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

The ACE Surgical Secure-Mini™ Implant System is a set of machined surgical grade titanium alloy screws, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture instally or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of 10, 11.5, 13, and 15 mm, in standard trays 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 K951392. These screws are supplied sterile in standard Tyvek™ trays. The ACE Surgical Secure-Mini™ Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.

The provided text describes a medical device, the ACE Surgical Secure-Mini™ Implant System, and its 510(k) submission for market clearance. However, the document does not include detailed information about acceptance criteria or a specific study designed to prove the device meets these criteria in the way typically expected for a diagnostic or AI-powered device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

1. Device description
2. Indications for use
3. Bench test results
4. Materials
5. Labeling

The key statement regarding performance is: "In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Prov+ Screw System and the specified predicate devices."

Given this, I cannot provide the requested information in the format of acceptance criteria and a study proving their fulfillment as the document implies a comparison study rather than a de novo performance study against defined acceptance criteria.

However, I can extract the available information as it relates to the type of assessment conducted:

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

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

• The document mentions "bench test results" but does not specify the sample size for these tests.
• Data provenance is not explicitly stated, but "bench testing" typically implies laboratory-controlled tests rather than human clinical data.

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

• This information is not applicable as the clearance is based on substantial equivalence demonstrated through bench testing, not expert-adjudicated clinical data.

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

• Not applicable, as there is no mention of expert adjudication for a test set.

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 device, nor is there any mention of a human-in-the-loop or MRMC study.

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

• Not applicable. This device is a dental implant system, not a software algorithm.

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

• The "ground truth" for demonstrating substantial equivalence relied on measurable physical and mechanical properties compared during "bench testing," and the comparison of device characteristics (materials, indications for use, design) to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not a machine learning model.

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

• Not applicable. This device does not involve a training set.

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