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The DragonFly™ Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

The DragonFly™ Surgical Drill System consists of a small surgical power tool (handpiece); a battery powered footswitch for control of speed and direction; various cutting instruments (burs); angled adaptors to adjust the angle between the handpiece and the bur; and a sterilization tray. Accessories include a battery charger and a battery replacement kit.

This document describes the DragonFly Surgical Drill System, a surgical power tool for light drilling of bones in procedures like stapedotomy or ossiculoplasty.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets for each performance metric, as might be seen for AI/Software-as-a-Medical-Device (SaMD) assessments. Instead, it describes performance verification and validation studies by comparing the device against predicate devices and demonstrating compliance with relevant standards. The "acceptance criteria" are implied by successful completion of these tests and comparable or superior performance to predicates.

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

• Functionality after repeated autoclave cycles: 13 handpieces.
• Biocompatibility: Representative burs were tested.
• Bench Testing and Surgical Evaluation of Performance:
  • Comparison of handling and bur runout: Not explicitly stated beyond "The DragonFly Surgical Drill system was tested in parallel with the predicate device".
  • Temporal bone labs evaluation: 15 Otologic surgeons.
  • Comparison by board-certified otolaryngologist: One board-certified otolaryngologist.
• Data Provenance: Not explicitly stated as retrospective or prospective or country of origin in the provided text. However, temporal bone labs and surgeon evaluations suggest a prospective, controlled testing environment, likely in the US where the submitter is located.

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

• Autoclave/Drill Speed/Simulated Use/Usability: While the tests involve "users" and "surgeons," the "ground truth" here is objective performance metrics (RPM, presence of issues) and user feedback on usability, rather than diagnostic "ground truth" like in imaging studies.
• Surgical Evaluation:
  • 15 Otologic surgeons: These surgeons were "familiar with and had used the predicate Xomed Skeeter drill." This implies clinical expertise in oto-laryngology. Their specific years of experience are not stated.
  • 1 board certified otolaryngologist: Performed surgical procedures on human temporal bone and provided comparative scores for 20 performance characteristics. This qualification establishes significant clinical expertise.

4. Adjudication Method for the Test Set

• For the surgical evaluations:
  • The 15 otologic surgeons provided individual feedback and generally "deemed" the DragonFly as "at least as good as" the predicate. This suggests consensus-based or individual assessments rather than a formal pre-defined adjudication method (like 2+1 or 3+1).
  • The single board-certified otolaryngologist provided comparative scores for 20 characteristics. This was a direct comparison by a single expert.
• For other performance tests (autoclave cycles, biocompatibility, electrical safety, etc.), the adjudication involves meeting predefined engineering specifications and regulatory standards, evaluated through testing rather than expert medical adjudication.

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

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed. This device is a surgical drill system, a hardware device, not an AI/SaMD diagnostic tool. The "readers" here are surgeons evaluating the physical device's performance, not interpreting medical images or data with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• No, this question is not applicable. The device is a surgical drill system; it is not an algorithm or AI. It requires a human operator (surgeon).

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) doesn't directly apply in the same way to a surgical tool. Instead, the "truth" is established through:

• Objective Performance Metrics: RPM, autoclave cycle durability, force measurements (for magnetic latching/drive), biocompatibility test results, electrical safety certifications, shelf-life validation.
• Expert Clinical Opinion/Comparative Assessment: Direct subjective evaluation and comparison by qualified otologic surgeons and a board-certified otolaryngologist during bench testing and temporal bone labs, confirming the device's suitability and comparable performance to established predicates.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device; there is no "training set" in the context of machine learning or AI.

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

• Not applicable. This is a hardware device; there is no "training set" with associated "ground truth."

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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

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