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The ACE Surgical Secure-Mini™ Locator® Implant System is is designed to provide immediate transitional splinting stability or intra-bony long term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients.

The ACE Secure-Mini™ Locator® Implant System is an additional set of machined surgical grade titanium alloy (Ti-6A1-4V ELI) screw implants to the Secure-Mini™ product family, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of the 10, 11.5, 13, and 15 mm, and with Zest Locator® Implant Anchor Abutments (cleared under K994257) and Denture Cap Males (cleared under K072878) in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics to that cleared under K073343. These screws are supplied sterile in standard Tvvek™ travs. The ACE Surgical Secure-Mini™ Locator® Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Secure-Mini™ Implant system.

The provided document is a 510(k) summary for a medical device (ACE Surgical Secure-Mini™ Locator® Implant System) seeking substantial equivalence to existing predicate devices. It focuses on demonstrating equivalence through device description, indications for use, materials, bench test results, and labeling, rather than presenting a detailed clinical study with acceptance criteria and performance metrics for a new AI-powered diagnostic device.

Therefore, most of the requested information regarding acceptance criteria, study design elements for AI performance (like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details), and ground truth establishment is not available in the provided text.

The document states: "In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Secure-Mini™ Locator® Implant System and the specified predicate devices." This implies that the 'acceptance criteria' were met by demonstrating non-inferiority or equivalence to the predicate devices through bench testing. However, the exact quantitative acceptance criteria and the detailed results of these bench tests are not provided.

Here's a breakdown of what can be extracted and what is not available:

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

2. Sample size used for the test set and the data provenance: Not applicable. This was a bench testing study, not a study involving patient data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic AI sense was established by experts; rather, the performance was assessed relative to predicate devices through engineering/bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic AI. The "ground truth" for the bench testing would be established engineering standards or the performance of the predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI-powered device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

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