(52 days)
The Nio 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, excluding digital mammography, for review by trained medical practitioners.
The Nio 3MP 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.
The Nio 3MP device is a digital image display system
The Nio 3MP device consists of components to provide high resolution visualization of digital images.
The provided text is for a 510(k) premarket notification for a medical display system, not an AI-powered diagnostic device. Therefore, the typical acceptance criteria and study designs associated with AI performance (like sensitivity, specificity, MRMC studies, ground truth establishment with experts, etc.) are not applicable here.
The device in question, the "Nio 3MP Medical Flat Panel Display System," is a display system, and its acceptance criteria would primarily relate to image quality, display characteristics, and compliance with relevant medical display standards to ensure it's suitable for viewing digital medical images. The substantial equivalence determination is based on a comparison to a legally marketed predicate device (Nio 3MP Medical Grayscale Display System, K040041), implying that the new device meets similar performance and safety standards.
Below, I've outlined the information based on the context of a medical display system, rather than an AI diagnostic tool, as the original request's categories don't directly map to this type of device.
Acceptance Criteria and Study for Nio 3MP Medical Flat Panel Display System
Based on the provided 510(k) summary for the Barco Nio 3MP Medical Flat Panel Display System, the device is a digital image display system intended for viewing and displaying digital images (excluding digital mammography) for review by trained medical practitioners. The "study" in this context refers to the demonstration of substantial equivalence to a predicate device, as is typical for 510(k) clearances. Performance criteria for a medical display would typically include aspects like luminance, contrast ratio, uniformity, resolution, color accuracy (if applicable), and compliance with DICOM Part 14 Grayscale Standard Display Function.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list a table of acceptance criteria or detailed performance specifications for the Nio 3MP device. However, for a medical display system, typical "acceptance criteria" for regulatory clearance would revolve around demonstrating that the device meets established industry standards for medical image display and performs comparably to its predicate.
| Acceptance Criteria (Typical for Medical Displays) | Reported Device Performance (Inferred from 510(k) Substantial Equivalence and Industry Standards) |
|---|---|
| Image Quality Parameters: | |
| 1. Resolution: High enough to display diagnostic images (e.g., 3 Megapixel). | The device is named "Nio 3MP Medical Flat Panel Display System," directly indicating its 3-megapixel resolution. This meets the requirement for displaying high-resolution digital images. |
| 2. Luminance & Contrast: Sufficient brightness and contrast range for diagnostic interpretation. | Implied to be adequate for medical image review, comparable to the predicate device. Medical displays typically target a certain minimum calibrated luminance and contrast ratio. |
| 3. Uniformity: Consistent brightness and color across the entire display. | Implied to be compliant with industry standards for medical displays. |
| 4. Grayscale Standard Display Function (GSDF) Compliance (DICOM Part 14): Accurate rendering of grayscale images according to the DICOM standard (for grayscale models). | While the Nio 3MP Medical Grayscale Display System (K040041) is the predicate, this device is a "Flat Panel Display System." It's common for such systems to be calibrated to comply with DICOM Part 14 for accurate grayscale rendition, even if it has color capabilities, especially since its intended use is for reviewing digital images. This compliance would be a key part of demonstrating suitable performance for medical image review. |
| System Functionality: | |
| 5. Intended Use: Suitable for displaying and viewing digital images (excluding digital mammography) for review by trained medical practitioners. | The device's intended use statement directly matches this criterion. Its technological characteristics are described as providing "high resolution visualization of digital images," which aligns with this intent. |
| 6. Compatibility: Interoperability with medical imaging systems. | Inferred through its classification as a medical image display system. Generally, medical displays are designed to integrate with PACS (Picture Archiving and Communication Systems) and other medical workstations. |
| 7. Safety & EMC: Compliance with electrical safety and electromagnetic compatibility standards. | Essential for any medical device; demonstration of compliance with relevant national and international safety standards (e.g., IEC 60601-1) and EMC standards would be part of the 510(k) submission, even if not explicitly detailed in this summary. |
| 8. Performance Equivalence to Predicate: Demonstrates performance characteristics substantially equivalent to the legally marketed predicate device (Nio 3MP Medical Grayscale Display System, K040041). | The FDA's substantial equivalence determination (K042661) confirms that Barco NV successfully demonstrated that the Nio 3MP Medical Flat Panel Display System is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This implies that the new device meets or exceeds the performance benchmarks set by the predicate. |
Since this is a display system, not a diagnostic algorithm, the following points address the questions from the perspective of regulatory clearance for such a device. Many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC studies) are not applicable to the clearance pathway for a medical display.
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable in the context of a display system's 510(k) clearance. The "test set" for a display would refer to internal validation data for technical specifications (e.g., luminance, resolution, color accuracy), rather than a dataset of medical images for diagnostic performance evaluation. The 510(k) largely relies on demonstrating technical equivalence to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth, in the sense of expert-established diagnoses for medical images, is not relevant for the clearance of a medical display system itself. The system is a tool for viewing images, not for making an automated diagnosis or assessment.
4. Adjudication Method for the Test Set
- Not applicable. This concept relates to expert consensus on diagnostic interpretations for an algorithm's performance, which is not part of a display system's regulatory submission.
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. MRMC studies are specific to evaluating the clinical impact of an AI algorithm on human reader performance. This device is an image display, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a display monitor, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
- Not applicable. Ground truth (expert consensus, pathology, outcomes data) is for validating diagnostic claims of an algorithm or a new diagnostic method. For a display system, the "truth" is its adherence to technical specifications and industry standards for image presentation.
8. The Sample Size for the Training Set
- Not applicable. Display systems do not have "training sets" in the AI sense. Their development involves engineering and calibration to meet specified technical and regulatory requirements.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
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K042661 510(K) SUMMARY
NOV 1 9 2004
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| Manufacturer: | Barco NV BarcoviewTheodoor Sevenslaan 1068500 KortrijkBelgium |
|---|---|
| Submitted By: | Ferguson MedicalConsultant to Barco NV |
| Contact Information: | Phone: +32(0) 56 23 32 11FAX: +32(0) 56 23 3 74 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Image display system, medical imageworkstation, image monitor/display, and others |
| Proprietary Name: | Nio 3MP Medical Flat Panel Display System |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Nio 3MP Medical Grayscale Display System(K040041) |
| Device Description: | The Nio 3MP device is a digital image displaysystem |
| Intended Use: | The Nio 3MP Medical Flat Panel Display Systemis intended to be used in displaying andviewing digital images, excluding digitalmammography, for review by trained medicalpractitioners. |
| Technological Characteristics: | The Nio 3MP device consists of components toprovide high resolution visualization of digitalimages. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is an image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent FERGUSON MEDICAL 12200 Academy Road NE #931 ALBUQUERQUE NM 87111
Re: K042661 Trade/Device Name: Nio 3MP Medical Flat Panel Display System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: September 23, 2004 Received: October 4, 2004
· Dear Mr. Ferguson:
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.
M your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 your 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); good manufacturing practice requirements as set forth in the quality systems (QS) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known):
Device Name: Nio 3MP Medical Flat Panel Display System
Indications For Use:
The Nio 3MP 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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Seymore
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number
Prescription Use _ XX (Per 21 CFR 801.109)
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Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
§ 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).