(59 days)
The CX20N(CX20PUX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.
CX20N(CX20PUX) is a flat panel hi-resolution 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 color image display. The WIDE controller board is installed into the PACS workstation computer system to display PACS medical images.
The provided document describes a 510(k) premarket notification for a medical monitor system, CX20N(CX20PUX). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's standalone performance against a disease or condition. As such, the information you're requesting regarding AI performance, human reader improvement, and clinical study details related to a specific medical condition is not applicable to this device or its submission.
The device is a TFT LCD Medical Monitor System intended for displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is not an AI-powered diagnostic tool.
Below is the information specifically related to the acceptance criteria and study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to technical specifications and compliance with international standards for medical electrical equipment. The "acceptance criteria" are implied by adherence to these standards and by demonstrating comparable performance to a predicate device.
| Parameter | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (CX20N(CX20PUX)) |
|---|---|---|
| Technical Characteristics: | ||
| Resolution | 1600 × 1200 (Matches predicate) | 1600 × 1200 |
| Pixel pitch | 0.270mm × 0.270mm (Matches predicate) | 0.270mm × 0.270mm |
| Brightness | Comparable to or better than 770cd/m² (Predicate) | 800cd/m² |
| Contrast Ratio | Comparable to or better than 1100:1 (Predicate) | 1400:1 |
| LCD Panel Size | 21.3" (Matches predicate) | 21.3" |
| Input Signal | DVI-I (Predicate); additional signals acceptable | DVI-I, DisplayPort |
| Power Supply | 100~240 VAC, 50/60Hz (Matches predicate) | 100~240 VAC, 50/60Hz |
| Color/Monochrome | Color (Matches predicate) | Color |
| Safety Standards (Compliance with): | ||
| IEC 60601-1 | General Requirements For Basic Safety And Essential Performance | Complies |
| IEC 60601-1-2 | Electromagnetic Compatibility - Requirements And Tests | Complies |
| Functional Performance (Tests for): | Meets specified criteria | Met Acceptance Criteria |
| Resolution | Met Acceptance Criteria | |
| Luminance | Met Acceptance Criteria | |
| Contrast | Met Acceptance Criteria | |
| Noise | Met Acceptance Criteria |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a medical monitor, not a diagnostic or screening algorithm that processes medical image data. The "test set" in this context refers to the physical device itself undergoing engineering and performance verification tests, not a dataset of patient images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is a medical display monitor, there is no "ground truth" to be established by medical experts for its performance in diagnosing or detecting conditions. The "ground truth" for this device relates to engineering specifications and performance standards, which are verified through technical measurements performed by qualified testers/engineers.
4. Adjudication Method for the Test Set
Not applicable. The evaluation of the device's adherence to technical specifications and international standards typically involves objective measurements and compliance checks performed by engineers, not a consensus-based adjudication by medical professionals.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC comparative effectiveness study is designed to assess the performance of diagnostic tools (e.g., algorithms or human readers) in interpreting medical images, usually in the context of disease detection or characterization. This device is a display monitor, not a diagnostic tool, so such a study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a hardware component (monitor) and does not involve an algorithm for diagnostic or interpretative purposes.
7. The Type of Ground Truth Used
For the technical performance aspects, the "ground truth" is defined by the engineering specifications and established international standards (e.g., IEC 60601-1, IEC 60601-1-2) for medical electrical equipment and displays. Compliance is determined by objective measurements against these predefined standards. For the purpose of 510(k) clearance, the primary "ground truth" for the overall device is its substantial equivalence to the predicate device (K032960) in terms of intended use, technological characteristics, and performance.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. 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).