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The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.

The UNIDRIVE S III ENT is a motorized surgical device system used for the excision, ablation, removal or transection of bones/tissues during head, neck, ENT, or otoneurological surgical procedures. The system components include a control unit used in conjunction with the High-Speed Micro Motor that houses the high-speed handpieces and DrillCut-X® II Shaver handpieces. The modifications made to the UNIDRIVE® S III ENT system is the addition of the DrillCut-X® II-35 and DrillCut-X® II-35 N Shaver handpieces. Additional accessories used with the UNIDRIVE S III ENT system include the shaver blades, sinus burrs and the sinus burr 35k.

The provided text describes a 510(k) premarket notification for the UNIDRIVE S III ENT system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study for a new AI/CAD device. Therefore, many of the requested criteria related to AI/CAD system performance, such as human reader improvement with AI assistance, sample sizes for AI training/test sets, expert qualifications for ground truth, and adjudication methods, are not applicable or findable in this document.

However, I can extract the information relevant to the device's technical performance and the non-clinical testing performed to demonstrate its acceptance criteria.

1. A table of acceptance criteria and the reported device performance

The document doesn't present acceptance criteria in a quantitative table with specific performance metrics for the device itself (like accuracy, sensitivity, specificity for an AI system). Instead, its acceptance appears to be based on adherence to recognized consensus standards and successful completion of specific non-clinical tests to demonstrate safety and effectiveness, and substantial equivalence to a predicate device.

Here's a summary of the non-clinical performance data provided, which serves as the "acceptance criteria" through compliance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is a surgical drill system, not an AI/CAD system evaluated on patient data. The "test set" here refers to the device itself undergoing various engineering and biological safety tests. No patient data or associated provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in the context of AI/CAD systems usually refers to verified diagnoses or findings from medical images. For this surgical device, "ground truth" would be established by engineering standards, material science, and biological safety standards, which are inherent to the testing methodologies used. The document does not specify the number or qualifications of experts involved in the direct testing of the device, beyond implying qualified personnel conducting the tests and regulatory bodies reviewing the submissions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations for establishing ground truth in AI/CAD image analysis studies. This document discusses mechanical, electrical, and biological testing of a surgical device.

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

Not applicable. An MRMC study is relevant for AI/CAD systems that assist human interpretation of medical images. This document describes a surgical drill system.

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

Not applicable. This device is a surgical hardware system, not an AI algorithm. Its performance is inherent to its mechanical and electrical function.

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

The "ground truth" for this device's acceptance is established by engineering standards, material science, and biological safety standards, as demonstrated through the various non-clinical tests (electrical safety, EMC, cleaning/sterilization validity, rotation speed/torque inspection, biological evaluation) and compliance with national and international standards (IEC, ISO, ANSI/AAMI).

8. The sample size for the training set

Not applicable. This document describes a hardware device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As noted above, this is not an AI/CAD algorithm.

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