(64 days)
CL-S500 and MS-S500 are intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of luminance and color on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted
MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.
The acceptance criteria for the JVC Kenwood CL-S500 (color) and MS-S500 (monochrome) LCD monitors, intended for medical image display in digital mammography PACS, digital breast tomosynthesis, and FFDM, are based on a comparison to a predicate device (CCL550i2/ K160326) and adherence to established display quality standards (AAPM-TG18 and ISO13406-2).
The study primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and performance of the new devices to the predicate device and relevant industry standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" as a separate, quantitative target for each metric beyond direct comparison to the predicate device or a reference to a standard (e.g., AAPM-TG18 passing criteria). However, the "Explanation of Differences" column in the substantial equivalence comparison tables implicitly suggests the acceptance criteria where the new device must be equivalent to or better than the predicate, or meet the requirements of the specified standard.
| Metric (Acceptance Criteria Implicitly Derived) | Predicate Device Performance (CCL550i2) | CL-S500 Performance (Color) | MS-S500 Performance (Monochrome) | Explanation / Conformance |
|---|---|---|---|---|
| Response Time (typical) | 25ms (On/Off) | 25ms (On/Off) | 25ms (On/Off) | Equivalent |
| Resolution or Matrix Size | 5MP (2048 x 2560) | 5MP (2048 x 2560) | 5MP (2048 x 2560) | Equivalent |
| Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | CL-S500 Equivalent; MS-S500 different (monochrome) but intended use is for monochrome imaging, so acceptable. |
| Backlighting | LED | LED | LED | Equivalent |
| Maximum Luminance | Min. 700cd/m², Typ. 1000cd/m² | Min. 920cd/m², Typ. 1150cd/m² | Min. 2400cd/m², Typ. 3000cd/m² | CL-S500: Better; MS-S500: Better |
| DICOM Calibrated Luminance | 500cd/m² | 500cd/m² | 1000cd/m² | CL-S500: Equivalent; MS-S500: Better |
| Viewing Angle (CR > 50) | H: Typ. 176°, V: Typ. 176° | H: Typ. 178°, V: Typ. 178° | H: Typ. 178°, V: Typ. 178° | Both: Better |
| Display Area | 337.92mm (H), 422.4mm (V) | 337.92mm (H), 422.4mm (V) | 337.92mm (H), 422.4mm (V) | Equivalent |
| Aspect Ratio | 4:5 | 4:5 | 4:5 | Equivalent |
| Pixel Pitch | 0.165mm (H), 0.165mm (V) | 0.165mm (H), 0.165mm (V) | 0.165mm (H), 0.165mm (V) | Equivalent |
| Contrast Ratio | Min. 1000:1, Typ. 1300:1 | Min. 1600:1, Typ. 2000:1 | Min. 1600:1, Typ. 2000:1 | Both: Better |
| Grayscale Tones (DisplayPort) | 10-bit (1024 from 65,473) | 10-bit (1.073B, 1024 from 16,369) | 10-bit (1024 from 16,369) | CL-S500: Different palette size, but passes AAPM-TG18. MS-S500: Different palette size, but passes AAPM-TG18. Considered equivalent as they meet standard. |
| Non-Uniformity Compensation | Digital Uniformity correction System | Digital Uniformity correction System | Digital Uniformity correction System | Equivalent |
| Input Video Signal | DVI-D x1, DisplayPort x1 | DVI-D x1, DisplayPort x1 | DVI-D x1, DisplayPort x1 | Equivalent |
| Scanning Frequency | Portrait: H:129.1KHz, V:50Hz; Landscape: H:103.5KHz, V:50Hz | Portrait: H:129.1KHz, V:50Hz; Landscape: H:103.5KHz, V:50Hz | Portrait: H:129.1KHz, V:50Hz; Landscape: H:103.5KHz, V:50Hz | Equivalent |
| Dot Clock | 285 MHz | 285 MHz | 285 MHz | Equivalent |
| Power Requirements | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | Equivalent |
| Power Consumption | 95W (operational), |
§ 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).