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The Diego Elite Drill is intended for cutting, drilling, and removal of bone, and soft and hard tissue in general ENT, and Otoneurologic procedures when used in conjunction with the Diego Elite console.

Specific procedures would include Mastoid Neurotology (Mastoidotomy) and Stapes procedures.

The Diego Elite Drill is similar to the drills associated with the predicate Diego® RF Powered Dissector and Drill System cleared under K034004. The Diego Elite Drill is the next generation drill and it is functionally equivalent to the predicate Gyrus ACMI product and other predicates.

The proposed Drill and accessories are to be used only in conjunction with the Diego Elite system (K123429) for Otologic procedures. The Diego Elite system original submission did not include an Otologic drill, and the predicate (K034004) is not compatible with the Diego Elite system.

Accessories include straight and angled attachments, an irrigation clip, various burrs, an irrigation tubeset, a cleaning kit, and a cleaning / sterilization tray. The drill base plugs into the existing Diego Elite console and is activated by the existing Diego Elite footswitch. The drill base and the straight and angled attachments, and irrigation clip are provided non-sterile and are reusable. The burrs and tubeset are provided sterile and are single-use. The cleaning kit is provided non-sterile and is single-use.

This document describes the premarket notification for the "Diego Elite Drill" (K152744), a surgical drill intended for ENT and Otoneurologic procedures. The submission claims substantial equivalence to existing predicate devices.

Here's an analysis of the acceptance criteria and study data:

Acceptance Criteria and Device Performance

The acceptance criteria for the "Diego Elite Drill" are primarily based on simulated use testing and preclinical evaluations to demonstrate substantial equivalence to predicate devices, focusing on functionality, usability, and safety. There are no explicit quantitative performance metrics like sensitivity, specificity, or AUC provided in the context of diagnostic accuracy, as this is a surgical device. Instead, performance is evaluated through surgeon feedback against predefined usability criteria.

Study Details

1. Sample size used for the test set and the data provenance:

   • Simulated Use Testing (Phacon Temporal Bone Analog):
     • Sample Size: 5 ENT surgeons.
     • Data Provenance: Not specified, but likely within the US, given the FDA submission. The study is prospective, involving surgeons evaluating the device in a controlled simulated environment.
   • Feasibility DVS Study (Cadaver Heads):
     • Sample Size: 10 ENT surgeons.
     • Data Provenance: Not specified, but likely within the US. The study is prospective, involving surgeons evaluating the device on cadaver heads.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For this type of surgical device, the "ground truth" for performance is established by the expert opinion and experience of the participating surgeons (5 ENT surgeons for simulated use, 10 ENT surgeons for DVS study). Their feedback on usability, ergonomics, and performance against the stated indications for use serves as the basis for assessing the device's acceptable performance compared to predicate devices.
   • Qualifications of Experts: All participants were "ENT surgeons." Specific years of experience are not detailed in the provided summary.

3. Adjudication method for the test set:

   • Surgeons provided individual scores/feedback which were then averaged to reach a collective assessment against predetermined acceptance thresholds. There is no mention of a separate adjudication panel or consensus process beyond the collective average.

4. 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 was not done. This is a surgical device, not an AI-assisted diagnostic tool, so this type of study is not applicable. The comparison made is between the new device and predicate devices in terms of general performance and safety, primarily through surgeon feedback.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, a "standalone" algorithm-only performance study was not done. This device is a manual surgical tool that requires human operation; its performance is inherently tied to human interaction.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the device's performance relies on expert opinion and feedback from ENT surgeons during simulated use studies. This is qualitative and subjective data collected through surveys, assessing aspects like usability, ergonomics, and performance in cutting/drilling tissue.
   • For biocompatibility and electrical safety, the "ground truth" is adherence to established international standards (ISO, IEC) and passing results on specific laboratory tests.

7. The sample size for the training set:

   • The document does not describe a "training set" in the context of machine learning or AI. This is a medical device subject to bench testing, biocompatibility, and human factors (usability) assessments. The device's design and development would have involved iterative testing and refinement, but this isn't analogous to an AI training set.

8. How the ground truth for the training set was established:

   • As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance characteristics (e.g., torque, vibration, cutting ability) are established through engineering design specifications and verified through bench testing, guided by an understanding of surgical requirements and risk analysis.

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