "study" is a technical performance verification of an LCD monitor, not an AI or diagnostic device that requires expert-established ground truth for a test set of medical images. The acceptance criteria relate to physical display characteristics.
4. Adjudication Method for the Test Set
This information is not provided, as it is not relevant to the technical performance verification of an LCD monitor.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic algorithms or devices that radiologists interact with to assess diagnostic performance. The CCL258i2 is an LCD monitor for displaying images, not a diagnostic algorithm itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone evaluation was not done. The device is an LCD monitor, not an algorithm. The testing described focuses on its display capabilities and compliance with technical standards.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance verification would be established against technical standards and specifications (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF), not medical image outcomes or pathology reports. The reference to "actual Luminance uniformity data" and "Chromaticity actual data" suggests measurements were taken against these technical standards.
8. The Sample Size for the Training Set
Not applicable. The device is an LCD monitor; there is no AI algorithm being trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI algorithm being trained, therefore no training set or associated ground truth.
Summary of the Study and Conclusion from the Document:
The "study" described in the 510(k) summary is a technical verification and validation of the CCL258i2 Color LCD Monitor to demonstrate its substantial equivalence to the predicate device (CCL256i2). The manufacturer performed a range of system and performance tests to ensure the device meets its specifications and complies with internationally recognized safety and EMC standards. Key areas of comparison included display characteristics like maximum display size, active area, DICOM calibrated luminance, maximum typical luminance, contrast ratio, input signals, and compliance with DICOM GSDF.
The conclusion is that the CCL258i2 is substantially equivalent to the predicate device regarding technical characteristics, application, and intended use. The differences (LCD panel and power supply) were validated, and the manufacturer determined they do not affect safety or effectiveness. The employment of LED backlight in the new device is cited as an improvement for maintaining high luminance consistently due to slower deterioration.
§ 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).