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The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.

The 3A Dental Implant System is a CP titanium implant that are self-tapping or standard screw-type design. The implant body has a surface finish for either smooth (bright) or The implants are available in various insertion lengths and textured (abrasive blasted). diameters

The provided text describes a 510(k) premarket notification for the 3A Dental Implant System, which is a Class III medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a novel AI/software device. Therefore, much of the requested information regarding AI device testing is not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically defined for AI/software devices (e.g., in terms of sensitivity, specificity, AUC) is not present in this 510(k) submission. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to legally marketed predicate devices. The "reported device performance" is described in terms of material properties and design similarity, and functional testing to assure safety and efficacy.

2. Sample Size Used for the Test Set and Data Provenance

The text refers to "samples of titanium" used for testing, but it does not specify the sample size. The testing appears to be primarily mechanical/materials testing rather than clinical data from a "test set" in the context of an AI study.
Data provenance is not described in terms of country of origin or retrospective/prospective data collection because it's not a clinical study involving patient data. The testing was laboratory-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI/software device that requires expert adjudication for ground truth. The "ground truth" for a dental implant would be its physical and mechanical properties and its performance in a laboratory setting under simulated conditions, compared against established engineering standards or the performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of device (a dental implant). The device is not an AI or imaging diagnostic tool that would involve human readers.

6. If a Standalone Study Was Done

A form of standalone testing was done in the sense that the device itself (or "samples of titanium" representing it) underwent testing. The text states: "Testing of a 'typical' or representative, standard system configuration utilizing an 'angled abutment' was conducted on samples of titanium." This appears to be laboratory bench testing rather than a clinical trial.

7. The Type of Ground Truth Used

The ground truth for this device is based on engineering specifications, material science, and functional performance testing (e.g., strength, durability, biocompatibility) of the titanium samples and the integrated system. The ultimate "ground truth" for substantial equivalence is the existing safety and efficacy profile of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

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