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The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool.

The Amorphous Diamond Coated Drill is designed for use in the preparation of an osteotomy for an endosseous dental implant site. The Amorphous Diamond Coated Drill is constructed of surgical grade stainless steel. The bone cutting portion of the drill is coated with amorphous diamond coating.

The provided text describes a 510(k) submission for an "Amorphous Diamond Coated Drill" and its comparison to a predicate device. It specifically states "Biological and mechanical test data were performed to support the indications for use." However, it does not provide specific details about the acceptance criteria or the actual results of these tests, nor does it detail a study proving the device meets these criteria.

Therefore, for almost all points requested in the prompt, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of acceptance criteria and the reported device performance:

• Not Available. The document states that "Biological and mechanical test data were performed to support the indications for use," but it does not specify what those acceptance criteria were or what the reported performance was.

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

• Not Available. The document mentions "biological and mechanical test data" but does not provide any details about the sample sizes used or the provenance of the data (country of origin, retrospective/prospective).

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

• Not Applicable/Not Available. This information typically pertains to studies involving human interpretation or clinical outcomes, which are not detailed here. The tests mentioned are "biological and mechanical," suggesting laboratory or bench testing.

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

• Not Applicable/Not Available. As above, this is usually relevant for studies requiring expert consensus on a subjective outcome, not for mechanical or biological bench testing.

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 surgical drill, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a surgical drill.

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

• Not Available. The document states "Biological and mechanical test data were performed," implying the ground truth would be based on established biological (e.g., biocompatibility standards) and mechanical (e.g., wear resistance, cutting efficiency standards) testing methodologies. However, the specific types of ground truth (e.g., specific ASTM standards, ISO standards) are not mentioned.

8. The sample size for the training set:

• Not Applicable. This device is a physical surgical tool and does not involve AI/machine learning, so there is no training set in the conventional sense.

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

• Not Applicable. As above, no training set for this type of device.

Summary of available information regarding performance:

• The manufacturer states: "Biological and mechanical test data were performed to support the indications for use."
• The device's intended use is "to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool."
• The comparison table lists characteristics of the new device against a predicate device, noting differences in "Coating" (Amorphous Diamond vs. Titanium Nitride) and "Cutting Flutes" (Three vs. Two). This implies that the biological and mechanical tests would focus on these differing characteristics relative to the predicate device to demonstrate substantial equivalence, particularly concerning corrosion resistance and longevity.

Conclusion:

While the document confirms that performance data were generated, it does not provide the specific details regarding acceptance criteria, study methodology, sample sizes, or results that your prompt requests. This level of detail is typically found in the predicate device's 510(k) or in external reports, not always summarized comprehensively in the 510(k) notification itself during the initial submission.

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