(90 days)
The Baxano, Inc. Neural Localization Probe is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
The Neural Localization Probe is based on the Baxano Standard Probe (for use with the Ultra Low Profile Rongeur and the Baxano Microblade Shaver) with the modification of circumferential bipolar electrodes. The Neural Localization Probe provides the surgeon additional feedback for localizing the nerve root instead of removing additional bone to improve visualization within the spinal column. A Switch Box directs the stimulus signal so that the nerve can be located on the top, bottom, left or right of the Neural Localization Probe.
The Neural Localization Probe is made of stainless steel shaped to enable the surgeon to utilize both direct visualization and tactile feedback in order to evaluate foraminal bone and soft tissue landmarks during placement of Baxano cutting devices. The Switch Box allows energy to be directed from a commercial EMG system to one of four pair of bipolar electrodes so that the surgeon gets feedback as to the relative location of the nerve root to the probe placement.
The provided text describes the Baxano Neural Localization Probe, but it does not contain specific numerical acceptance criteria for its performance or a detailed study report that would typically be associated with AI/ML device evaluations. This document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical trial report with predetermined acceptance criteria for AI performance.
Therefore, I cannot populate all the requested information as it is not present in the given text.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical targets; instead, the implied criterion is accurate and reproducible real-time feedback about nerve function, especially when visualization is impaired. | "The nerve root could be identified 100% of the time relative to the Probe positioning." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number. The text mentions "animal studies including blinded studies."
- Data Provenance: Animal studies. No country of origin is specified. The studies were retrospective or prospective is not mentioned, though "blinded studies" suggests a structured, prospective approach.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The statement implies the ground truth was established by direct observation or histological examination in the animal model, but it doesn't detail the involvement of human experts in establishing truth for a test set as would be typical for an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This refers to consensus methods for human readers, which is not described for this device evaluation.
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:
- Not applicable. This device is not an AI-assisted diagnostic tool for human readers but a surgical instrument that provides direct feedback.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a way. The device itself (the probe) is the "standalone" component in the animal studies, where it demonstrated its ability to identify nerve roots without reference to human interpretation of images or data. The "100% identification" was attributed to the probe's function.
7. The type of ground truth used:
- Direct observation/identification of nerve root position in animal models, likely confirmed by anatomical dissection or other physiological markers in the animal studies.
8. The sample size for the training set:
- Not applicable/Not specified. This device is not described as an AI/ML system that undergoes a "training set" phase in the typical sense. It's a hardware device evaluated through mechanical tests and animal studies.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 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.