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The Nurse's Assistant® O.R. Control System, 1.8 is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment.

The Nurse's Assistant® O.R. Control System, 1.8 is Indicated for use in an operating room for video assisted surgery during minimally invasive and traditional open procedures in all surgical specialities. The System is also used as an adjunct display of interventional techniques and provides teleconferencing capability through an optional interface.

The Nurse's Assistant® O.R. Control System, 1.8, is a modification of an existing device that is composed of off-the-shelf audio/video hardware components, proprietary software that runs on a non-Windows based operating system and a touch panel interface with an intuitive graphical user interface. The Nurse's Assistant® System 1.8 communicates with interconnected devices through standard data communication protocols which allows the adjustment of equipment settings and routing of audio/video signals from one location in the operating room.

The provided document is a 510(k) summary for the ConMed Integrated Systems Nurse's Assistant® O.R. Control System, 1.8. It focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics.

Crucially, this document does not contain information about acceptance criteria, device performance metrics, sample sizes, expert ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

The document explicitly states: "Clinical testing is not required for this device." This indicates that the regulatory submission was based on non-clinical performance (e.g., electrical safety, electromagnetic compatibility) and a comparison of technological characteristics and intended use to previously cleared devices, rather than a study involving patient data or human readers.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

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

• Not available. The document does not specify performance acceptance criteria or report device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy). Its focus is on demonstrating safety and efficacy through equivalence to predicate devices and compliance with non-clinical standards.

2. Sample size used for the test set and the data provenance:

• Not applicable. Clinical testing with a test set of data (patients/images) was not conducted or required for this device according to the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. As no clinical testing was performed, there was no need for experts to establish ground truth for a test set.

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

• Not applicable. No clinical test set was used.

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:

• No. The document explicitly states "Clinical testing is not required for this device." An MRMC study would fall under clinical testing. Furthermore, this device is an O.R. control system, not an AI-powered diagnostic, so the concept of human readers improving with AI assistance is not relevant to its function.

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

• No. The device is an O.R. Control System; it's not an "algorithm" in the sense of an AI diagnostic. The document focuses on hardware, proprietary software, and its ability to route signals and control medical equipment.

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

• Not applicable. No clinical ground truth data was used as clinical testing was not conducted. The assessment relied on a comparison of technical specifications and intended use against predicate devices.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that would typically be 'trained' on a dataset in the way a diagnostic AI is. Its software is proprietary, but its development would follow standard software engineering practices rather than machine learning training.

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

• Not applicable. As above, the concept of a 'training set' and 'ground truth' for training is not relevant to this type of device according to the provided documentation.

In summary, the provided FDA 510(k) summary focuses entirely on demonstrating substantial equivalence through non-clinical means (technical specifications, intended use comparison, and compliance with general safety standards), explicitly stating that clinical testing was not required for this device.

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