(86 days)
21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently, MS55i2 (ML21055, MD211G5) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
MS55i2 (ML21055, MD211G5) is a 21.3-inch monochrome LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.
Here's an analysis of the provided text regarding the acceptance criteria and study for the JVCKENWOOD MS55i2 monitor.
The document describes a 510(k) premarket notification for a medical display monitor. The "study" in this context refers to product verification and validation testing to ensure the monitor meets specified technical performance criteria, rather than a clinical study involving human readers or patient outcomes, as is common for AI-powered diagnostic devices.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Acceptance Criteria | Reported Device Performance (as stated or implied) |
|---|---|---|
| Display Characteristics | ||
| Screen Size (Active) | Not explicitly stated as "acceptance criteria," but specified in both versions. | Horizontal: 337.92mm, Vertical: 422.4mm (for landscape, opposite for portrait). Actual measured: 422.35mm(H) x 337.95mm(V) |
| Pixel Pitch | Not explicitly stated as "acceptance criteria," but specified. | 0.055mm(H) (sub-pixel pitch) x 0.165mm(V) at landscape display. 0.165mm(H) x 0.055mm(V) (sub-pixel pitch) at portrait display. |
| Maximum Display Resolution | 2048 x 2560 dots | 2048 x 2560 dots |
| Input Signal | DVI, DisplayPort | DVI, DisplayPort |
| Grayscale | Not explicitly stated as "acceptance criteria," but specified. | 10.3 bit (1276 gradation) |
| Luminance | ||
| Maximum Luminance (Calibrated) | (Predicate: Min. 850 cd/m² Typ. 1100 cd/m², Calibrated 500 cd/m²) | Min. 850 cd/m² Typ. 1200 cd/m² (as LCD component), (Calibrated 500 cd/m²) - Improvement noted |
| Max Achievable Luminance | [SPEC] Luminance Max (L.max) = 1200 cd/m² | Spec stated as target. "Refer to actual luminance response data" for confirmation. |
| Min Achievable Luminance | [SPEC] Luminance Min (Lmin) = 0.5 cd/m² | Spec stated as target. "Refer to actual luminance response data" for confirmation. |
| Max Recommended (Operational) Luminance | [SPEC] Luminance Max recommend: Lmax(r) = 500 cd/m² | Spec stated as target. "Refer to actual luminance response data" for confirmation. |
| Min Recommended (Operational) Luminance | [SPEC] Lmin(r) = 0.8 cd/m² | Spec stated as target. "Refer to actual luminance response data" for confirmation. |
| Luminance Calibration Software | Medivisor (Software), Chroma5 (X-Rite) (Sensor) | Medivisor (Software), Chroma5 (X-Rite) (Sensor) |
| Contrast | ||
| Contrast Ratio | (Predicate: Min. 600 Typ. 850) | Min. 900 Typ. 1200 - Improvement noted |
| Viewing Angle | (Predicate: CR>20 Typ. 85 deg) | CR>50 Typ. 176 horizontal/vertical - Improvement noted |
| Grayscale Response (DICOM GSDF Conformance) | ||
| Intrinsic Bit-Depth | [SPEC] 8bit per each subpixel | Spec stated as target. "Refer to actual luminance response data" for confirmation. |
| True Output Bit-Depth | [SPEC] 10.3bit gray scale (1276 steps) achieved by 11bit LUT (Look-up Table) in the Display hardware | Spec stated as target. "Refer to actual luminance response data" for confirmation. |
| Intrinsic Luminance Response (dJND per dP) | [SPEC] dJND per dP |
§ 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).