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510(k) Data Aggregation
(29 days)
The MDC212C2 Color displays are intended to be used for displaying of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers.
MDC212C2 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC 60601-1-1 certified equipment.
Diagnostic Imaging Color LCD Monitor, Model MDC212C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1600*1200p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided document is a 510(k) premarket notification for a medical display monitor, the NEC Diagnostic Imaging Color LCD Monitor, Model MDC212C2. It aims to demonstrate substantial equivalence to a legally marketed predicate device (MD210C3).
The document is not about an AI/ML medical device. It is a traditional medical device submission for a display monitor. As such, it does not describe a study involving human readers, AI assistance, or ground truth established by experts for diagnostic performance. The "acceptance criteria" and "study" described are related to the physical and technical performance of the monitor regarding display quality and safety, not diagnostic accuracy of an AI algorithm.
Therefore, many of the requested points regarding AI/ML device study design (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC study, standalone performance) are not applicable to the content of this document.
However, I can extract information related to the acceptance criteria for this specific device and the type of testing performed to prove it meets them.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and compliance with relevant performance and safety standards for medical displays. The "performance" is reported as technical specifications and adherence to these standards.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Predicate Device (MD210C3) Specification (Implicit Acceptance Target) | Subject Device (MDC212C2) Reported Performance | Assessment / Compliance |
|---|---|---|---|
| Classification | Class II/PGY | Class II/PGY | Meets |
| Intended Use | Displaying/viewing digital images for diagnosis by trained physicians (with caveats) | Displaying/viewing digital images for diagnosis by trained physicians (with caveats) | Meets (Identical) |
| Panel Size | 21.3" TFT Color LCD Monitor | 21.3" TFT Color LCD Monitor | Meets |
| Display Color | 1,073,741,824 | 1,073,741,824 | Meets |
| Luminance Calibration | Software | Software | Meets |
| Default Gamma | 1.8, 2.0, 2.2, DICOM part 14 | 1.8, 2.0, 2.2, DICOM part 14 | Meets |
| Power Input | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | Meets |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.270 mm x 0.270mm | Difference (Justified) |
| Viewing Angles | H:176, V:176 | H:89, V:89 | Difference (Justified) |
| Scanning Frequency (H, V) | 31.5-94.8, 126.3kHz, 50-85 Hz | 31.5-94.0 kHz, 50-85 Hz | Difference (Justified) |
| Native Resolutions | 2048 x 1536 | 1600 x 1200 | Difference (Justified) |
| Brightness | 400 cd/m2 calibrated, 800 cd/m2 Max. | 440 cd/m2 calibrated, 180 cd/m2 Max. | Difference (Justified) |
| Contrast Ratio | 1400 : 1 (typical) | 1500 : 1 (typical) | Difference (Justified) |
| DOT Clock | 214.3 MHz | 214.3 MHz | Meets |
| Input Signals/Terminals | DVI-D, Display Port | DVI-D (HDCP), Display Port (HDCP), 15pin Mini D-sub/VGA | Differences (Justified, additional inputs) |
| USB | No | USB Specification Revision 3.0 | Difference (Justified, added feature) |
| Active Display Size | Landscape: 433mm x325mm; Portrait: 325X433mm | Landscape: 432mm x 324 mm; Portrait: 324 X 432 mm | Minor Difference (Justified) |
| Viewable Image Size | 540 mm | 540 mm | Meets |
| Input Rating | 1.1-0.44A | 1.0 - 0.6 A | Difference (Justified) |
| Dimensions | Varied | Varied | Differences (Justified) |
| NET Weight | 11.8 kg | 8.0 kg | Differences (Justified) |
| Safety Standard Compl. | IEC 60601-1 (Implicit) | IEC 60601-1 | Meets |
| EMC Standard Compl. | IEC 60601-1-2 (Implicit) | IEC 60601-1-2 | Meets |
| Display Performance Compl. | AAPM TG 18 (Implicit) | AAPM TG 18 | Meets |
Note on "Differences": The document states that while there are differences in technological characteristics between the subject device and the predicate, "The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues." This is the core of a 510(k) submission: proving substantial equivalence despite differences.
Study Details (as applicable to a display monitor)
- Sample size used for the test set and the data provenance: Not applicable in the context of diagnostic image data. The "test set" here refers to the single subject device unit that underwent non-clinical testing. The provenance is the manufacturer's testing data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as in diagnostic labels is not established for a display monitor. The "ground truth" for the monitor's performance is adherence to technical specifications and industry standards like IEC 60601-1, IEC 60601-1-2, and AAPM TG 18.
