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The kit is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.

The NIVR58-T kit is a set of devices bundled together by Barco as a system, to be used in a larger system of a customer.

The system that Barco composes, consists of the following devices:
a) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.
b) Nexxis Compositor (MNC-180)
c) Nexxis OR components
d) A control unit panel PC (tablet PC): Barco MTPP-0212 (other name: Proscribe) with control user interface.
e) Cables
f) Documentation

The NIVR58-T kit is the visualization part in an operating room or cathlab. The video sources from different medical devices in the OR are connected to the NIVR58-T kit. The NIVR58-T kit makes a composition of the video signals and sends the composition signals to the 58-inch display.

The selection of the video sources that have to be displayed and the layout of the composition is done by the Nexxis OR component and controlled by the control unit MTTP 0212, on which a Graphical User Interface is installed.

The provided text is a 510(k) premarket notification for the Barco NIVR58-T Kit, a medical device intended to integrate video from various instruments into a single display for healthcare professionals, primarily in operating rooms or cath labs.

Based on the information provided in the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Core Finding: The document does NOT contain information regarding acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML or diagnostic performance.

Instead, this 510(k) focuses on demonstrating substantial equivalence to a previously cleared predicate device (SIVR56-T, K133994). The "studies" mentioned are bench tests to confirm that the new device has similar or superior characteristics without introducing new safety or effectiveness issues.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission, as it's not a diagnostic AI/ML device requiring clinical performance validation in the way implied by the question.

However, I can extract and present the relevant information that is present, addressing the spirit of the question within the context of a substantial equivalence claim for a display and video integration system.

Overview from the Document:

The NIVR58-T kit is a video integration and display system for medical use, specifically designed to combine video streams from various medical instruments onto a single large-screen display in an operating room or cath lab. The regulatory pathway chosen is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence of a medical display and video integration system, the "acceptance criteria" are not performance metrics like sensitivity/specificity for a diagnostic AI. Instead, they relate to characteristics being similar or superior to the predicate device and not introducing new safety/effectiveness issues.

• Display validation tests
• Nexxis OR qualification tests
• System tests
  These tests are implicitly the "study" proving the device meets the characteristics. The document does not provide numerical results from these tests, only the conclusion that they showed similar or superior characteristics. |
  | Safety and Performance: No new issues of safety and effectiveness are revealed. | Met: "Bench testing... did not reveal new issues of safety and effectiveness." This is a qualitative assessment based on the bench testing. The document explicitly states: "Animal or clinical testing have not been performed." This is common for devices demonstrating substantial equivalence where bench testing sufficiently addresses the changes. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in terms of clinical cases or patient data. The "test set" for this device consists of the physical device components themselves undergoing bench testing. The testing is a series of engineering and performance tests on the hardware and software, not a study of patient data.
• Data Provenance: Not applicable in the sense of patient data. The tests were performed on the device components and system as engineered and manufactured by Barco N.V. (located in Kortrijk, Belgium, as indicated by the address). The tests are internal validation tests by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable: For this type of device (medical display and video integrator), "ground truth" as typically understood in AI/ML or diagnostic studies (e.g., expert labels on images) is not relevant. The "ground truth" for the bench tests would be the engineering specifications and performance standards of the device. These are established by the manufacturer's engineers and quality assurance teams, not by medical experts interpreting data.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements in human expert labeling of data, especially in diagnostic tasks. Since the "test set" involves bench testing of hardware/software against engineering specifications, such adjudication is not performed. Test failures would be investigated and resolved by engineering and quality teams.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: The document explicitly states: "Animal or clinical testing have not been performed." An MRMC study is a type of clinical study involving multiple human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This was not required or performed for this 510(k).

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

• Not Applicable in the traditional sense of a diagnostic algorithm: While the device's components (e.g., Nexxis Compositor MNC-180 for video composition) perform algorithmic functions, this is not a diagnostic AI algorithm that operates "standalone" to produce a medical finding. Its "standalone" performance would be its ability to correctly process and display video signals according to specifications, which is covered by the bench tests.

7. The Type of Ground Truth Used

• Engineering Specifications and Performance Standards: The "ground truth" for proving substantial equivalence here relies on demonstrating that the device's technical specifications and measured performance (e.g., display quality, video processing capability, signal latency) meet or exceed those of the predicate device, and that it reliably performs its intended function of video integration and display. This is verified through objective bench testing.

8. The Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set" of data for learning. Its functionality is hard-coded or configured based on engineering design.

9. How the Ground Truth for the Training Set was Established

• Not Applicable: As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

In summary, the provided document describes a 510(k) submission for a non-AI/diagnostic medical device (a display and video integration system). The "acceptance criteria" and "studies" are framed within the context of demonstrating substantial equivalence to a predicate device through engineering bench testing rather than clinical performance studies using patient data or AI/ML algorithms.

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