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The BioHorizons Maestro System 3.0 mm Diameter Implant may be used

• (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
• (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.
• (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.

The BioHorizons Maestro System 3.0mm diameter dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The device is further processed by treating the surface with resorbable blast media (RBM). The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10 °, validated in compliance to ANSI/AAMI/ISO 11137, Sterlization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

The Maestro System™ 3.0mm Diameter Implant is a comprehensive system containing implants and surgical components.

This document is a 510(k) summary for a dental implant, not a study report for a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and adjudication methods is not present in the provided text.

Based on the provided text, here is what can be extracted and what cannot:

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

• Cannot be provided. The document describes a medical device (dental implant) and its substantial equivalence to predicate devices for regulatory clearance. It does not detail specific acceptance criteria or performance metrics in the way a clinical or technical performance study would. It focuses on the device's characteristics and intended use.

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

• Cannot be provided. This document is not a study report. It does not mention any test sets, sample sizes, or data provenance.

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)

• Cannot be provided. No ground truth establishment for a test set is mentioned in this regulatory submission document.

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

• Cannot be provided. No adjudication method is mentioned as there is no test set or study described.

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

• Cannot be provided. This device is a dental implant, not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not applicable to this submission.

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

• Cannot be provided. This device is a dental implant, not an algorithm.

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

• Cannot be provided. No ground truth is described in the context of a performance study.

8. The sample size for the training set

• Cannot be provided. This document is not about an AI device with training sets.

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

• Cannot be provided. Not applicable to this type of device and document.

Summary of what is present:

The document is a 510(k) Pre-market Notification for a dental implant, demonstrating substantial equivalence to previously cleared predicate devices. The focus is on the physical characteristics, materials, manufacturing processes, and intended use being similar to existing, legally marketed devices. The "study" here is essentially the comparison to predicate devices, asserting that its "Technological Characteristics" are "identical or very similar" and "substantially equivalent to all features of the predicate devices which could affect safety or effectiveness because of the similarities in design, material and intended use."

The regulatory body (FDA) reviewed this claim and, in the letter, indicated that the device is "substantially equivalent" for the stated indications for use. This "substantial equivalence" is the primary "acceptance criterion" for 510(k) clearance, implying that if the new device is as safe and effective as a legally marketed predicate, it can be marketed. No new clinical trials or performance studies against specific numerical acceptance criteria are detailed in this type of submission.

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