(387 days)
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 Sentio MMG® system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The Sentio MMG® system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct 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 Sentio MMG® system consists of a reusable Control Unit comprised of a touch-screen PC and Patient Module, a reusable Sensor Connector Module 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 Sentio MMG® Neurosurgical Nerve Locator, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that a "comparative performance evaluation was conducted to assess statistical agreement between the subject device and the predicate." It then concludes that "Results for positive, and overall percent agreement have established that 1) the principle functions of the Sentio MMG® system are effective, such that spinal nerve status and location may be ascertained and monitored, and 2) the data processed by the subject device following surgical use correlate well with those acquired by the predicate device."
However, specific numerical acceptance criteria (e.g., minimum percentage agreement, sensitivity, specificity, or specific statistical thresholds) are not explicitly provided in the document for the new device. The acceptance is based on demonstrating "substantial equivalence" to the predicate device (K100992 NeuralMAS™). This implies that the performance of Sentio MMG® must be comparable to or better than the predicate's established performance without raising new safety or effectiveness concerns.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Principal Functions Effectiveness | Spinal nerve status and location can be ascertained and monitored effectively. | Established as effective. |
| Data Correlation | Data processed by the subject device following surgical use correlate well with those acquired by the predicate device. | Correlate well with predicate device data for positive and overall percent agreement. |
| Safety and Effectiveness | Equivalent to or better than the predicate device, with no new issues raised. | Demonstrated to be as safe, as effective, and performs better than the legally marketed predicate device. |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the comparative performance evaluation or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "market data evaluation" and "non-clinical testing." This often implies internal testing or possibly data collected from the predicate device's use in the market.
3. Number of Experts and Their Qualifications
The document does not mention the involvement of experts for establishing ground truth or evaluating the test results. The assessment relied on statistical agreement between the subject device and the predicate device.
4. Adjudication Method
No adjudication method is mentioned in the document. The comparative evaluation appears to be a direct comparison of the subject device's output against the predicate device's output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is a device that directly measures physiological signals rather than an imaging device requiring human interpretation of images. The device assists in locating and mapping motor nerves, and its performance is evaluated based on its signal output compared to a predicate device.
6. Standalone (Algorithm Only) Performance
A standalone performance evaluation was conducted in the sense that the device's output was statistically compared to the predicate device's output. This is not an "algorithm only" in the context of AI, but rather the device's functional performance in isolation of human decision-making based on the output. The conclusion states: "The conclusions drawn from our non-clinical testing (to include our market data evaluation) of the subject device demonstrates that the subject device is as safe, as effective and performs better than the legally marketed predicate device."
7. Type of Ground Truth Used
The "ground truth" for the comparative study appears to be the performance and data acquired by the predicate device (ISS NeuralMAS #K100992). The study assessed the "statistical agreement" between the subject device's output and the predicate device's output. This is a comparison to a previously cleared device's performance, not an independent clinical ground truth like pathology or expert consensus on nerve presence.
8. Sample Size for the Training Set
The document does not mention a "training set" as this device is not described as an AI/machine learning product in the traditional sense that requires complex algorithm training. The comparison is against an existing predicate device's functionality.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the AI/ML sense) is mentioned or implied for this non-clinical testing. The "ground truth" for the comparison was the predicate device's established performance.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.