(259 days)
The Medical LCD Monitors are intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specifications of the system.
The Medical LCD Monitors are designed for the purpose of medical applications such as X-ray, radiology, MRI or endoscopy imaging display. The high-resolution LCD panels with a resolution of 1280x1024, 1600x1200, 2048x1536 or 2560x2048, combined with a high-performance image processing controller, provides the users extremely high-definition and high-quality medical image displays. These medical monitors comply with international EMC/ safety standards.
The provided text is a 510(k) summary for a Medical LCD Monitor (Kostec Co., Ltd., K123944). This type of document is for demonstrating substantial equivalence to a predicate device and does not typically contain detailed information about specific clinical studies or performance against acceptance criteria in the way that would be found for an AI/ML medical device submission.
Medical LCD Monitors are display devices, not diagnostic algorithms. Their performance is generally assessed against technical and international standards for image display quality, electrical safety, and electromagnetic compatibility. The "acceptance criteria" for such a device are these compliance standards and the ability to display medical images accurately.
Therefore, many of the questions asked, particularly those related to sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment for training data, are not applicable to this type of device and submission.
Here's a breakdown of the available information based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are compliance with various international standards. The document states that the device has been tested against and passed these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1:2006, General Requirements for Electrical Safety | Passed |
| IEC 60601-1-2:2007, Electromagnetic Compatibility | Passed |
| NEMA PS 3.1-3.18:2009 Digital Imaging and Communication (DICOM) in Medicine | Complies (implied by "device complies with the performance specifications of the system" and general reference to DICOM standard) |
| BS/EN 61000-3-2:2006+a2:2009, Electromagnetic compatibility (EMC). Limits for harmonic current emissions | Passed |
| BS/EN61000-3-3:2008, Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection | Passed |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable/Not specified in the document. Performance is based on technical testing of the monitor units, not analysis of medical image datasets.
- Data provenance: Not applicable. The "data" here refers to the performance characteristics of the monitor itself, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for a medical display monitor. The "ground truth" for display performance is established by technical specifications and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human interpretation of images.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical monitor, not an AI diagnostic algorithm. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is hardware (monitor), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense. The "ground truth" for a medical monitor's performance is adherence to established technical specifications and international standards for image display, electrical safety, and electromagnetic compatibility.
8. The sample size for the training set
- Not applicable. There is no "training set" for a medical LCD monitor in the context of an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).