(28 days)
The Baxano, Inc. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
A switch directs the stimulus signal so that the nerve can be located relative to the Neuro Check Device. The Neuro Check Device assists in the localization of nerve roots during spinal column surgery where visualization is limited as an alternative to removing additional bone for direct visualization.
The provided document is a 510(k) summary for the Baxano Neuro Check Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical study with acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) submission.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment methods, and multi-reader multi-case studies are not available in this document.
Here's a breakdown of what can be extracted and what is explicitly not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, accuracy, etc. for the device. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets design specifications | Mechanical and electrical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use. |
| Conforms to design specifications | Baxano has determined, based on the performance testing and animal studies that the Neuro Check Device conforms to the design specifications and is substantially equivalent to the predicate device. |
| Substantially equivalent to predicate | The modified Neuro Check Device is equivalent to the predicate Neural Localization Probe. The Neuro Check Device has the same indications for use and fundamental scientific technology as its predicate. |
| Does not raise new questions of safety or effectiveness | Based upon the indications for use, technological characteristics and performance test results, changes to the Neuro Check Device do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention human patient test sets, sample sizes, or data provenance (country of origin, retrospective/prospective). The performance evaluation was based on "mechanical and electrical performance tests" and "animal studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no human-read test set is described. Performance was evaluated through engineering tests and animal studies.
4. Adjudication Method
Not applicable, as no human-read test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done or reported in this 510(k) submission. There is no mention of human readers improving with or without AI assistance, as this is a medical device for nerve localization, not an AI-assisted diagnostic imaging tool.
6. Standalone Performance Study
The document states that "Mechanical and electrical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use." This indicates some form of standalone testing was performed to ensure the device itself functions as intended. The "animal studies" also demonstrate standalone device performance in a biological setting. However, specific metrics (e.g., probability of correctly locating a nerve) are not provided.
7. Type of Ground Truth Used
For the "mechanical and electrical performance tests," the ground truth would be the expected output or behavior according to engineering specifications and design. For the "animal studies," the ground truth would be the actual anatomical location of nerves as confirmed through direct observation or other validated methods in the animal models.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm that requires a training set in the typical sense. Its function is based on principles of electrical stimulation and feedback.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
Summary of Device and Study Focus:
The Baxano Neuro Check Device is a surgical nerve stimulator/locator. The 510(k) submission (K092729) is for a modification of an existing predicate device (Baxano Neural Localization Probe, K081742) to include monopolar stimulation. The study presented here is a demonstration of substantial equivalence to the predicate device, emphasizing that the fundamental scientific technology remains unchanged, the indications for use are the same, and the modifications do not raise new questions of safety or effectiveness. The performance data relied upon are "mechanical and electrical performance tests" and "animal studies." This type of submission does not typically involve extensive clinical trials with human subjects and corresponding statistical analyses of performance metrics and ground truth as would be seen in a PMA.
§ 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.