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The Baxano Neuro Check™ Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.

The Neuro Check Device is designed to be pulled into the neural foramen by the iO-Flex Wire to enable the surgeon to direct a stimulus signal from a commercial EMG system to electrodes on the device enabling nerve root location prior to using a Baxano cutting and biting device. The Neuro Check Device is manufactured from biocompatible Pebax® tubing and stainless steel with a handle molded from ABS. The proximal end of the device handle has a pair of wires that connect to commercially available EMG systems.

The iO-Flex Wire is manufactured from nickel-titanium wire and connects to the distal end of the Neuro Check Device for placement in the neural foramen. No changes were made to the previously cleared iO-Flex Wire design (K100958) other than packaging modifications to include it within the Neuro Check Device packaging for surgeon convenience.

Since the previous clearance of the Neuro Check Device (K092729; October 2, 2009) changes were made to the physician labeling (the Instructions For Use) intended to provide compatibility with enhanced output stimulus signals of commercially-available intra-operative electromyography (EMG) neuromonitoring systems for motor nerve localization. Specifically, the maximum allowable EMG stimulation current amplitude to the Neuro Check Device was increased from 30 milliamps to 50 milliamps and the maximum current pulse width from 300 microseconds to 500 microseconds to support the stimulation parameters of commercially available EMG systems. There were no design modifications of the Neuro Check Device necessary to conform to the new electrical stimulation specifications.

In addition, several design modifications were implemented since the last Neuro Check Device clearance. These modifications include integrating the separate Switch Box into the Neuro Check Device handle, eliminating the need for this external accessory. The handle itself is now molded from ABS plastic instead of being machined from the same material. Two radiopaque platinum-iridium marker bands were added to the distal flexible section to assist with fluoroscopic positioning of the device. A slight bend is made in the distal flexible segment to assist in orienting the Neuro Check Device as it is positioned with respect to the patient. Lastly, the iO-Flex Wire was added to the Neuro Check Device package for user convenience.

This 510(k) summary describes a device modification, so the study primarily focuses on demonstrating that the modified device remains as safe and effective as its predicate, rather than establishing efficacy for a new device. Therefore, acceptance criteria generally relate to ensuring the device meets relevant safety and performance standards after modification.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified table with corresponding performance. Instead, it describes general non-clinical tests conducted to confirm the modified device meets design specifications and performance characteristics based on its intended use and complies with relevant electrical and safety standards. The performance is indirectly "reported" as compliance with these standards and equivalency to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document states "Mechanical performance tests were conducted" and "The modified Neuro Check Device was subjected to electrical safety and compatibility testing," implying that specific units of the device were tested. However, the exact number of devices or test repetitions is not provided in this summary.
• Data Provenance: The tests are described as "non-clinical tests" conducted on the modified device itself. This indicates laboratory testing, not human or observational data. The provenance is internal to the manufacturer or an approved contract facility for sterilization validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

• Number of Experts: Not applicable/not specified. The "ground truth" for non-clinical performance and safety standards is the standard itself (e.g., IEC 60601-1). The validation of sterilization was done by an "approved contract facility." There's no mention of human expert adjudication for the non-clinical tests described.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. For non-clinical tests like mechanical, electrical, and sterilization, the "adjudication" is typically against pre-defined engineering specifications and regulatory standards. There is no multi-reader or human consensus method involved for these types of tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done?: No, an MRMC comparative effectiveness study was not done or described. This submission is for a device modification (510(k)), which typically focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicates, rather than extensive clinical efficacy studies comparing human reader performance with and without AI assistance. The device is a "Nerve locator" which assists a surgeon, but this filing does not involve any AI component or human interpretation of images requiring an MRMC study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

• Was it done?: Not applicable/not described. This device is not an algorithm, but a physical medical device. Its "performance" is primarily assessed through its physical, electrical, and sterilization characteristics in non-clinical settings, not through an algorithm's standalone performance. The device is intended to be used with a commercial EMG system and a surgeon ("human-in-the-loop"), so "standalone algorithm performance" (without human interaction) does not apply.

7. Type of Ground Truth Used:

• Ground Truth: For the non-clinical tests, the "ground truth" is adherence to established industry and regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ISO 11137-1:2006, ISO 11137-2:2006) and the device's own design specifications.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This document does not describe the development or testing of an AI algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• How Established: Not applicable, as there is no AI algorithm or training set discussed.

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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:

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.

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