(30 days)
The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The C32SP+/C32S+ 3MP Color LCD Display is a display system for medical viewing, with high resolution 2048 x 1536, built-in brightness stabilization circuit and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
The provided document is a 510(k) Summary for a 3MP Color LCD Display (C32SP+/C32S+) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the manner of an AI/human performance study. The document states that "All of parameters comply with 21CFR1020.33 and related IEC standards" and that the differences "do not affect the safety and effectiveness (SE)." This suggests that acceptance criteria would be defined by adherence to these standards and the comparison tables to the predicate device.
Given the nature of the document as a 510(k) submission for an LCD display, it focuses on technical specifications and substantial equivalence rather than clinical performance or human-in-the-loop studies typically associated with AI-powered devices. No information is present regarding:
- Sample sizes for test sets or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
Therefore, the requested information elements cannot be fully populated as they are not within the scope of this document.
However, based on the comparative tables provided, we can infer the acceptance criteria are alignment with the predicate device's specifications and compliance with relevant standards. The reported device performance is its technical specifications as listed.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly defined by the parameters of the predicate device and relevant standards (21CFR1020.33, IEC 60601-1, IEC 60601-1-2). The reported device performance is its specifications, which are presented as comparable or superior to the predicate.
| Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (C32SP+/C32S+) |
|---|---|
| Panel Size and Type: 21.3", TFT LCD display | 21.3", TFT LCD display |
| Pixel Pitch: 0.2115 mm | 0.2115 mm |
| Native Resolutions: 2048 x1536 | 2048 x1536 |
| Brightness: 1700 cd/m² (or comparable) | 1700 cd/m² |
| Contrast Ratio: 1300:1 (or comparable/better) | 1400:1 (considered better) |
| Network Interface: USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| Active Display Size: 433.2mm x324.9mm (or comparable) | 433.152mm x324.864mm |
| Operating Temperature: 0°C ~ 40°C | 0°C ~ 40°C |
| Transport/Storage Temperature: -20°C ~ 60°C | -20°C ~ 60°C |
| Operating Relative Humidity: 8% ~80% (non-condensing) | 15%~85% |
| Transport/Storage Relative Humidity: 5% ~95% | 10%~90% |
| Power Capacity: |
§ 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).