(16 days)
20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor ME205 (ML20205) 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.
ME205 (ML20205) is a 20.1-inch (51 cm) Monochrome LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).
The provided document describes the 510(k) premarket notification for the JVC KENWOOD CORPORATION's 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205). The document primarily focuses on establishing substantial equivalence to a predicate device (ME201L, K021738) rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.
However, based on the Technical Specification and Substantial Equivalence Comparison sections, we can infer some performance criteria and how the device (ME205) is claimed to meet them, primarily by comparison to its predecessor and adherence to display standards.
Here's an analysis based on the provided text, specifically addressing the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Technical Specification") | Reported Device Performance (ME205 (ML20205)) | Basis for Performance Claim |
|---|---|---|
| Luminance Uniformity | Less than 30% based on AAPM-TG18 4.4 | "Refer to actual Luminance uniformity data" (data not provided in this document) |
| Pixel Defects / Fault | Class II or more (in context of ISO13406-2) | ISO13406-2 (standard adherence) |
| Artifacts (flicker, ringing, ghosting, image sticking) | No flicker, ringing, ghosting, and image sticking by visible check | "By visible check" |
| Chromaticity Measurement (at 5%, 50%, 95% Level) | "Refer to actual data" (data not provided) | - |
| Chromaticity (Delta (u', v') at 80% Lmax) | ≤ 0.01 based on AAPM-TG18 4.8.4 | "Refer to Chromaticity actual data" (data not provided) |
| Power On Luminance Drift | "Refer to actual data" (data not provided) | - |
| Maximum Luminance | 410 cd/m² DICOM calibrated; 1000 cd/m² typ. As LCD component | Specification (higher than predicate's 700 cd/m² for LCD component) |
| Luminance Calibration | Software-based calibration, Photo Sensor (optional): X-Rite Chroma 5 | Feature description |
| Contrast Ratio | Typ. 1000:1 | Specification |
| DICOM GSDF Compliance | Displays images in accordance with DICOM GSDF by default | "factory calibrated display mode stored in lookup tables" |
| Backlight Stability | Stabilizes luminance | Backlight Sensor feature, LED backlight (longer lasting, stable) |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003 (Class B) | Third-party certifiers and JVC KENWOOD Corporation testing |
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 specify a clinical "test set" sample size or data provenance in the context of a study for diagnostic accuracy. The testing mentioned appears to be related to technical performance characteristics of the monitor itself (e.g., luminance, chromaticity, artifacts) rather than a diagnostic performance study involving medical images and human readers. The "Technical Data" mentioned for comparison with the predicate device is not provided, and its methodology (e.g., sample size of images or tests) is not described.
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 applicable/not provided. The document describes a medical monitor, not an AI or diagnostic device that would require expert-established ground truth for a test set. The "visible check" for artifacts would likely involve internal quality control personnel rather than external medical experts validating ground truth in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. No diagnostic "test set" and thus no adjudication method for ground truth is 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
This information is not applicable/not provided. The device is a medical monitor, 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/not provided. The ME205 (ML20205) is an LCD monitor for displaying medical images, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. The document details the technical specifications and substantial equivalence of a display monitor. Ground truth, in the context of clinical diagnostic accuracy, is not relevant to this type of device submission. The "ground truth" here would be the physical measurements of the monitor's performance characteristics against industry standards (e.g., AAPM-TG18, ISO13406-2) and its own specifications.
8. The sample size for the training set
This information is not applicable/not provided. The device is a monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, 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).