(101 days)
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, 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
This document describes the 510(k) premarket notification for the LG Electronics 31HN713D Medical Monitor. The submission aims to demonstrate substantial equivalence to a predicate device (BARCO N.V. MDMC-12133, K141428) for displaying radiological images, including full-field digital mammography and digital breast tomosynthesis.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the non-clinical tests performed in accordance with FDA guidance for "Display Devices for Diagnostic Radiology." The reported device performance is indicated by the outcome of these tests being deemed "Equivalent" or "Same" to the predicate device, suggesting the device met the necessary performance standards to be considered substantially equivalent.
| Acceptance Criterion (Implied by Test Item) | Description of Test | 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, typically by reporting the modulation transfer function. Non-isotropic resolution properties characterized by 2D measurements or along at least two representative axes (Using TG18 QC Test Pattern). | Equivalent |
| Pixel defects | Measurements (count, types (e.g., sub-pixel or entire pixel, always-on, always-off), and locations (map) of pixel defects. Provided as a tolerance limit. Pixel defects can interfere with the visibility of small details. | Equivalent |
| Artifacts | Evaluate for image artifacts such as ghosting and/or image sticking from displaying a fixed test pattern for a period of time (Using 5x5 mosaic pattern, 64Gray / 127 Gray judgment). | Same |
| Temporal response | Measurements of the temporal behavior of the display in responding to changes in image values from frame to frame. Rise and fall time constants are needed. Slow displays can alter details and contrast when large image stacks are browsed or in video, panning, and zooming modes. | Equivalent |
| Luminance | Measurements of the maximum and minimum luminance that the device outputs under recommended conditions and achievable values if 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 directions at center and four corners | 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 with temperature and time of operation (on-time) | 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. Spatial noise and resolution affect how images are presented and can alter features relevant to interpretation. | Equivalent |
| Reflection coefficient | Measurements of the reflection coefficients of the display device. Specular and diffuse reflection coefficients can be used as surrogates for the full bidirectional reflection distribution function. | 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 in an appropriate units system (e.g., CIE u'v') and the color gamut enveloped by the primary colors. | Equivalent |
| Gray tracking | Chromaticity at different luminance levels of gray shades, including the white point, as indicated by the color coordinates in an appropriate units system. | Equivalent |
2. Sample Size and Data Provenance (Test Set)
- Sample Size: Not applicable. The "study" described is a series of non-clinical, technical performance tests on the device itself, rather than a study involving patient data or human readers. The tests involve the physical display unit.
- Data Provenance: Not applicable. The tests are conducted on the device hardware and its performance characteristics.
3. Number of Experts and Qualifications (Ground Truth for Test Set)
- Number of Experts: Not applicable. There is no involvement of experts establishing ground truth for a test set in the traditional sense, as this is a device performance test. The "ground truth" for these tests comes from established industry standards and guidance (e.g., TG18 QC Test Pattern) and the technical specifications required for medical diagnostic displays.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (Test Set)
- Adjudication Method: Not applicable. There is no adjudication in the context of the described non-clinical performance tests. The results are based on direct measurements against predefined technical specifications or comparisons to the predicate device's expected performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The document explicitly states: "No clinical studies were considered necessary and performed." This submission focuses on demonstrating substantial equivalence through non-clinical technical performance testing.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Yes, in a way. The tests performed are inherent to the device's standalone performance characteristics as a display monitor. The device itself (the monitor) is tested as a standalone product to ensure it meets the technical specifications for displaying medical images. While it's not an "algorithm," it assesses the fundamental output quality of the device without human interpretation being part of the performance metric.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for these non-clinical tests is derived from technical specifications, industry standards, and regulatory guidance. Specifically, reference is made to:
- IEC 60601-1:2005/AMD1:2012 (Electrical Basic Safety and Essential Performance)
- IEC 60601-1-2 Edition 4.0:2014 (Electromagnetic Compatibility)
- IEC 60601-1-6:2010/A1:2013 (Usability)
- FDA guidance: "Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017"
- Specific test patterns like TG18 QC Test Pattern and 5x5 mosaic patterns are mentioned for certain measurements.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This document pertains to the submission of a medical monitor (hardware), not an AI algorithm that requires a training set. The software validation mentioned is for the display's internal operating software, not for image analysis.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set for an AI algorithm discussed in this submission.
§ 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).