Search Results

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.

Ask a specific question about this device