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The Implant Integration Systems Surgical Drills are intended to be used in the placement of the "Dual Integrator" Dental Implant (K944225).

This product is similar in design, composition (titanium nitrade coated stainless steel) and function to the Implant Innovations, Inc. Surgical Drills (K891615), the Impla-Med Corp. Titanium/Stainless Steel Dental Implant Drills (K902158) and the Steri-oss Drills and Taps (K915733).

The provided text describes a Surgical Drill system (Implant Integration Systems Surgical Drills) intended for use with a specific dental implant (Dual Integrator Dental Implant), and states that it is similar to other predicate devices.

However, this document is a 510(k) Summary of Safety and Effectiveness from 1996. It focuses on demonstrating substantial equivalence to pre-existing devices, which is the regulatory pathway for many medical devices in the US.

Therefore, the document does not contain any of the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, or AI-related data. The concept of "acceptance criteria" and "device performance" in the context of advanced AI algorithms, multi-reader multi-case studies, and ground truth establishment as described in your request did not generally apply to the regulatory submission for a surgical drill system in 1996.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document primarily identifies predicate devices for substantial equivalence.
2. Sample size used for the test set and the data provenance: This information is not present in the document. No test set or data studies are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
4. Adjudication method for the test set: This information is not present in the document.
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: This information is not present in the document. AI was not a factor in medical device regulation or development in this context in 1996.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not present in the document. This device is a surgical drill, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present in the document.
8. The sample size for the training set: This information is not present in the document.
9. How the ground truth for the training set was established: This information is not present in the document.

In summary, the provided document is a regulatory submission for a physical surgical tool from 1996, and the type of detailed performance criteria and study information you are asking for (which are common for AI-driven medical devices) are completely absent and not applicable to this kind of product or its regulatory pathway at that time.

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