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The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route audio and video from multiple sources to multiple destinations.

The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.

The Nurse's Assistant® 1.7 O.R. Control System indicated for use with ConMed Linvatec IM3300 Endoscopic Camera, ConMed Linvatec LS7500 Xenon Light Source, ConMed Linvatec GS1002 40L Insufflator, ConMed Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp Energix WPS, Getinge ALM PrismaVision PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Camera, National Display Systems 15" & 18" Vector III and 19" & 32" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, ProVation™ procedure documentation device, Skytron Stellar Series Surgical Lights, optional Surgeon's Assistant™ accessory touch panel and an audio/video conferencing interface.

The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharynqoscopy, ear endoscopy and sinusoscopy.

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route audio and video from multiple sources to multiple destinations.

The provided text describes a 510(k) submission for a medical device called the "Nurse's Assistant® 1.7 O.R. Control System (1.7C)". This submission is for a modification to an existing device, and its primary purpose is to demonstrate substantial equivalence to previously marketed predicate devices.

Crucially, the document does NOT contain information about specific acceptance criteria or performance studies in the way one would typically find for a new artificial intelligence or diagnostic device. Instead, the "study" mentioned refers to the testing performed to demonstrate substantial equivalence to predicate devices rather than meeting specific performance metrics against a defined ground truth.

Here's an breakdown based on the information available:

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

• Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy). The implicit "acceptance criteria" is demonstrating substantial equivalence to predicate devices, meaning it operates in a similar manner and has similar safety and effectiveness.
• Reported Device Performance: The document states: "Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence to the predicate devices listed above." No specific numerical performance results are provided.

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 type of testing done is focused on the control system's functionality and safety, not on diagnostic performance with a test set of 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 surgical control system, not an AI or diagnostic tool that requires expert-established ground truth for performance evaluation in the typical sense. The 'ground truth' for such a device would relate to its functional specifications and safe operation, which are evaluated through engineering tests and adherence to standards.

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

• This information is not applicable/not provided for the same reasons as point 3.

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. This type of study is not relevant to a surgical control system. The device's purpose is to act as a centralized user interface for OR equipment, not to assist human readers in interpreting images or data.

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

• The device itself is a "computerized control system" designed for "operating room (OR) staff with a simple, centralized user interface". It is inherently a human-in-the-loop system. While functional tests of its components would be done standalone, the overall system's purpose is to be used by humans. The document does not detail specific standalone vs. human-in-the-loop performance studies as one would typically see for AI-driven diagnostic devices.

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

• For this type of device (a control system), the "ground truth" would be its adherence to engineering specifications, safety standards, and functional requirements. For example, does it correctly actuate the specified equipment settings? Does it route audio/video as intended? These are verified through engineering and functional testing, not typically through pathology or expert consensus on clinical cases.

8. The sample size for the training set

• This information is not provided and is generally not applicable to this type of device. The Nurse's Assistant 1.7 O.R. Control System is a hardware/software control system, not an AI model that undergoes "training" with a dataset in the machine learning sense.

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

• This information is not applicable for the reasons stated in point 8.

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