(174 days)
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.
§ 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.