(18 days)
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis
MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor. Their displays' resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.
Here's a breakdown of the acceptance criteria and study information for the JVC Kenwood medical monitors, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the JVC KENWOOD monitors (MS55i2 and CCL550i2) primarily focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce GX540) rather than presenting specific, quantitative acceptance criteria and results. The "acceptance criteria" can be inferred as matching or being equivalent to the key performance specifications of the predicate device, especially those related to image quality and functionality for diagnostic medical imaging.
| Feature / Acceptance Criteria (Inferred from Predicate Equivalence) | Predicate Device (EIZO RadiForce GX540) Specification | JVC KENWOOD MS55i2 (ML21055, MD211G5) Performance | JVC KENWOOD CCL550i2 (CL21550) Performance |
|---|---|---|---|
| Response Time (typical) | 25ms (On/Off) | 25ms (On/Off) | 25ms (On/Off) |
| Resolution or Matrix Size | 5MP (2048 x 2560) | 5MP (2048 x 2560) | 5MP (2048 x 2560) |
| Screen Technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | TFT Color LCD Panel (IPS) |
| Backlighting | LED | LED | LED |
| Maximum Luminance | Min. 850cd/m², Typ. 1200cd/m² | Min. 850cd/m², Typ. 1200cd/m² | Min. 700cd/m², Typ. 1000cd/m² |
| DICOM Calibrated Luminance | 500cd/m² | 500cd/m² | 500cd/m² |
| Viewing Angle (CR>50) | Horizontal: Typ. 176°, Vertical: Typ. 176° | Horizontal: Typ. 176°, Vertical: Typ. 176° | Horizontal: Typ. 176°, Vertical: Typ. 176° |
| Display Area | Horizontal: 337.92mm, Vertical: 422.4mm | Horizontal: 337.92mm, Vertical: 422.4mm | Horizontal: 337.92mm, Vertical: 422.4mm |
| Aspect Ratio | 4:5 | 4:5 | 4:5 |
| Pixel Pitch | Horizontal: 0.165mm, Vertical: 0.165mm | Horizontal: 0.165mm, Vertical: 0.165mm | Horizontal: 0.165mm, Vertical: 0.165mm |
| Contrast Ratio | Min. 900:1, Typ. 1200:1 | Min. 900:1, Typ. 1200:1 | Min. 1000:1, Typ. 1300:1 |
| Grayscale Tones (10-bit DisplayPort) | 1,024 from a palette of 16,369 tones | 1,024 from a palette of 12,277 tones | 1,024 from a palette of 65,473 tones |
| Grayscale Tones (8-bit) | 256 from a palette of 16,369 tones | 256 from a palette of 12,277 tones | 256 from a palette of 65,473 tones |
| Non-Uniformity Compensation | Digital Uniformity Equalizer (DUE) | Digital Uniformity correction System | Digital Uniformity correction System |
| Input Video Signal | DVI-D x1, DisplayPort x1 | DVI-D x1, DisplayPort x1 | DVI-D x1, DisplayPort x1 |
| QA Software | RadiCS | QA Medivisor / Medivisor NX, F-CAL | QA Medivisor / Medivisor NX, F-CAL |
| Built-in Front Sensor | Integrated Front Sensor (IFS) | Built-in Front Sensor | Built-in Front Sensor |
| Ambient Light Sensor | Ambient Light Sensor (ALS) | Built-in ambient Light Sensor | Built-in ambient Light Sensor |
Explanation of Differences and Performance Justification:
- Grayscale Tones: While the palette size for grayscale tones differs, the document states, "But our monitors pass the exams in AAPM-TG18 4.3 'Luminance Response'. Our monitors are equivalent to the predicated device." This indicates that despite the numerical difference in palette size, the devices meet the relevant image quality standards for grayscale reproduction.
- Non-Uniformity Compensation: The JVC KENWOOD system is considered "equivalent to the predicated device's one" in making visual performance "much better in the point of luminance (monochrome and color version) and chromaticity."
- Maximum Luminance (CCL550i2): The color monitor has a lower maximum luminance, but the document clarifies, "However DICOM Calibrated luminance is same as the predicated device. Then actual performance for diagnosis is the same." This is a crucial point, as the calibrated luminance is what's critical for diagnostic viewing.
- Contrast Ratio (CCL550i2): The color model's contrast ratio is higher, which is generally a positive difference.
2. Sample Size Used for the Test Set and Data Provenance
This document does not contain information about a "test set" in the context of clinical images or patient data. The evaluation is focused on the technical performance specifications of the monitors themselves. Therefore, sample sizes for test sets in this sense are not applicable.
- Data Provenance: The data presented is from the manufacturer's (JVC KENWOOD Corporation) testing and comparison against the specifications of the predicate device. The company is based in Japan. This is more akin to bench testing of hardware specifications rather than a clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a technical comparison of monitor specifications, not an evaluation of diagnostic accuracy based on expert interpretation of images. The "ground truth" here is the adherence to technical standards and performance specifications, likely established through engineering measurements and adherence to industry standards like AAPM-TG18.
4. Adjudication Method for the Test Set
Not applicable, as no human reader studies or clinical test sets requiring adjudication are described.
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 510(k) summary is for medical display monitors and does not involve AI or reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This 510(k) summary is for medical display monitors and does not involve algorithms or AI performance.
7. The Type of Ground Truth Used
The "ground truth" used in this submission is primarily technical specifications and performance measurements against established industry standards (e.g., DICOM, AAPM-TG18) and direct comparison with a legally marketed predicate device. The goal is to demonstrate that the new devices perform equivalently or better in terms of visual characteristics critical for medical image diagnosis.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being developed or trained described in this document.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned in this document.
§ 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).