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The NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.

Indications for NIM 3.0 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities

Indications for Spinal procedures which may use NIM 3.0 EMG monitoring include:

Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures, and Thoracic Surgical Procedures.

NIM 3.0 is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying electrical stimulus for evoked responses. The monitoring console uses both video and audio output. Responses monitored with the device may originate from operator applied electrical stimulus or from direct or indirect mechanical stimulus occurring during the course of the surgery.

This is an FDA 510(k) summary for the Medtronic Nerve Integrity Monitor 3.0. A 510(k) summary is submitted to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed performance data from a clinical study proving specific acceptance criteria.

Based on the provided text, a formal study with detailed acceptance criteria and reported device performance metrics in the format requested was not provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting the results of a primary clinical study against specific, quantified acceptance criteria.

The following information is what can be extracted or inferred from the provided text, along with what is explicitly not present.

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

• Acceptance Criteria: Not explicitly stated or quantified in this 510(k) summary. The summary focuses on demonstrating substantial equivalence based on indications, design, technology, functions, and principle of operation to predicate devices (Medtronic NIM Spine K031510 and NIM PRS K024316).
• Reported Device Performance: Not provided in terms of quantitative metrics against specific acceptance criteria. The narrative indicates the device's capabilities (locating and identifying nerves, monitoring responses from applied electrical or mechanical stimulus), but no performance outcomes (e.g., sensitivity, specificity, accuracy, or other quantifiable measures) from a study are included.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not provided.
• Data Provenance: A specific test set or study data is not described.

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)

• Experts and Qualifications: Not applicable, as a test set requiring ground truth establishment by experts is not described in this document.

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

• Adjudication Method: Not applicable, as a test set or study requiring adjudication is not described.

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

• MRMC Study: Not applicable. This device is a nerve integrity monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" in the context of imaging. It's an intraoperative neurophysiological monitor.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" study as might be conducted for AI software. The device is a hardware system with integrated monitoring capabilities. Its performance is inherent to its function, but a "standalone" study in the AI sense is not described. The device's operation is intended for use by a clinician during surgery.

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

• Type of Ground Truth: Not applicable, as a formal study requiring ground truth for performance evaluation is not described. The device's function involves real-time physiological monitoring, where the "truth" is the presence or absence of nerve activity in response to stimulation, directly observed or inferred by the operating surgeon based on the monitor's output.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning algorithm requiring a "training set" in the typical sense for AI development.

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

• Ground Truth for Training Set: Not applicable.

Summary of what is present:

The 510(k) summary indicates that the Medtronic Nerve Integrity Monitor 3.0 is intended for "locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots." It claims substantial equivalence to two predicate devices (Medtronic NIM Spine K031510 and NIM PRS K024316) based on "indications, design, technology, functions, and principle of operation." This suggests that the "acceptance criteria" and "proof" are based on the device's similarity to already cleared devices, rather than a new de novo clinical study with quantified performance metrics against explicit acceptance criteria.

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