(196 days)
The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine.
The SeaSpine Monopolar Probes conduct electrical stimulation to nervous tissue that may be present in close proximity of the surgical corridor to the spine. This system is not comprised of a nerve stimulator or recorder; instead it will use conventional stimulators found in the market. The SeaSpine Monopolar Probes are insulated by a biocompatible PEEK (polyetheretherketone) layer all around one or more conductive stainless steel wire(s) with the exception of the distal and proximal ends. The distal end contacts the target tissue and the proximal end connects to standard intraoperative neuromonitoring monopolar stimulator) that offers triggered electromyography (EMG) capability. Triggered EMG is a standard intraoperative practice where motor nerves are stimulated and their corresponding muscle group response is recorded, allowing for avoidance of nervous tissue during surgical approach. The proximal connector design meets the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.
The provided text describes a 510(k) submission for the SeaSpine Monopolar Probe System, which is a medical device for nerve stimulation and tissue dilation during spinal surgery. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way one might find for a novel diagnostic or therapeutic algorithm.
Therefore, the study design and acceptance criteria metrics requested in the prompt do not directly apply to this type of regulatory submission. The "acceptance criteria" here are effectively satisfied by demonstrating that the device is "as safe, as effective, and performs as well as or better than" the legally marketed predicate devices through engineering analysis, materials comparison, and adherence to relevant standards.
However, I will extract the available information to address the prompt's points as closely as possible within the context of this 510(k) submission.
Summary of Acceptance Criteria and Device Performance (based on Substantial Equivalence)
The "acceptance criteria" in this context are met by demonstrating substantial equivalence to the predicate devices. The "reported device performance" is essentially that it functions similarly to the predicates.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (vs. Predicates) |
|---|---|
| Indications for Use: Similar or identical | The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine. This is deemed substantially equivalent to predicates that perform tissue dissection and stimulation of motor nerves for location and identification during surgery, including spinal nerve roots. |
| Materials: Similar or identical | Manufactured from similar or identical materials as predicate devices (Stainless Steel, PEEK). The biocompatibility was assessed per ISO 10993 and USP Class VI. Materials have a long track record of use in the medical device industry. |
| Design: Similar or identical | Electrical conduit insulated with exception to distal tip and proximal connector (same as predicates). Electrical conduction material (Stainless Steel - same as Medtronic, similar to Nuvasive which also uses Aluminum). Electrical patient contact surface (Stainless Steel - same as Medtronic, similar to Nuvasive). Proximal Stimulator Connector (Yes - same as predicates). Biocompatible plastic electrical insulation (Yes - same as predicates). Steam Sterilizable Reusable (Yes - same as Medtronic, similar to Nuvasive). |
| Functionality: Similar or identical | Functions similarly; employs conventional stimulators for triggered electromyography (EMG) capability to allow avoidance of nervous tissue during surgical approach. Considered substantially equivalent. |
| Safety and Effectiveness: No new issues raised | Demonstrated through engineering analysis, specifications, labeling, and comparison to predicates. Conforms to IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12 for electrical safety. |
Given that this is a 510(k) submission based on substantial equivalence, the following points address what is available in the document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document does not describe a clinical "test set" in the traditional sense of a clinical trial for performance evaluation of an AI/ML device. The evaluation is primarily based on engineering analysis, material comparisons, and adherence to existing standards, comparing the new device to established predicate devices already on the market. Therefore, there's no sample size or specific data provenance mentioned for a test set.
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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)
- Not applicable. The ground truth, in this context, is the established safety and effectiveness of the predicate devices and the relevant industry standards (ISO 10993, USP Class VI, IEC 60601-1). There is no mention of experts establishing ground truth for a novel "test set" for this device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication process is described in this 510(k) submission.
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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. This device is not an AI/ML diagnostic or assistive technology and no MRMC study was conducted or is relevant to this type of device submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical instrument (monopolar probe) and not an algorithm or software-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (Medtronic Xomed Stimulus Dissection Instruments (K014165) and Nuvasive Neurovision JJB System (K051718)), along with adherence to recognized performance and safety standards (ISO 10993 for biocompatibility, USP Class VI for adhesive, and IEC 60601-1 for electrical safety).
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The sample size for the training set
- Not applicable. This device is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML device requiring a training set.
§ 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.