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The ACE Surgical Secure™ Locator® 3.25mm Implant System is is designed to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients.

The ACE Secure™ Locator® 3.25mm Implant System is a set of machined commercially pure (CP) titanium (Grade 4) screws, intended to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients. The implants are supplied sterlie in 3.25 mm diameter, and in lengths of 8, 10, 11.5, 13, and 15 mm, and with Zest Locator® implant Anchor Abutments and Denture Cap Males (Identical to those cleared under K092594)/n standard tray packaging and include placement instruments.

The screw raw material is Ti (CP-Grade 4) per ASTM F67 standard. The screw Implants, abutments and denture caps are identical In materials and characteristics to that cleared under K092594 and K954513. These screws are supplied sterile in standard Tyveke tray packaging along with applicable instructions for use.

The ACE Secure™ Locatore 3,25mm Implant System Is a comprehensive system using same and similar surgical tools (a Two Step Lag Bur CA is replaced by a Kirschner Pliot Bur, and the optional Parallel Pin/Depth Gauge and 2.8 mm twist drill are now supplied standard) made from high strength corrosive resistant stainless steel (17-4, H-900) and a similar (the predicate tray had holes and markings to accommodate the predicate screw implant sizes, the candidate device will have two trays - one solely for candidate screw implant sizes, and another for the combined predicate and candidate screw implant sizes) polycarbonate sterlization tray accessory as in the predicate ACE Surgical Secure-Mini™ Locator® Implant svstem.

The provided text describes a submission for a 510(k) premarket notification for a dental implant system. The focus of this submission is to demonstrate substantial equivalence to previously marketed predicate devices, rather than conducting a de novo study to establish acceptance criteria based on new performance data.

Therefore, the acceptance criteria and study information typically sought for a new device's performance evaluation (such as those involving AI or diagnostic accuracy) are not present in this document. The "acceptance criteria" here implicitly refer to the demonstration of equivalence to existing, legally marketed devices.

Here's an analysis based on the provided text, addressing your questions where applicable, and highlighting where information is not available:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a bench testing study, not a clinical trial or a study assessing AI performance.

1. Sample size used for the test set and the data provenance: Not applicable in the context of this 510(k) submission. The "test set" here refers to components undergoing bench testing rather than a dataset for an AI model. The document does not specify the number of implants or components tested during bench testing, nor their provenance. The "data provenance" would relate to the manufacturing and testing environment for the physical components.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For bench testing comparing physical device characteristics and performance, "ground truth" would be established by scientific and engineering measurements against established standards or predicate device specifications, not typically by expert consensus in the way clinical diagnostic ground truth is formed.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI algorithm evaluations to resolve discrepancies in expert opinions for ground truth establishment. This is a bench testing scenario.

4. 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 submission is for a physical medical device (dental implant system), not an AI/ML-driven diagnostic or assistive device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench testing described, the "ground truth" implicitly relies on engineering standards (e.g., ASTM F67 for titanium raw material) and direct comparison to the physical and functional characteristics of the predicate devices. The goal was to show identical or similar performance.

7. The sample size for the training set: Not applicable. This is not an AI/ML algorithm.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML algorithm.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence to predicate devices through a comparison of device description, materials, intended use, and bench test results. It does not involve the types of studies typically conducted for AI/ML-based devices or devices requiring extensive clinical performance data beyond comparisons to existing, cleared products.

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