Search Results

To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in various monopolar and bipolar configurations according to the required application. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof" safety connector(s) on the distal end. Monopolar electrodes require a separate stimulator return electrode. Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve. The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope.

This submission pertains to Axon Systems' Disposable Stimulator Probes, which are devices used to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results. As such, the requested information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) is not present in the provided text.

The 510(k) summary only states the following:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The summary focuses on technological characteristics and substantial equivalence, not specific performance metrics against pre-defined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information on test set sample sizes or data provenance is available.

3. 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): This information is not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned, as there is no test set or ground truth establishment process described.

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: This is not applicable. The device described is a medical instrument (stimulator probe), not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as there isn't a diagnostic algorithm undergoing validation against a ground truth.

8. The sample size for the training set: Not applicable and not mentioned.

9. How the ground truth for the training set was established: Not applicable and not mentioned.

Summary of the 510(k) Conclusion:

The document concludes that "Axon Systems' Disposable Stimulator Probes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident." This equivalence is based on the description of technological characteristics, such as:

• Identical materials: "Materials used are the same as in the predicate devices."
• Similar design: Insulated probe shaft of various lengths mounted to a plastic handle, electrically connected to a "touch-proof" safety connector.
• Intended Use: "To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery," which is presumably consistent with the predicate devices.

The predicate devices mentioned are:

• Technomed Europe - Disposable Probes (K050325)
• Xomed Surgical Products - Ball Tip Monopolar stimulating probe (K992869)

In essence, the "study" proving the device meets acceptance criteria in a 510(k) submission like this is primarily a demonstration of substantial equivalence to already cleared devices, rather than a de novo clinical trial with defined acceptance criteria and performance outcomes.

Ask a specific question about this device