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This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.

SENTIO MMG Gen 2 is a multichannel device for locating, mapping and assessing the status of motor nerves during surgical procedures. SENTIO MMG Gen 2 alerts the user of recorded mechanical activity (termed mechanomyography, or MMG) from muscles innervated by affected nerves, which may originate from operator applied electrical stimulus or unintentional innervation of the nerve as a result of nerve impact, retraction, compression, or other mechanical factors. The device will assist with nerve identification and assessment by alerting the surgeon when monitored nerves are activated. The device will also assist with tracking the status of monitored nerves throughout the course of surgical intervention. The Sentio MMG Gen 2 system consists of capital equipment and disposable devices, both sterile and non-sterile.

The provided text describes the SENTIO MMG Gen 2, a surgical nerve stimulator/locator that uses mechanomyographic (MMG) signals and electrical stimuli to assist in locating and mapping motor nerves during surgery. The submission to the FDA focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of specific acceptance criteria. Instead, it generally states that the device's technological characteristics, performance, and intended use are consistent with the predicate device. It also mentions that the device "meets the same acceptance criteria and conforms to the same consensus standards as the primary predicate device" for certain attributes.

For "enhanced MMG signal acquisition," it notes that this "does not raise new questions of safety and effectiveness based on results of bench testing and comparative performance evaluation." Furthermore, for the "Number of Channels," it states "Enhanced signal acquisition in comparison to primary predicate - Substantially equivalent to secondary predicates for same purpose of detecting a muscle event as evidenced by comparative performance evaluation."

Therefore, based on the provided text, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to the predicate devices and conformity to recognized consensus standards, with performance being "as well as the predicate devices."

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

The document states "comparative performance evaluation using clinically relevant MMG signal simulation to capture a statistically significant sample to demonstrate high agreement with respect to performance of the primary predicate."

• Sample Size for Test Set: "statistically significant sample" - Specific numerical sample size is not provided.
• Data Provenance: "clinically relevant MMG signal simulation" - This indicates the use of simulated data, not directly patient-derived data from a specific country. This is a retrospective approach as it evaluates the device against pre-defined simulations rather than collecting new patient data.

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

The document does not mention the use of human experts to establish ground truth for the test set. The validation seems to rely on "clinically relevant MMG signal simulation" and comparison to predicate device performance.

4. Adjudication method for the test set

Not applicable, as no human experts are mentioned for establishing ground truth or adjudication in the test set.

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 MRMC comparative effectiveness study involving human readers or AI assistance is mentioned in the provided text. The device is a "Surgical Nerve Stimulator/Locator" that provides information directly to the surgeon, but the study described is a non-clinical performance evaluation, not a human readability study.

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

Yes, the described "comparative performance evaluation using clinically relevant MMG signal simulation" focused on the device's ability to "detect a muscle event" and its "signal acquisition equivalence." This constitutes a standalone performance evaluation of the device's technical characteristics without human operators in a clinical setting; the output of the device is then interpreted by the surgeon.

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

The ground truth for the device's performance assessment appears to be based on pre-defined "clinically relevant MMG signal simulation" models which are designed to represent actual physiological signals. This is implicitly referenced in the statement "comparative performance evaluation using clinically relevant MMG signal simulation to capture a statistically significant sample to demonstrate high agreement with respect to performance of the primary predicate." The primary predicate's performance presumably serves as a benchmark for this simulated ground truth.

8. The sample size for the training set

The document does not mention a "training set" or machine learning being used in the development or evaluation of the device. The evaluation is described in terms of "non-clinical testing" and comparison to a predicate device.

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

Not applicable, as no training set or machine learning is mentioned.

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This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.

The NeuralMAS™ system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The NeuralMAS™ system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery. The monitor will assist early nerve identification by providing the surgeon with a tool to help locate and identify the particular nerve at risk to minimize trauma by alerting the surgeon when a particular nerve has been activated.

The NeuralMAS™ system consists of a reusable Patient Module, a Control Unit comprised of a touch-screen PC and an assortment of disposable conductive probes, stimulators, sensors, electrodes and electrode leads.

Here's a breakdown of the acceptance criteria and the study details for the NeuralMAS™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity or specificity targets). Instead, the study's acceptance was based on demonstrating "statistical agreement" and "correlation" with a predicate device.

1. The NeuralMAS™ system's principle functions are effective for ascertaining and monitoring spinal nerve status and location.
2. Data acquired by NeuralMAS™ during simulated surgical use in an animal model correlate well with data acquired simultaneously by a predicate device. |
   | Effectiveness of principle functions | Demonstrated effectiveness in ascertaining and monitoring spinal nerve status and location. |
   | Correlation of acquired data with predicate device | Good correlation between data acquired by NeuralMAS™ and data acquired simultaneously by a predicate device in an animal model. |
   | Safety and effectiveness comparable to predicate device | Concluded to be "as safe, as effective and performs as well as the legally marketed predicate device." |
   | Substantial equivalence in function to predicate device | Concluded to be "substantially equivalent in function to the legally marketed predicate device." |

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

• Sample Size: Not explicitly stated. The study mentions a "comparative performance evaluation was conducted in the sheep," implying a limited animal study, but the specific number of sheep or cases is not provided.
• Data Provenance: Prospective animal study conducted in "sheep" (animal model). The country of origin is not specified, but the submission is to the US FDA, so it's likely a US-based study or one adhering to US regulatory standards.

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

Not applicable. The study was a comparative performance evaluation between the subject device and a predicate device in an animal model, not an assessment against human-established ground truth. The "ground truth" was essentially the synchronous readings from the predicate device and the physiological responses observed during the animal experiment.

4. Adjudication Method for the Test Set

Not applicable. There was no mention of human expert adjudication for the animal study. The comparison was statistical agreement and correlation between the two devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The study described is a non-clinical animal study comparing the device to a predicate, not an MRMC study involving human readers.

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

Yes, in essence. The "comparative performance evaluation" in the sheep assessed the device's ability to ascertain and monitor nerve status and location, and its data acquisition, in direct comparison to the predicate device. This is a standalone assessment of the device's functional performance in a simulated surgical environment. Human interpretation or intervention as part of the performance measurement itself (beyond setting up and operating the devices) is not indicated.

7. The Type of Ground Truth Used

The "ground truth" for the test set was the data simultaneously acquired by the predicate device and the directly observable physiological responses in the animal model. The study aimed to show correlation and agreement between the NeuralMAS™ and the predicate device's readings. It did not rely on a separate, independent "gold standard" or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a medical device that records mechanomyographic signals and uses electrical stimulation. The device itself is not described as involving a machine learning algorithm that requires a "training set" in the traditional sense. The "training" for the device would have involved engineering development and calibration, not a data-driven machine learning training set as would be found in AI/ML device submissions.

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

Not applicable, as there's no mention of a traditional machine learning training set for this device.

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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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