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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 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" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, and ProVation™ procedure documentation device.

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, nasopharyngoscopy, 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 video from multiple sources to multiple destinations.

This 510(k) summary describes a modification to an existing device, the Nurse's Assistant® 1.7 O.R. Control System, and focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against acceptance criteria. Therefore, many of the requested categories related to a de novo device study or AI-specific performance evaluation cannot be directly extracted from the provided text.

Here is an analysis based on the available information:

Description of the Device and Study Focus:

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system designed to provide OR staff with a centralized user interface for activating, adjusting, and monitoring certain equipment settings, and for routing video within the OR. The submission (K052740) describes a modification to an existing Nurse's Assistant® 1.7 O.R. Control System (predicate K050829) and also references the HERMES O.R. Control Center (predicate K030240). The primary goal of this submission is to demonstrate substantial equivalence to these predicate devices.

This means the "study" described is primarily a comparative effectiveness study against established predicate devices, focusing on demonstrating that the modified device has the same intended use, similar indications for use, and equivalent technological characteristics, safety, effectiveness, and performance. This is not a standalone performance study in the typical sense of establishing de novo performance metrics for a novel device. There is no indication of AI involvement in this device from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

As this K052740 submission is for a modification to an already cleared device and relies on substantial equivalence, explicit "acceptance criteria" for a new device's performance are not detailed in the provided text. Instead, the "acceptance criteria" implicitly revolve around demonstrating equivalence to the predicate devices in terms of:

Note: The document explicitly states "Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence." However, the specific details or results of these "tests" are not provided in the submitted summary.

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

This information is not provided in the given text. As the submission is for a modification seeking substantial equivalence, it's likely the "tests" performed were focused on verifying the new components or software changes maintained compatibility and functionality consistent with the predicate, rather than an extensive new clinical trial with a large test set. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

This information is not provided and is generally not applicable to this type of 510(k) submission for a control system modification focusing on substantial equivalence. The "ground truth" here would be the established safe and effective operation of the predicate devices.

4. Adjudication Method for the Test Set

This information is not provided and is not typically relevant for a substantial equivalence submission for a modification to a control system.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done based on the provided document.
• AI is not mentioned in the context of this device or study. The device is described as a "computerized control system," which predates widespread clinical AI applications. Therefore, there is no discussion of human readers improving with or without AI assistance.

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

• This device is a "computerized control system" designed to provide a "user interface" for "OR staff." It inherently involves human interaction and is not an algorithm-only standalone device in the sense of an AI-powered diagnostic tool.
• The nature of the device (a control system for OR equipment) means its performance is inextricably linked to human operation and integration within the surgical environment.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is implicitly the established safety, effectiveness, and performance of the legally marketed predicate devices (K050829 and K030240). The tests performed were to ensure the modified device maintained this established performance. There is no mention of pathology, outcomes data, or expert consensus being used to establish a new ground truth for this modification.

8. The Sample Size for the Training Set

This information is not provided and is irrelevant for this type of device and submission. This is not a machine learning or AI-driven device that requires a training set in that context.

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

This information is not provided and is irrelevant for this type of device and submission.

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The Nurse's Assistant® 1.7 is intended to be used to route video from multiple sources to multiple destinations, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating parameters of video displays, analog or digital recording, communication and playback equipment, endoscopic cameras, endoscopic light sources, surgical lamps, observation cameras, surgical cameras and operating room lights.

The Nurse's Assistant® 1.7 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 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, nasopharyngoscopy, ear endoscopy and sinusoscopy.

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that provides operating room (OR) staff with a simple touch panel interface from which to activate, adjust and monitor certain settings of equipment located in the OR.

The provided text is a 510(k) premarket notification for the Nurse's Assistant® 1.7 O.R. Control System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove safety and effectiveness from scratch. Therefore, the information typically requested in your query (e.g., sample sizes, ground truth establishment, MRMC studies, specific acceptance criteria with performance metrics) is not present in this document, as it is not required for a 510(k) submission that demonstrates equivalence to existing predicate devices.

Instead, the document focuses on comparing the new device's intended use, indications for use, and technological characteristics to those of predicate devices. The "study" in this context is the comparison itself, which concludes that the Nurse's Assistant® 1.7 is substantially equivalent.

Here's an organized breakdown based on the available information, with explanations for what is not present:

Acceptance Criteria and Study for Nurse's Assistant® 1.7 O.R. Control System

Device: Nurse's Assistant® 1.7 O.R. Control System

Approach: This 510(k) submission leverages the concept of substantial equivalence to predicate devices rather than proving de novo safety and effectiveness through clinical trials with specific performance metrics. Therefore, the "acceptance criteria" and "study" are framed around demonstrating equivalence to already approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a 510(k) submission, the "acceptance criteria" are primarily established by the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices. Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision figures) and numerical acceptance thresholds for these metrics are typically not provided in a 510(k) summary when equivalence is established through comparison of design and intended use, rather than de novo performance testing. The "reported performance" here refers to the conclusion of equivalence based on the comparison and any verification/validation testing performed.

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

• Sample Size: Not applicable/Not mentioned. The document does not describe specific patient or image test sets in the typical sense of a clinical performance study. The "tests performed" refer to verification and validation activities to confirm the device operates as designed and is equivalent to predicates.
• Data Provenance: Not applicable/Not mentioned. The document does not refer to clinical data (e.g., from specific countries, retrospective/prospective studies) for performance evaluation.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable/Not mentioned. The determination of substantial equivalence does not involve establishing ground truth from experts for a diagnostic output.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. No clinical test set is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document does not describe an MRMC study.
• Effect Size: Not applicable. An MRMC study was not conducted, so no effect size for human reader improvement with AI assistance is reported. This device is an OR control system, not a diagnostic AI tool.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: No. This device is an O.R. Control System; it's an integrated hardware/software system to manage other medical equipment, not a standalone algorithm in the typical AI sense that would have an "algorithm only" performance study. The "tests performed" refer to engineering and functional verification to ensure the system operates correctly.

7. Type of Ground Truth Used

• Not applicable/Not mentioned. The concept of "ground truth" (e.g., pathology, outcomes data) is not relevant to this 510(k) submission, which focuses on functional equivalence of an OR control system, not diagnostic accuracy.

8. Sample Size for the Training Set

• Not applicable/Not mentioned. This device is a control system, not a machine learning model that would typically have a "training set" of data in the context of AI.

9. How Ground Truth for the Training Set Was Established

• Not applicable/Not mentioned. As there is no described training set, there is no ground truth establishment for it.

Conclusion from the Document:

The Nurse's Assistant® 1.7 O.R. Control System gained clearance based on demonstrating substantial equivalence to three predicate devices: Val Med Nurse's Assistant O.R. Control System (K010754), Olympus Integrated Endosurgery System EndoALPHA (K981993), and Karl Storz OR1 (KSEA SCB-ACC) (K023704). The "study" proving it meets "acceptance criteria" is the comprehensive comparison of its intended use, indications for use, and technological characteristics to these legally marketed devices, concluding that it is as safe and effective.

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