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The Trefoil system is used to restore chewing function in fully edentulous mandibles.

The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol.

The following prerequisites must be fulfilled:

• Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for 11.5 mm implant and 14.5mm for 13.0 mm implant).
• Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
• Implant-supported prosthetics seated directly on dedicated implants.

The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.

The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.

The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal connection. The implant is available in three diameters 4.3, 5.0, and 5.5 mm. All three diameters are available in lengths of 11.5 and 13mm and have a 4.5 mm tissue collar that has a smooth machined surface without threads. The apex of the implants has cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.

The provided document is a 510(k) premarket notification for a medical device called the "TREFOIL System," an endosseous dental implant. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new AI/software device.

Therefore, many of the requested categories for AI/software acceptance criteria and study details are not directly applicable to this document. The document describes mechanical and material testing for the dental implant system.

Below is an attempt to extract relevant information and note where the requested details are not present in this type of submission.

This document describes the TREFOIL System, an endosseous dental implant system, and its substantial equivalence to a predicate device, K152836 (also TREFOIL System). The performance data presented refers to fatigue testing and biocompatibility testing to demonstrate the device meets its design requirements and is safe for use.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the exact number of samples used for the fatigue testing or biocompatibility testing. It generally refers to "testing performed."
• Data Provenance: Not specified, but generally refers to laboratory testing performed by the manufacturer. These are bench tests, not human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable to this type of device submission. There is no human "ground truth" to establish for mechanical and material testing of an implanted medical device. The "ground truth" here is the adherence to established engineering and material science standards (e.g., ISO 14801).

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

• This question is not applicable. Adjudication methods like 2+1 are used in clinical studies, typically for diagnostic or screening devices where human interpretation is involved. For a mechanical implant device, performance is measured against objective physical standards.

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 question is not applicable. This document is for a physical medical device (dental implant system), not an AI or software device involving human readers or interpretation of medical images.

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

• This question is not applicable. This is not an algorithm or software device.

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

• The "ground truth" for this device's performance is objective measurements against international standards (e.g., ISO 14801 for fatigue testing, CEN EN ISO 10993 for biocompatibility) and comparison to the performance of the legally marketed predicate device. It is based on engineering principles and material science.

8. The sample size for the training set

• This question is not applicable. This is not an AI/machine learning device that would require training data.

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

• This question is not applicable. This is not an AI/machine learning device.

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