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The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.

The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment,

The Barco Nexxis OR system allows control and selection of these signals from a central point.

The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,

The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.

The Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The Nexxis OR can consist of any possible combination of the Nexxis encoders/decoders that transfer video signals from various available devices to one or more output devices (displays). Additionally the Nexxis components can transfer audio signals and USB signals. The USB communication is intended only for keyboard and mouse control and control signals for non-medical room equipment. The selection of sources and output devices is done by control software (NMS API). The Nexxis OR system can also contain, optionally, the MNC-180 compositor device, a MDSC-8258 MNA display and/or the touch user interface MUIP-2112. The Nexxis OR system may now consist of any combination of the following components: a) Nexxis OR components (Medical network adaptors) b) Nexxis Compositor with NCS composition software (MNC-180) c) Nexxis Management Suite (NMS). d) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.(optional) e) touch user interface MUIP-2112 (optional) f) Cables g) Documentation

The provided document is a 510(k) premarket notification for the Barco Nexxis OR system, which is a video distribution solution for operating rooms. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of diagnostic performance.

Therefore, many of the requested elements for a diagnostic device's acceptance criteria and study cannot be extracted from this document.

Here's what can be gathered and what cannot:

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

The document does not provide a table of acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, the "acceptance criteria" can be inferred as demonstration of similar characteristics in terms of safety and effectiveness compared to the 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)

This information is not provided in the document. The testing described ("Display bench tests," "Display validation tests," "Nexxis OR qualification tests," "System tests") appears to be engineering and system validation rather than clinical performance testing with a "test set" of medical images or patient data.

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 applicable/not provided. The device is a video distribution system, not a diagnostic algorithm that relies on expert interpretation of output.

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

This information is not applicable/not provided.

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 applicable/not provided. This is not a diagnostic device with an AI component for image interpretation.

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

This information is not applicable/not provided. This is a system for distributing video signals, not a standalone diagnostic algorithm.

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

This information is not applicable/not provided. Ground truth in a clinical sense would not be relevant for the device itself, though the medical images it transmits would have their own ground truth established outside the scope of this device.

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI/ML device that requires a training set.

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

This information is not applicable/not provided.

Summary based on information provided in the document:

The Barco Nexxis OR system is a medical video distribution system. The study to demonstrate its performance and meet acceptance criteria primarily consisted of bench tests and system qualification tests. These tests aimed to show that the device has similar characteristics to its predicate device (Nexxis OR cleared under K170537) and did not reveal new issues of safety and effectiveness. The document explicitly states that "Animal or clinical testing have not been performed," indicating that the "study" was not a clinical trial in the traditional sense, but rather engineering and functional validation.

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The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.
The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment,
The Barco Nexxis OR system allows control and selection of these signals from a central point.
The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,
The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.

The generic Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The generic nexxis OR can consist of any possible combination of the nexxis encoders/decoders that transfer video signals from various available devices to one or more output devices (displays). Additionally the nexxis components can transfer audio signals and USB signals. The USB communication is intended only for keyboard and mouse control and control signals for non-medical room equipment. The selection of sources and output devices is done by control software (NMS API). The generic Nexxis OR system can also contain, optionally, the MNC-180 compositor device and/or a MDSC-8258 MNA display. The Nexxis OR system may consist of any combination of the following components: a) Nexxis OR components (MNA adapters (encoders and decoders), NMS management SW, network switches, SFP+ modules) b) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA. (optional) c) Nexxis Compositor (MNC-180) (optional) d) Cables e) Documentation

The provided document describes the FDA 510(k) premarket notification for the Barco Nexxis OR system, a device for A/V signal and medical image distribution in operating rooms. The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions.

Based on the provided text, here's an analysis regarding acceptance criteria and the study that proves the device meets them:

Core Finding: This document does not describe a study that establishes detection or diagnostic performance metrics against a clinical ground truth for the Nexxis OR system. Instead, it describes bench testing to demonstrate the device meets specified performance characteristics compared to a predicate device. The acceptance criteria and "studies" are focused on engineering and functional equivalence rather than clinical diagnostic accuracy, as this is a video distribution system, not a diagnostic imaging device.

Acceptance Criteria and Reported Device Performance

The document states:
"The tests showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and effectiveness."

While specific quantitative acceptance criteria are not explicitly detailed in a table, the document lists the types of tests performed:

The overall acceptance criterion is that the Nexxis OR system performs comparably or better than the predicate device without introducing new safety or effectiveness concerns, specifically for its function of distributing A/V signals and medical images.

Study Details (as inferable from the document)

Given that this is a video distribution system rather than a diagnostic AI or imaging device, the typical clinical study parameters requested (e.g., sample size for test set with ground truth, expert readers, MRMC, standalone performance) are not applicable in the context of this 510(k) submission. The "study" here refers to engineering and system performance testing.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" would be the configurations and operational scenarios of the Nexxis OR system itself. The document does not specify the number of test cases or images used; it refers to "bench tests," "display validation tests," "Nexxis OR qualification tests," and "system tests."
   • Data Provenance: Not applicable. The device handles existing clinical image data, but it does not generate or interpret new diagnostic data. The focus is on the faithful transmission and display of signals.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. Ground truth in this context would relate to the technical specifications and fidelity of A/V signal transmission, not clinical diagnoses. These tests would have been performed by engineers or qualified technical personnel, verifying signal integrity, latency, resolution, etc., against predefined technical standards.

3. Adjudication Method for the Test Set:

   • Not applicable. There is no "adjudication" in the clinical sense mentioned, as no human readers are interpreting diagnostic outcomes. Technical test results would be compared against engineering specifications.

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:

   • No, not done. This type of study is for diagnostic or AI-assisted devices that impact human reader performance. The Nexxis OR system is a signal distribution system, not an AI or diagnostic aid.

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

   • Not applicable. The device itself is a "standalone" system in its function (i.e., it performs its function of signal distribution independently). The concept of "standalone performance" for an algorithm's diagnostic accuracy is not relevant here. The bench and system tests would assess its technical performance.

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

   • The "ground truth" would be engineering specifications and technical standards for A/V signal quality, latency, resolution, and system functionality. For example, testing might involve comparing displayed image quality to source image quality, measuring signal latency, or verifying the correct routing of signals according to control inputs. This is not a clinical ground truth for diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable. The Nexxis OR system is a hardware and software system for signal distribution, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No machine learning training set is involved.

Ask a specific question about this device

The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.

The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment.

The Barco Nexxis OR system allows control and selection of these signals from a central point.

The Barco Nexxis OR system is not intended to be used for remote or robotically-assisted surgery.

The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.

The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room. The system also allows for the transfer, selection, and distribution of human interface signals and control signals of non-medical room equipment, with control and selection from a central point.

This document is an FDA 510(k) clearance letter for the Barco Nexxis OR system. It determines substantial equivalence for the device based on its intended use, which is for the transfer, selection, and distribution of A/V signals and medical images from various instruments in a medical procedure laboratory or operating room, and for the transfer, selection, and distribution of human interface and control signals of non-medical room equipment, all controlled from a central point.

The document does not contain information about:

• Acceptance criteria and reported device performance (in a table or otherwise)
• Sample size used for the test set or data provenance
• Number of experts and their qualifications used to establish ground truth
• Adjudication method
• Multi-reader, multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document is a regulatory clearance and details the administrative aspects of its approval, not the technical validation or study results that would typically include the requested information.

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