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The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.

The evonos evoDrill cranial perforator are single-use for trephining the cranial bone. The perforators have an automatic stop mechanism that stops the trephination process as soon as the skull bone has been pierced. The two variants evoDrill cranial perforator 3-flutes and evoDrill cranial perforator 4-flutes are available in two versions that are suitable for different bone thicknesses.

The first version is used from bone thicknesses of 3mm, the second version is used for trepanation with bone thicknesses between 1mm and 3mm. Both variants are available in four different diameters.

The evonos evoDrill cranial perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr holes through the skull of a patient. The evonos evoDrill cranial perforator are devices similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra Cut Automatic Cranial Drill DGR-1 #200-241; DGR-II #200-251 and Codman Disposable Perforators 26-1222, 26-1223). The evonos evoDrill cranial perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 RPM to 1500 RPM.

The provided text describes a 510(k) premarket notification for the "evoDrill Cranial Perforator," a single-use surgical device used for cranium perforation. The document focuses on demonstrating substantial equivalence to predicate devices through various tests, including biocompatibility, sterilization, and cutting performance.

However, the provided document does not contain information related to an AI-based or software-driven medical device study. The device described is a mechanical surgical tool. Therefore, several of the requested information points, such as AI-specific acceptance criteria, multi-reader multi-case studies, ground truth establishment for training sets, etc., are not applicable and cannot be extracted from this document.

The available information pertains to the performance testing of a physical medical device.

Information Extracted from the Provided Document:

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

Based on the "PERFORMANCE TESTING" section:

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

• The document states "All tested specimen confirm..." for sterilization and cutting performance, and "All biocompatibility testing confirmed..." for biocompatibility. However, specific numerical sample sizes are not provided for any of these tests.
• Data Provenance: Not explicitly stated, but given the manufacturer (evonos GmbH & CO. KG) is based in Germany, the testing was likely conducted in Germany or a location compliant with international standards referenced (ISO). The terms "retrospective or prospective" are not applicable to the type of device and testing described.

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

• This concept is not applicable to the acceptance criteria and testing described for this mechanical device. Ground truth, in this context, would refer to objective measurements of device performance (e.g., sterilization levels, mechanical integrity, functional features) rather than expert interpretation of medical images or data.

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

• This concept is not applicable to the acceptance criteria and testing described for this mechanical device. Adjudication methods are typically used in studies involving subjective interpretation, often by multiple readers, which is not the case here.

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. This device is a mechanical cranial perforator, not an AI-based diagnostic or assistive software. No human reader study, AI assistance, or MRMC study was performed or mentioned.

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

• Not applicable. This is a mechanical device, not an algorithm or software. Its performance is inherent to its physical properties and design.

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

• For this mechanical device, the "ground truth" for the performance tests would be based on objective measurements and adherence to engineering and medical device standards (e.g., ISO standards).
  • For biocompatibility: Lab results adhering to ISO 10993.
  • For sterilization: Lab results showing a validated Sterility Assurance Level ($10^{-6}$) per ISO 11137.
  • For cutting performance: Mechanical measurements of auto-stop functionality, drilling time, and resulting burr hole characteristics against defined specifications and implied comparison to predicate device performance. It doesn't involve medical "outcomes data" in the sense of patient follow-up or disease progression, but rather the immediate success of the mechanical function.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not applicable. As above, it's a mechanical device, not an AI model.

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