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The Nio 5MP (MDNG-6121) display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

Nio 5MP (MDNG-6121) display

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the Nio 5MP (MDNG-6121) display. This document does not contain information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or a more detailed technical submission.

Therefore, I cannot extract the requested information from this document. It primarily serves to state that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices for its indicated use.

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The Nio 5MP-21″ is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. The Nio 5MP-21", containing the display MDNG-5121 CB, the software NioWatch and the graphic board BarcoMed Nio, will be marketed as separate device.

Nio 5MP-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 CB 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.

This submission, K062621, describes the Barco Nio 5MP-21" display system, which is intended for displaying digital images, including digital mammography, for review and analysis by trained medical practitioners. The document states that the device is substantially equivalent to existing predicate devices (Coronis 5MP and MFGD 5421). The submission does not provide specific acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/CADe device.

Instead, this 510(k) summary focuses on demonstrating that the new device has "substantially equivalent" technological characteristics, general function, application, and intended use as its predicate devices, and that any differences do not affect safety or efficacy. This is a common approach for display systems where the primary concern is the accurate and consistent rendering of medical images, rather than algorithmic detection or diagnosis.

Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/CADe systems, is not applicable to this 510(k) submission for a medical display system. The "study" here is essentially a technical comparison and declaration of substantial equivalence to a legally marketed predicate device.

However, based on the information provided, here's how some of your questions can be addressed in the context of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit "acceptance criteria" and "reported device performance" in the context of clinical accuracy (like sensitivity, specificity, AUC) are not provided for this display system. The acceptance criteria for a display system are typically related to its technical specifications matching or being equivalent to the predicate, ensuring it accurately displays images without introducing errors.

• "The Barco MDNG-5121 CB is substantially equivalent to the predicate device, MFGD 5421."
• "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use." |

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 is a medical display system, not an AI/CADe device that processes patient data for diagnostic output requiring a "test set" of images or patient data. The "testing" involves technical verification against specifications and comparison to predicate devices, not a clinical data 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. See point 2. Ground truth establishment with experts is relevant for diagnostic or AI/CADe devices, not for a display system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 2. No test set requiring expert adjudication is mentioned.

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 a display system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This device does not have an algorithm that performs a standalone diagnostic or assistive function in the absence of a human reader.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. For a display system, the "ground truth" would relate to its technical performance (e.g., luminance, uniformity, resolution accuracy) against industry standards or the manufacturer's specifications, not clinical outcomes or pathology. This document does not detail specific technical performance testing, but rather relies on substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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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)

Study Information (as applicable to a medical display 510(k) for substantial equivalence):

1. 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.

2. 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.

3. Adjudication method for the test set:

   • Not applicable. No test set requiring adjudication of diagnostic outcomes was used.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that would require a training set.

8. 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.

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The Nio 5MP 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 5MP 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 5MP device is a digital image display system.

The Nio 5MP device consists of components to provide high resolution visualization of digital images.

The provided text is a 510(k) summary for a medical flat panel display system (Nio 5MP) and its FDA clearance letter. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically understood for AI/algorithm-based medical devices.

Instead, this document focuses on establishing substantial equivalence for a hardware display system based on its intended use and technological characteristics compared to a predicate device.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study that proves the device meets those criteria for this particular submission. The device described is a display system, not an AI/algorithm producing diagnostic outputs for which performance metrics like sensitivity, specificity, or AUC would be established through clinical studies.

The information provided confirms:

• Device Name: Nio 5MP Medical Flat Panel Display System
• Intended Use: "displaying and viewing digital images, excluding digital mammography, for review by trained medical practitioners."
• Classification: Image processing system, Class II, Product Code 90 LLZ.
• Predicate Device: Nio 5MP Medical Grayscale Display System (K040040)

Without a study described in the provided text, I cannot provide details on the following:

1. A table of acceptance criteria and the reported device performance: Not applicable.
2. Sample sized used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Nio 5MP Medical Grayscale 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 5MP device is a digital image display system. The Barco Nio 5MP device consists of components to provide high resolution visualization of digital images.

This is a 510(k) premarket notification for a medical device: Barco Nio 5MP Medical Grayscale Display System. As such, the submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and performance metrics typically seen for novel diagnostic algorithms.

Here's an analysis based on the provided text, highlighting the information that is present and noting what is absent:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the given text. A 510(k) submission for a display system typically focuses on meeting technical specifications (e.g., luminance, contrast, resolution, DICOM conformance) rather than clinical performance metrics like sensitivity or specificity for a diagnostic task. The document states that the device provides "high resolution visualization of digital images," implying it meets general display standards, but no specific performance criteria or a table are presented.

2. Sample size 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. Since this is a display system, a "test set" in the context of diagnostic accuracy studies (like those for AI algorithms) is not applicable. The evaluation for a display system would involve technical performance tests and possibly human factor usability assessments, but not a dataset of medical images for diagnostic performance evaluation of the display itself.

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. As explained above, the concept of "ground truth" for diagnostic accuracy is not relevant for a medical display system in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Not applicable for a display system.

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

This information is not provided. MRMC studies are used for evaluating diagnostic performance, often for AI algorithms or new imaging modalities. This device is a display system, not an AI diagnostic tool, so such a study would not be performed for its clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. Not applicable, as this is a display system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided. Not applicable for a display system.

8. The sample size for the training set

This information is not provided. Not applicable, as this is a display system, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

This information is not provided. Not applicable, as this is a display system, not an AI algorithm.

Summary of what is available from the document:

The provided document is a 510(k) Summary for a medical display system. Its primary purpose is to demonstrate substantial equivalence to an already legally marketed predicate device (Barco NV Display Systems Coronis 3MP Medical Flat Panel Display System, K013922).

• Device Description: The Nio 5MP device is a digital image display system consisting of components to provide high-resolution visualization of digital images.
• Intended Use: "The Barco Nio 5MP Display System is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners."
• Basis for Clearance: The FDA's decision to clear the device is based on its determination of "substantial equivalence" to the predicate device, meaning it has the same intended use and similar technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. The document itself does not contain detailed studies with acceptance criteria for clinical performance but implies that the device meets technical standards necessary for medical image review.

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