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510(k) Data Aggregation
(142 days)
SENTIO MMG Gen 2
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."
| Feature/Attribute | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Consistent with predicate devices; no new questions of safety or effectiveness. | Substantially equivalent; differences do not change intended use or raise new questions of safety or effectiveness, as demonstrated by risk-based verification and validation testing. |
| Capital Equipment (Control Unit & PC/Display) | Enhanced signal acquisition does not raise new safety/effectiveness questions; substantially equivalent for detecting muscle events. Meets same acceptance criteria and consensus standards as predicate for display size and weight. | Enhanced signal acquisition does not raise new questions of safety and effectiveness based on bench testing and comparative performance evaluation. Substantially equivalent to secondary predicates for detecting muscle events. Meets same acceptance criteria and conforms to same consensus standards as primary predicate for display size and weight. |
| System Stimulation (Ranges, Control, Voltage, Waveform, Pulse Width, Rate) | Ranges same as or within predicate/reference devices; same intended function. Same as primary predicate or within ranges/less than for secondary/reference. | Substantially equivalent; ranges are the same as, or within, the ranges of the primary predicate device, secondary predicates, or reference device and have the same intended function. Maximums are within limit settings. Same as primary predicate for waveform and pulse width also substantially equivalent to predicates/reference. Same as primary predicate and same or less than secondary predicates/reference for stimulation rate. |
| Sensors (Signal, Attachment, Size, Connector, Technology, Operating Voltage) | Same signal type, attachment site as primary predicate. Same performance criteria with reduced size. Substantially equivalent connector type and technology with same performance requirements. Meets same performance with lower voltage. | Same as primary predicate for signal and attachment site. Same performance criteria with reduced site attachment for size. Substantially equivalent connector type (3.5mm stereo plug) and technology (Digital) as evidenced by comparative performance evaluation. Substantially equivalent operating voltage (1.8V vs 3.3V) - lower power consumes less energy yet meets same performance. |
| Overall Performance | Performs as well as predicate devices and/or conforms to recognized consensus standards. | Performs as well as the predicate devices and/or conforms to recognized consensus standards for operating conditions, electrical safety, electromagnetic compatibility, hardware and disposable device functionality, signal acquisition equivalence, comparative performance evaluation, biocompatibility, shelf-life, sterilization, packaging integrity, and software validations. |
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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(174 days)
SENTIO MMG Pedicle Access Needles
The SENTIO MMG Pedicle Access Needles are indicated for use in pedicle pilot hole preparation and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The SENTIO MMG Pedicle Access Needles are surgical instruments that incorporate insulated probes with standard connectors to ensure maximum ease of use and compatibility with the Sentio MMG Nerve Mapping and Avoidance System for use during surgeries in which a motor nerve is at risk. The SENTIO MMG Pedicle Access Needles are utilized for pedicle preparation in spine surgery with application of dynamic stimulation for nerve detection. They are provided sterile (ethylene oxide) and have two components: Needle (cannula and trocar) and 2.5m Stimulation Cable. The cannula is marked with equidistant reference depth markers (1cm) relative to the distal [to user] end.
The provided document is a 510(k) Summary for the SENTIO MMG Pedicle Access Needles (K173134). This document pertains to the clearance of a medical device and describes non-clinical performance testing. It does not describe a study involving an AI algorithm or human readers. Therefore, I cannot provide details on AI-specific criteria, sample sizes for test/training sets for AI, expert adjudication of AI results, MRMC studies, or standalone algorithm performance.
However, I can extract the acceptance criteria and performance data for the non-clinical tests that were performed for this device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implied from "Conclusion") | Reported Device Performance |
|---|---|---|
| Durability | The materials and mating interfaces survive the force of entering the pedicle. The interface between handles remains intact. The stylet is sufficiently sharp to pass through bone. The needle cannula beveled edge is sufficient to dig into bone. | "All samples passed the acceptance criteria. The durability of the subject device has been determined substantially equivalent to the predicate." (Testing used simulated bone material.) |
| Wire to Plug Connection | The connection wire component part, when inserted into a test sample to accommodate a resistance fit, must not disconnect when subjected to tensile force up to a certain threshold (implied by "All samples passed the acceptance criteria"). | "All samples passed the acceptance criteria. The subject device connection assembly has been determined substantially equivalent to the predicate." (The sample construct was subject to tensile force until the wire disconnected from the sample handle, implying a successful withstand up to a predefined force or that disconnection occurred above a limit, or that no disconnection occurred.) "The wire to plug connection of the subject device was tested for tensile force resistance. The plug from the connection wire component part was inserted into a test sample intended to accommodate a resistance fit. The sample construct was subject to tensile force until the wire disconnected from the sample handle." |
| System Compatibility | The device must maintain compatibility with the NeuralMAS™ (K100992) predicate and provide electrical isolation such that energy delivery is focused only from the distal tip of the needle. | "Test results demonstrated subject device compatibility with the predicate NeuralMAS™ (K100992) system." |
| Electrical Stimulation | Compatibility with electrical stimulation sources of 100V, 200V, and 300V. | "Compatibility with electrical stimulation sources was verified, supporting substantial equivalence of the subject device." |
| Biocompatibility | Compliant with ISO 10993-1 for an external communicating device for tissue/bone contact of limited duration. Cleaning validations confirm removal of processing reagents. | "The biocompatibility of the subject device has been assessed as substantially equivalent to the predicate." (Patient contacting materials: Stainless Steel with Parylene C coating, unchanged from predicate. Stainless Steel has a history of clinical use and biocompatibility.) |
| Sterility | Sterilization method validated per ISO 11135-1 with a Sterility Assurance Level (SAL) of 10⁻⁶. Sterilization residual levels comply with ISO 10993-7. | "The subject devices will be provided sterile with a SAL of 10⁻⁶. The sterilization residual levels were determined compliant with ISO 10993-7 for limited exposure devices. Delivery state of the subject device is determined to be substantially equivalent to the predicate." |
Regarding the AI-specific questions (which are not applicable to this document):
- Sample size used for the test set and the data provenance: Not applicable, no AI algorithm described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI algorithm described.
- Adjudication method: Not applicable, no AI algorithm described.
- 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: Not applicable, no AI algorithm or human-in-the-loop study described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no standalone AI algorithm described.
- The type of ground truth used: Not applicable, no AI algorithm described. For the physical device, the "ground truth" for performance was based on engineering and material science standards and testing protocols.
- The sample size for the training set: Not applicable, no AI algorithm described.
- How the ground truth for the training set was established: Not applicable, no AI algorithm described.
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(387 days)
SENTIO MMG
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.
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