(59 days)
The CX50N(CX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
CX50N(CX50YQS) is a flat panel hi-resolution(5MP) LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
Here's the breakdown of the acceptance criteria and study information for the CX50N(CX50YQS) LCD Monitor System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from International/FDA-recognized consensus standards) | Reported Device Performance (CX50N(CX50YQS)) |
|---|---|---|
| Resolution | Met acceptance criteria specified in the standards | Meets standards |
| Luminance (Brightness) | Met acceptance criteria specified in the standards | Meets standards |
| Contrast | Met acceptance criteria specified in the standards | Meets standards |
| Noise | Met acceptance criteria specified in the standards | Meets standards |
| Electrical Safety | IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance | Complies (validated through tests) |
| Electromagnetic Compatibility | IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests | Complies (validated through tests) |
Note: The document states that the individual tests (resolution, luminance, contrast, noise) "all met the acceptance criteria specified in the standards," but it does not explicitly list the numerical acceptance criteria from those standards. The reported device performance is that it "meets standards."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This device is an LCD monitor system, and the non-clinical testing focused on physical performance characteristics against established standards, not on evaluating diagnostic accuracy using a dataset of medical images.
- Data Provenance: Not applicable for a traditional test set as described for AI/ML devices. The testing involved measurements of the monitor's physical characteristics and compliance with electrical and EMC standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth, in the context of medical image interpretation, is not established for this type of device (a display monitor) in this submission. The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the referenced international standards.
4. Adjudication Method for the Test Set
- Not applicable. There was no image interpretation test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an LCD monitor, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is an LCD monitor system, not an algorithm. Performance testing was of the hardware itself against technical standards.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical performance and safety tests was the established technical specifications and limits defined within the cited international and FDA-recognized consensus standards (e.g., IEC 60601-1, IEC 60601-1-2).
8. The Sample Size for the Training Set
- Not applicable. This device is an LCD monitor system and does not involve AI/ML requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is an LCD monitor system and does not involve AI/ML requiring a training set.
§ 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).