(47 days)
21.3 inch (54 cm) Color 3M pixel LCD Monitor, CCL358i2 (CL21358) 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.
CCL358i2 (CL21358) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and Display Port.
This document describes the K133185 submission for the TOTOKU CCL358i2 (CL21358) 21.3 inch (54 cm) Color LCD Monitor. It outlines the device's technical specifications and compares them to a predicate device, CCL356i2 (K112604), to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists "Technical Specification" as desired criteria (SPEC) and uses the comparison to a predicate device and internal testing to claim equivalence. The document doesn't explicitly state "acceptance criteria" and "reported device performance" in separate columns, but rather outlines specifications it aims to meet and then discusses how the device meets them, primarily through comparison to a predicate and general testing. I will interpret "SPEC" as the acceptance criteria and the surrounding text as the performance.
| Acceptance Criteria (SPEC) | Reported Device Performance/Verification |
|---|---|
| 1. Luminance uniformity: Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data. | The document states "Refer to actual Luminance uniformity data" which implies data was collected and met this specification. It further claims that the CCL358i2 has "equivalent display performances" to the predicate due to shared characteristics and specific technical details, including the same DICOM calibrated luminance values (410 cd/m2) and typical maximum luminance values (800 cd/m2). The employment of LED backlight is noted to help maintain high luminance constantly and deteriorate more slowly. |
| 2. Pixel Defects / Fault: Class II or more. ISO13406-2. | The document implies compliance with this standard by not marking any deviation or issue with pixel defects and claiming overall equivalent display performance and safety/EMC validation. |
| 3. Artifacts (phase/clock issues flicker, miscellaneous including ringing, ghosting, image sticking): By visible check, no flicker, ringing, ghosting and image sticking. | The document doesn't explicitly detail the "visible check" for artifacts but concludes that "None of the tests revealed behaviors inconsistent with the expected performance," which would encompass artifact checks. It asserts "equivalent display performances" to the predicate device. |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level: SPEC data. | The document states "Refer to Chromaticity actual data" which implies data was collected and met this specification. It also mentions that the devices display images in accordance with DICOM GSDF by default utilizing factory calibrated display mode and lookup tables. It does state "Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4". |
| 5. Chromaticity: Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4. Refer to Chromaticity actual data. | This is directly stated as a specification, and the document implies that "actual data" would show compliance. It also notes that the devices display images in accordance with DICOM GSDF by default utilizing factory calibrated display mode and lookup tables. |
| Additional Implied Criteria/Performance: | |
| DICOM calibrated luminance values | Same as predicate: 410 cd/m2 |
| Typical maximum luminance values | Same as predicate: 800 cd/m2 |
| Contrast Ratio | 1400:1 (for CCL358i2) |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B). "The overall design of the CCL358i2 (CL21358) was validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers." |
| System and performance tests | "JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL358i2 (CL21358) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for test sets regarding the performance criteria (luminance, pixel defects, artifacts, chromaticity). The "study" appears to be a technical comparison and internal testing rather than a clinical study with a defined test set of medical images or patient data. The data provenance is not specified beyond being generated by JVC KENWOOD Corporation, which is based in Japan. The type of study is a technical validation, not a clinical trial, and does not involve patient data, so "retrospective or prospective" is not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The device is a medical display monitor, and the "ground truth" for its performance relates to its technical specifications, not medical diagnoses. Therefore, the "experts" would likely be engineers or display calibration specialists, but their number and specific qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used in medical image interpretation studies, not for the technical validation of a display monitor.
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. The device is a medical display monitor, not an AI-powered diagnostic tool. No MRMC comparative effectiveness study was performed or is relevant to this device's validation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is hardware (a display monitor), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's validation is its adherence to technical specifications and industry standards (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF, safety/EMC standards). This is based on objective measurements and verified through internal testing and third-party certifications, rather than clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
Not applicable. This device is a display monitor, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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).