- Adjudication method for the test set: Not applicable. Testing involves engineering and technical verification against established standards and specifications, not human adjudication of diagnostic findings.
- 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 display monitor, not an AI diagnostic tool, and no MRMC study was performed or required.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device revolves around the fulfillment of technical specifications and compliance with recognized medical device standards (e.g., IEC 60601-1 for safety, IEC 60601-1-2 for electromagnetic compatibility, and AAPM TG 18 for display performance).
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
In summary, the document provides evidence for the substantial equivalence of a medical display monitor to a predicate device, based on a comparison of technical specifications and adherence to relevant non-clinical performance and safety standards. It explicitly states, "The submission does not contain clinical data." and focuses on "non-clinical tests" and "design verification activities."
Ask a specific question about this device
(15 days)
The MD322C8 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display controllers. MD322C8 cannot be used for a life-support system. This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
Medical Display, MD322C8 is a 31.5" Color LCD monitor that displays image for medical use. It provides 3840*2160p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
This document is a 510(k) summary for the NEC Display Solutions MD322C8 31.5" Color LCD Monitor, intended for medical diagnostic imaging. The document primarily focuses on demonstrating substantial equivalence to a predicate device (MD210C3). Therefore, it does not contain a comprehensive description of acceptance criteria met through a standalone study with detailed clinical performance metrics, expert reviews, and sample sizes as typically seen for AI/ML-driven medical devices.
However, based on the provided text, I can extract information related to display performance testing and a comparison to a predicate device.
Here's the breakdown of the information requested, with observations based on the provided text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present quantitative acceptance criteria in a table format with corresponding quantitative device performance results for all tests. It lists specific "Display Testing" categories and then summarizes the outcome qualitatively.
| Acceptance Criteria Category (Implied by Test) | Reported Device Performance (Qualitative) |
|---|---|
| Display Reflection | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." (This statement applies to all listed display tests) |
| Luminance Response | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Luminance Uniformity | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Display Resolution | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Display Noise | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Veiling Glare | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Display Chromaticity | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Miscellaneous Tests | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| DICOM Conformance | The device conforms to "DICOM part 14" (stated in the comparison table indirectly and explicitly in the summary). Performance was within the acceptable range of DICOM part 14. |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in terms of clinical cases or patient data, as this is a display monitor. The "test set" would refer to the specific unit(s) of the MD322C8 monitor that underwent the listed "Display Testing." The document does not specify the number of monitors tested.
Data provenance is not applicable in the context of this device (a monitor). The tests are performance evaluations of the hardware itself.
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 this context, would involve objective measurements of display characteristics against established technical standards (like DICOM part 14), rather than expert interpretation of medical images. The testing relies on instrumentation and adherence to technical specifications.
4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for subjective human interpretations, especially in clinical studies or expert consensus. The testing of a display monitor against technical standards does not involve such human-based 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. This document pertains to a medical display monitor, not an AI/ML diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a display monitor and does not involve an algorithm with standalone performance. Its function is to accurately render images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the display tests would be established technical standards and specifications, such as DICOM Part 14 for grayscale display function and other industry standards for display performance metrics (e.g., luminance, chromaticity, resolution). These are objective, measurable standards, not medical ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is a display monitor, not a machine learning model, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
Ask a specific question about this device
(61 days)
The MD210C3 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display controllers.
MD210C3 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
Medical Display, MD210C3 is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance for a medical AI device.
The document is a 510(k) premarket notification for a diagnostic imaging LCD monitor (MD210C3), not an AI or algorithm-based device. Therefore, it discusses display specifications and comparisons to a predicate display, not AI performance metrics.
Specifically, the document does not contain any of the following information:
- Acceptance criteria for an AI algorithm expressed in terms of metrics like sensitivity, specificity, or AUC.
- Reported device performance (e.g., accuracy, recall) of an AI algorithm.
- Sample sizes for test sets used for AI model evaluation.
- Data provenance (country of origin, retrospective/prospective) for AI data.
- Number of experts or their qualifications for establishing ground truth for AI.
- Adjudication methods for an AI test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study information for AI.
- Standalone performance data for an AI algorithm.
- Type of ground truth used for AI (pathology, outcomes data).
- Sample size for training set of an AI model.
- How ground truth for the training set of an AI model was established.
The document primarily focuses on verifying that the new display (MD210C3) is substantially equivalent to a previously cleared predicate display (MD211C3) by comparing their physical and performance specifications as a display device. It mentions "Display Testing" with items like "Luminance Response" and "Display Resolution," and states "Test results showed minor differences between MD210C3 and MD211C3, however these differences are minor and were within the acceptable range of DICOM part 14." This refers to performance characteristics of a monitor, not an AI algorithm.
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