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When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.

The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.

The Stimulating Bur Guard is a sterile, single use device used in conjunction with the XPS 3000 BF Powered Drill System and the Medtronic Xomed Nerve Monitoring System. It locks onto a handpiece and has an opening on the anterior end to accept a standard bur / blade. The primary purpose of the Stimulating Bur Guard is to deliver the stimulating current from the Nerve Monitoring console to the standard bur / blade on the drill handpiece. The second purpose of the Stimulating Bur Guard is to provide support for the extended length burs.

Here is an analysis of the provided 510(k) summary regarding the Stimulating Bur Guard, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set in the context of clinical or performance data from human subjects. The studies described are primarily bench testing and biocompatibility testing.

• Bench Testing: No sample size is explicitly stated for the number of devices or tests performed in areas like reliability, current delivery, or noise.
• Biocompatibility: No sample size of materials or tests is explicitly stated, beyond "all patient contacting materials."
• Data Provenance: The studies are described as bench testing and laboratory studies (biocompatibility, shelf life). There's no mention of human subject data, retrospective or prospective, or country of origin for such data.

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

This information is not applicable and not provided in the document. The device is a surgical accessory, and the studies described are technical performance evaluations, not clinical studies requiring expert ground truth for interpretation of outcomes or images.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies, especially those involving expert interpretation of data (e.g., imaging studies), which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. Such studies are generally conducted for diagnostic devices (e.g., AI for medical imaging) to assess the impact of AI on human reader performance, which doesn't apply to this surgical stimulating bur guard.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies described are essentially standalone performance evaluations of the device's physical and electrical properties. There is no "algorithm" in the sense of AI or software interpreting data for human users. The device itself is an accessory to existing systems (Nerve Integrity Monitor and XPS Drill Systems). The various bench tests directly assess the device's intended function and safety characteristics in a standalone manner (though in conjunction with the specified predicate systems for electrical tests).

7. The Type of Ground Truth Used

The "ground truth" for the various tests described would be based on:

• Bench Test Specifications: Pre-defined engineering specifications, electrical standards, and performance limits for parameters like current delivery, noise, temperature, and reliability.
• Regulatory Standards: Compliance with ISO and FDA biocompatibility standards.
• Manufacturer's Internal Standards: For shelf life and operating life tests, likely based on internal validation protocols.

Essentially, the ground truth is derived from objective engineering and regulatory standards, rather than clinical outcomes, pathology, or expert consensus on clinical data.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device does not use an "algorithm" or "AI" that requires a training set. The descriptions relate to traditional device verification and validation.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided as there is no training set for this device.

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