(66 days)
The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
CX30N(CX30PQX) 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 text describes the 510(k) summary for the CX30N(CX30PQX) LCD Monitor System, which is a medical image display device. It is important to note that this document is for a medical monitor, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like MRMC studies, ground truth establishment for training/test sets, or expert consensus for labeling) are not applicable here.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the technical performance specifications of the monitor and the tests conducted to demonstrate that the monitor meets these specifications and relevant safety standards for its intended use as a medical display.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a medical display like the CX30N(CX30PQX) are typically based on industry standards and performance specifications for medical imaging. The document highlights a comparison with a predicate device, which implicitly defines common performance expectations.
| Parameter | Acceptance Criteria (Implied / Predicate Performance) | Reported Device Performance (CX30N(CX30PQX)) |
|---|---|---|
| Intended Use | Display and view digital medical images for review and analysis by trained medical practitioners. (Not for mammography) | Display and view digital medical images for review and analysis by trained medical practitioners. (Not for mammography) |
| LCD Panel Size | 21.3" | 21.3" |
| Resolution | 2048 x 1536 | 2048 x 1536 |
| Pixel Pitch | 0.21mm x 0.21mm | 0.2109mm x 0.2109mm |
| Brightness | 1000 cd/m² (Predicate) | 900 cd/m² |
| Contrast Ratio | 1500:1 (Predicate) | 1400:1 |
| Input Signal | DVI-D, DisplayPort (Predicate) | DVI-I, DisplayPort |
| Safety | Compliance with IEC 60601-1 | Complies with IEC 60601-1 |
| EMC | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Effectiveness | Meeting standards for resolution, luminance, contrast, and noise. | Tests met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
For a medical monitor, the "test set" does not refer to clinical image data in the same way it would for an AI/ML algorithm. Instead, the testing involves the device itself.
- Sample Size: The document implies that testing was conducted on the CX30N(CX30PQX) device as a unit. It doesn't specify a "sample size" in terms of multiple devices, typically performance testing like resolution, luminance, contrast, and noise are done on prototypes or production samples to ensure they meet specifications.
- Data Provenance: Not applicable in the context of clinical image data. The "data" here are the performance measurements of the monitor itself. The manufacturer is WIDE Corporation, located in the Republic of Korea. The testing would have been conducted by the manufacturer or accredited testing labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For a medical monitor, "ground truth" is established through physical measurement standards and calibration, not expert interpretation of images. The performance of the display is objectively measured against technical specifications and international standards (e.g., luminance, resolution). Human experts are the users of the display, not the ones establishing its ground truth.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to the review of image data (e.g., for disease diagnosis) where there might be inter-reader variability. For a display device, performance measurements like brightness or resolution are objectively quantifiable and don't require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is a clinical study design used to evaluate the diagnostic performance of a medical imaging system or a CAD (Computer-Aided Detection)/AI device by assessing how human readers' diagnostic accuracy changes with and without the assistance of the device, across multiple cases. This is not applicable to a digital medical display itself, which is a display hardware, not a diagnostic aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The CX30N(CX30PQX) is a display device, not an algorithm. Its "performance" is its ability to accurately display images according to specifications, not to interpret or diagnose.
7. The Type of Ground Truth Used
The ground truth for this device (a medical monitor) is based on:
- Technical Specifications: Defined parameters like resolution (e.g., 2048x1536 pixels), pixel pitch, brightness (cd/m²), contrast ratio, and input signal compatibility.
- International Standards: Compliance with recognized safety and performance standards such as IEC 60601-1 (general safety) and IEC 60601-1-2 (electromagnetic compatibility).
- Measured Performance: Calibration and testing results (e.g., resolution, luminance, contrast, noise) demonstrating that the device meets these specifications and standards.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware display and does not involve AI/ML algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As explained above, there is no AI/ML training set for this device.
In summary, for the CX30N(CX30PQX) LCD Monitor System:
The acceptance criteria are primarily technical specifications and compliance with international safety and performance standards for medical displays. The study proving these criteria are met involves non-clinical bench testing to measure parameters like resolution, luminance, contrast, and noise, and to verify compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that "No clinical studies were considered necessary and performed," which is typical for a device like a monitor where performance is assessed through engineering and physical measurements rather than clinical diagnostic accuracy studies.
§ 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).