(114 days)
The Nio 5MP-M-21″ is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.
The MDNG-5121 BB is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.
Nio 5MP-M-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 BB is a 21.3" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is a softcopy QA software application for local calibration and QA control. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
The device consists of three components: One 5-megapixel flat panel display (MDNG-5121 BB). One 10-bit display controller (BarcoMed Nio board). NioWatch software. The flat panel display has a resolution of 2560x2048 pixels. It can be used in landscape and portrait mode. The BarcoMed Nio display controller board is an ultra-high speed board with a 8-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray. The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display and display controller information.
The provided 510(k) summary for the Barco Nio 5MP-M-21" (K062131) does not include a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/algorithm-based device.
This submission is for a medical display system, not an AI or diagnostic algorithm. The acceptance criteria and "study" described below are based on the information provided in the 510(k) where the manufacturer asserts substantial equivalence to a predicate device by comparing technical characteristics.
Here's the information structured to address your request, with clarifications where the information is not applicable or not present in a display system 510(k):
Acceptance Criteria and Device Performance (for a display system)
| Acceptance Criteria (Functionality/Characteristics) | Reported Device Performance (Nio 5MP-M-21") |
|---|---|
| Intended Use: Displaying digital images, including digital mammography, for review and analysis by trained medical practitioners. | Intended Use: "The Nio 5MP-M-21" is intended to be used in displaying digital images, including digital mammography, for review and analysis by trained medical practitioners." (Same as predicate) |
| Display Type: Flat panel display for medical viewing. | Display Type: MDNG-5121 BB is a 21.3" grayscale LCD display. |
| Resolution: Suitable for medical imaging, including mammography (predicate has 5MP). | Resolution: 2560x2048 pixels (5-megapixel). (Matches predicate) |
| Grayscale shades: High bit depth for medical imaging (predicate has 10-bit LUT). | Grayscale shades: 10-bit lookup table, providing 256 simultaneous shades of gray (from an 8-bit input). (Matches predicate) |
| Components: Display, controller board, QA software. | Components: MDNG-5121 BB (display), BarcoMed Nio (controller board), NioWatch (softcopy QA software). (Similar to predicate, with noted differences in I-Guard and software functionality but basic specs and functions are same). |
| Safety: Device does not come into contact with the patient; does not control life-sustaining devices. | Safety: Device does not come into contact with the patient. It does not control any life sustaining devices either. (Same as predicate) |
| Equivalence to Predicate: Substantially equivalent in technical characteristics, general function, application, and intended use; no effect on safety or efficacy due to differences. | Conclusion: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy." |
Study Information (as applicable to a medical display 510(k) for substantial equivalence):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This 510(k) is for a medical display system, not an AI/diagnostic algorithm that relies on a test set of patient data for performance evaluation. The "test" involves comparing the technical specifications and intended use of the new device against a legally marketed predicate device.
- Data Provenance: Not applicable in the context of patient data. The provenance pertains to the technical specifications and operational performance metrics of the device itself and its predicate.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" derived from expert consensus on medical images in the context of this 510(k). The evaluation is based on engineering specifications and regulatory comparison.
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Adjudication method for the test set:
- Not applicable. No test set requiring adjudication of diagnostic outcomes was used.
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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-assisted diagnostic device. The submission is for a display system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a display system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" equivalent in this type of submission is the established technical specifications and regulatory compliance of the predicate device, against which the new device's characteristics are compared for substantial equivalence.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
Summary of the "Study" (Substantial Equivalence Justification):
The "study" presented in this 510(k) is a comparison of technical characteristics between the proposed device (Nio 5MP-M-21") and its predicate device (Coronis 5MP). The manufacturer asserts that the devices are substantially equivalent, meaning the new device is as safe and effective as the predicate.
- Methodology: The manufacturer lists the technical components and specifications of the Nio 5MP-M-21" and directly compares them to those of the Coronis 5MP.
- Key Finding: The report states: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy."
- Differences noted: The primary difference is the absence of a built-in front sensor (I-Guard) in the Nio 5MP-M-21" display and lower functionality in its accompanying software application compared to the predicate. However, the basic specifications and functions relevant to displaying medical images are deemed the same.
In essence, the "study" is a technical comparison intended to demonstrate that the new device does not raise new questions of safety or effectiveness compared to a device already cleared for market. This is the standard approach for a medical display system 510(k) rather than a clinical performance study involving patient data.
§ 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).