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510(k) Data Aggregation
(29 days)
21HQ513D, 32HL512D, 31HN713D, 32HQ713D
21HQ513D, 32HL512D: 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.
31HN713D, 32HO713D: 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.
The provided document describes the acceptance criteria and the results of the study for the medical monitors 21HQ513D, 32HL512D, 31HN713D, and 32HQ713D.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
The document refers to the "performance items suggested in the FDA guidance 'Display Devices for Diagnostic Radiology'" as the acceptance criteria. The performance for each measurement is uniformly reported as "Pass" for the tested items.
| Measurements | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance |
|---|---|---|
| a. Spatial resolution | Meet FDA guidance standards | Pass |
| b. Pixel defects | Meet FDA guidance standards | Pass |
| c. Artifacts | Meet FDA guidance standards | Pass |
| d. Temporal response | Meet FDA guidance standards | Pass |
| e. Luminance | Meet FDA guidance standards | Pass |
| f. Conformance to a grayscale-to-luminance function | Meet FDA guidance standards | Pass |
| g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| h. Luminance uniformity or Mura test | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| i. Stability of luminance and chromaticity response with temperature and time of operation (on-time) | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| j. Spatial noise | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| k. Reflection coefficient | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| l. Veiling glare or small-spot contrast | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| m. Color tracking | Meet FDA guidance standards | Pass |
| n. Gray tracking | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
Note: The "N/A" for certain measurements for models 21HQ513D and 32HL512D might indicate that these tests were not applicable or not performed for these specific models, possibly due to their differing indications for use (not intended for mammography, unlike 31HN713D and 32HQ713D). The document does not explicitly state the acceptance numerical values for each criterion but implies compliance with the FDA guidance "Display Devices for Diagnostic Radiology".
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or images. The study described is a non-clinical bench test on the display devices themselves. The sample size for the test set would be the number of devices tested, which is implied to be one of each model (21HQ513D, 32HL512D, 31HN713D, and 32HQ713D). The data provenance is not applicable in the typical sense of clinical data, as it's a technical performance test of hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study is a non-clinical bench test of display performance against predefined technical standards and FDA guidance, not a study involving expert interpretation of medical images.
4. Adjudication method for the test set
This information is not applicable. There was no expert adjudication process as it was a technical performance test.
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 comparative effectiveness study was done. The device is a medical monitor, not an AI-powered diagnostic tool. The document explicitly states: "No clinical studies were considered necessary and performed."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical monitor, not an algorithm or AI system. The study focused on the technical performance of the monitors.
7. The type of ground truth used
For the bench test, the ground truth was based on the performance items suggested in the FDA guidance "Display Devices for Diagnostic Radiology." This refers to quantifiable technical specifications and standards for medical image displays.
8. The sample size for the training set
This is not applicable. The device is a medical monitor, not a machine learning algorithm that requires a training set. The software components underwent validation according to IEC 62304.
9. How the ground truth for the training set was established
This is not applicable, as there was no training set for an AI algorithm. The validation of the software was done according to IEC 62304, which involves verifying the software against its design specifications and requirements.
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(21 days)
21HQ513D
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 document is a 510(k) summary for a medical monitor (21HQ513D) and does not detail the acceptance criteria and study proving device performance as would be expected for an AI/ML-driven medical device. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.
However, it does include a "Bench Test – Performance Test Report" which lists various measurements and their test results. While not a study proving the device meets AI/ML acceptance criteria, it demonstrates the physical display characteristics meet predefined criteria.
Here's an interpretation based only on the provided text, focusing on the nearest relevant information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for each measurement, but rather indicates a "Pass" or "N/A" for each as well as a general statement that "All display characteristics of the 21HQ513D have met the pre-defined criteria."
| Measurements | Test Result | Acceptance Criteria (Implied) |
|---|---|---|
| a. Spatial resolution | Pass | Met pre-defined criteria |
| b. Pixel defects | Pass | Met pre-defined criteria |
| c. Artifacts | Pass | Met pre-defined criteria |
| d. Temporal response | Pass | Met pre-defined criteria |
| e. Luminance | Pass | Met pre-defined criteria |
| f. Conformance to a grayscale-to-luminance function | Pass | Met pre-defined criteria |
| g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners | N/A | Not applicable/measured |
| h. Luminance uniformity or Mura test | N/A | Not applicable/measured |
| i. Stability of luminance and chromaticity response with temperature and time of operation (on-time) | N/A | Not applicable/measured |
| j. Spatial noise | N/A | Not applicable/measured |
| k. Reflection coefficient | N/A | Not applicable/measured |
| l. Veiling glare or small-spot contrast | N/A | Not applicable/measured |
| m. Color tracking | Pass | Met pre-defined criteria |
| n. Gray tracking | Pass | Met pre-defined criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests appear to be bench tests conducted on the device itself, rather than studies involving medical images or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The tests seem to be objective measurements based on established standards (e.g., "FDA guidance 'Display Devices for Diagnostic Radiology'").
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 such study was performed or described. The device is a medical monitor, not an AI-driven diagnostic aid. The document explicitly states: "No clinical studies were considered necessary and performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The performance tests are based on physical characteristics and compliance with industry standards and FDA guidance for display devices, not on medical ground truth.
8. The sample size for the training set
Not applicable. This device is a medical monitor, not an AI/ML diagnostic algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(134 days)
21HQ513D
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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