(53 days)
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, and diagnosis by trained medical practitioners.
The Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images
The provided document is a 510(k) summary for the LG Electronics Inc. device, 21HQ613D, which is a medical monitor. This document states that no clinical studies were considered necessary and performed to demonstrate substantial equivalence.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning performance metrics that would typically come from clinical trials or standalone algorithm performance studies, cannot be extracted from this document in the manner requested (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, specific ground truth types for training/test sets, training set sample size).
The document instead focuses on demonstrating substantial equivalence to predicate devices through non-clinical technical performance testing against established standards and guidance for display devices, and through comparison of technological characteristics.
Here is what can be extracted regarding the non-clinical acceptance criteria and reported performance:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document refers to technical performance items tested according to the "Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017." While specific numerical acceptance criteria are not explicitly stated within this document for each measurement (e.g., "MTF must be X" or "pixel defects must be less than Y"), the "SE Note" for each item indicates that the device's performance was considered "Equivalent" or "Same" to predicate devices, implying it met the expected performance targets set by the guidance for substantial equivalence.
| Measurements | Description | Reported Device Performance (SE Note) |
|---|---|---|
| Spatial resolution | Measurements of the transfer of information from the image data to the luminance fields at different spatial frequencies of interest typically done by reporting the modulation transfer function. | Equivalent |
| Pixel defects | Measurements (count, types (e.g., sub-pixel or entire pixel, always-on, always-off), and locations (map) of pixel defects. | Equivalent |
| Artifacts | Evaluate for image artifacts such as ghosting and/or image sticking from displaying a fixed test pattern for a period of time. | Same |
| Temporal response | Measurements of the temporal behavior of the display in responding to changes in image values from frame to frame. | Equivalent |
| Luminance | Measurements of the maximum and minimum luminance that the device outputs as used in the application under recommended conditions and the achievable values if the device is set to expand the range to the limit. | Same |
| Conformance to a grayscale-to-luminance function | Measurements of the mapping between image values and the luminance output following a target model response for 256 or more levels. | Equivalent |
| Luminance at 30° and 45° in diagonal, horizontal, and vertical | Measurements of the luminance response at off-normal viewing related to the target model for the luminance response. | Equivalent |
| Luminance uniformity or Mura test | Measurements of the uniformity of the luminance across the display screen. | Equivalent |
| Stability of luminance and chromaticity response | Measurements of the change in luminance and chromaticity response with temperature and use time. | Same |
| Spatial noise | Measurements of the spatial noise level as represented by the noise power spectrum using an appropriate ratio of camera and display pixels. | Equivalent |
| Reflection coefficient | Measurements of the reflection coefficients of the display device. | Same |
| Veiling glare or small-spot contrast | Measurements of the contrast obtained for small targets. | Equivalent |
| Color tracking | Chromaticity at different luminance levels of primary colors as indicated by the color coordinates. | Equivalent |
| Gray tracking | Chromaticity at different luminance levels of gray shades, including the white point. | Equivalent |
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical studies with test sets of medical images were performed. The testing was instrumental, evaluating the display's physical performance characteristics as a device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a medical monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. The "ground truth" for the non-clinical tests would be the established engineering specifications and performance standards for display monitors used in diagnostic radiology.
8. The sample size for the training set: Not applicable, as this is a hardware device (monitor), not an AI algorithm requiring a training set.
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).