(23 days)
The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
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This document is an FDA 510(k) clearance letter for the Nio Color 3MP LED (MDNC-3321) Medical Flat Panel Display System. This is a display device, not an AI/ML algorithm or diagnostic device that performs independent analysis. Therefore, much of the requested information (like performance metrics, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies) is not applicable to this type of device.
The FDA clearance for a medical display system primarily focuses on its technical specifications, conformance to standards, and demonstration that it can accurately display medical images for human review. The "acceptance criteria" here refer to the performance specifications of the display itself, and the "study" would be a technical evaluation demonstrating that the display meets those specifications.
Here's an attempt to answer the applicable parts of your request based on the provided document, and explain why other parts are not relevant:
1. A table of acceptance criteria and the reported device performance
For a medical display, acceptance criteria typically involve electrical, optical, and mechanical performance standards (e.g., luminance, contrast, resolution, uniformity, color accuracy, stability, artifact absence). The provided 510(k) letter does not detail these specific criteria or their measured performance. Such information would be found in the full 510(k) submission, specifically in the sections describing design verification and validation. This letter only states that the device is "substantially equivalent" to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This device is a display, not a diagnostic algorithm that processes clinical data. Its "testing" involves technical measurements of the display's performance, not analysis of medical images in a clinical "test set."
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)
Not applicable. There is no "ground truth" established by medical experts for a display device in the way there would be for an AI diagnostic tool. The ground truth for a display is its ability to accurately render an image as intended by the input signal.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical adjudication is performed for a display device's performance.
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 is not an AI-powered device. An MRMC study is designed to assess the impact of a diagnostic aid (like AI) on physician performance. This device is a display, a fundamental piece of hardware for image viewing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a display, the "ground truth" would be related to its adherence to technical display standards and specifications, not clinical outcomes or expert diagnoses.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for a medical display (Nio Color 3MP LED). It indicates that the device is intended for displaying and viewing digital images (excluding digital mammography) for review by trained medical practitioners. The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device.
For a display device, the "acceptance criteria" and "study" would relate to demonstrating its technical performance characteristics (luminance, resolution, uniformity, color accuracy, stability, etc.) meet established medical display standards. This information is typically found in the technical documentation of the 510(k) submission itself, not in the clearance letter. The questions about clinical performance studies, expert ground truth, training sets, and AI assistance are not relevant to a medical display's regulatory clearance process as described in this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
Public Health Service
May 29, 2013
Barco N.V. % Mr. Lieven De Wandel Regulatory Affairs Officer 35 President Kennedypark B-8500 Kortrijk BELGIUM
Re: K131295
Trade/Device Name: Nio Color 3MP LED Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 21, 2013 Received: May 23, 2013
Dear Mr. De Wandel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm1.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131295
Device Name:
Indications for Use:
Nio Color 3MP LED (MDNC-3321)
The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.P.
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
' K131295 510(k)
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§ 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).