(270 days)
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 handpiece. 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, consisting of an active control unit used in combination with: the High-Speed Micro Motor and attaching handpiece and the DrillCut-X® II Shaver handpiece (with optional attaching handle). The surgical device system provides 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 provided document is a 510(k) premarket notification for a surgical device (UNIDRIVE S III ENT). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data like an AI/algorithm-based device.
Therefore, much of the requested information (Acceptance Criteria, Device Performance, Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC study, Standalone performance, Ground Truth types, Training set size, Training ground truth) is not applicable or not available in this document.
However, I can extract what is provided regarding performance characteristics and testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to design specifications | "Study results demonstrate adherence to design specifications." |
| Consistent experimental results | "Experiments yielded consistent results." |
| Consistent test conditions | "Consistent test conditions were maintained throughout the study." |
| Sterility Assurance Level (SAL) of $10^{-6}$ for reusable instruments | "Sterility efficacy demonstrated a sterility assurance level of $10^{-6}$ in a pre-vacuum steam sterilizer." |
| Sufficient recovery efficiency for residual protein after manual cleaning | "Manual cleaning effectiveness was demonstrated with sufficient recovery efficiency for residual protein." |
| Sufficient recovery efficiency for residual hemoglobin after manual cleaning | "Manual cleaning effectiveness was demonstrated with sufficient recovery efficiency for ... residual hemoglobin." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of distinct "test cases" or data points. The performance evaluation is described as "system verification and validation testing" and "performance testing" on the device itself and its components.
- Data Provenance: Not applicable in the context of clinical data. This is a bench testing and cleaning/sterilization validation study performed on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a technical performance study on the device's functionality, cleaning, and sterilization, not a diagnostic or AI performance study requiring expert ground truth setting from medical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a technical performance study, not a study involving human interpretation or consensus.
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 MRMC study was done. This device is an ENT surgical drill system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical device, not an algorithm. Bench tests were performed on the device's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth (for technical performance): Design specifications, validated laboratory methods for sterility testing (e.g., spore-based methods for SAL), and analytical chemistry standards for measuring residual protein and hemoglobin.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.