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510(k) Data Aggregation
(134 days)
This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
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 text describes the 510(k) summary for the LG Electronics Inc. device, 21HQ513D, a medical monitor. The document asserts the device's substantial equivalence to a predicate device (K191864, 21HK512D) rather than detailing a specific study to prove it meets acceptance criteria with quantitative performance metrics for diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as pass/fail thresholds in a table. Instead, the document focuses on demonstrating that the proposed device, 21HQ513D, has similar technological characteristics and performance to the predicate device, 21HK512D, through comparative measurements. The "Reported Device Performance" listed below are the characteristics of the proposed device that were compared against the predicate.
| Measurement / Characteristic | Description | Proposed Device (21HQ513D) Performance | Predicate Device (21HK512D) Performance | SE Note (Comparison to Predicate) |
|---|---|---|---|---|
| Technological Characteristics | ||||
| Power Consumption | Electrical power usage of the device. | MAX. 120W, Off Mode ≤ 0.3W | MAX. 85W | Difference (not affecting safety/reliability) |
| LCD Screen | Display panel technology. | TFT LCD | TFT LCD | Same |
| Pixel Pitch | Distance between the centers of two adjacent pixels. | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | Same |
| Resolution | Number of distinct pixels in each dimension that can be displayed. | 1,536 x 2,048 pixels | 1,536 x 2,048 pixels | Same |
| Horizontal Frequency | Rate at which the display scans horizontally. | 30 kHz to 130 kHz | 63 kHz to 96 kHz | Difference (not affecting safety/reliability) |
| Vertical Frequency | Rate at which the display refreshes the image vertically. | 56 Hz to 61 Hz | 50 Hz to 75 Hz | Difference (not affecting safety/reliability) |
| Input Video Signals | Types of video input connections supported. | DisplayPort x 2, DVI-IN x 1 | DisplayPort x 1, DVI-IN x 1 | Difference (not affecting safety/reliability) |
| Calibration Tool | Software used for display calibration. | PerfectLum 4.0 | PerfectLum 3.9 | Difference (updated version with UI/UX, OS, functional improvements, validated to ISO 62304) |
| Performance Items (Non-Clinical Test Summary) | ||||
| Spatial resolution | Measurements of information transfer from image data to luminance fields at different spatial frequencies, using TG18 QC Test Pattern. | Not explicitly quantified values, but "Same" implying comparable performance to predicate. | Assumed comparable to predicate | Same |
| Pixel defects | Measurements (count, types, locations) of pixel defects. | Not explicitly quantified values, but "Equivalent" implying acceptable limits comparable to predicate. | Assumed comparable to predicate | Equivalent |
| Artifacts | Evaluation for image artifacts such as ghosting and/or image sticking from displaying a fixed test pattern (5x5 mosaic pattern, 64 Gray / 127 Gray judgment). | Not explicitly quantified values, but "Same" implying comparable performance to predicate. | Assumed comparable to predicate | 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). | Not explicitly quantified values, but "Equivalent" implying acceptable limits comparable to predicate. | Assumed comparable to predicate | Equivalent |
| Luminance | Measurements of the maximum and minimum luminance the device outputs under recommended conditions. | Not explicitly quantified values, but "Same" implying comparable performance to predicate. | Assumed comparable to predicate | Same |
| Color tracking | Chromaticity at different luminance levels of primary colors and color gamut (e.g., CIE u'v'). | Not explicitly quantified values, but "Equivalent" implying acceptable limits comparable to predicate. | Assumed comparable to predicate | Equivalent |
| 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. | Not explicitly quantified values, but "Equivalent" implying acceptable limits comparable to predicate. | Assumed comparable to predicate | Equivalent |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical test set with a specific sample size. The testing performed was primarily non-clinical, comparing the technical characteristics and performance measures of the single proposed device (21HQ513D) against the predicate device (21HK512D).
- Sample Size: Not applicable for a typical clinical test set as this was a non-clinical comparison of device specifications.
- Data Provenance: The tests were conducted by LG Electronics Inc., which is based in South Korea. The nature of these tests (e.g., in-house lab testing) suggests the data provenance is internal to the manufacturer. The document doesn't specify if it's retrospective or prospective, but for non-clinical performance testing of a monitor, it would typically be prospective testing of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission is for a medical monitor, not an AI diagnostic algorithm. The "test set" here refers to the monitor's performance characteristics, not a dataset of medical images requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring ground truth adjudication.
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 MRMC study was done, as this device is a medical monitor, not an AI-assisted diagnostic tool. No AI component is described as being part of the device's functionality.
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 a standalone AI algorithm. It displays images for human practitioners.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" in this context refers to established engineering standards (e.g., IEC standards) and guidance documents (e.g., FDA's Display Devices for Diagnostic Radiology guidance) against which the monitor's physical and technical performance (spatial resolution, luminance, etc.) are measured.
8. The Sample Size for the Training Set
Not applicable. As noted, this is a medical monitor, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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