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The Maestro System™ may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention. The Indication/Intended use of the modified device, the Maestro System™, as described in its labeling has not changed.

The 15 mm length Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 3.5 mm , 4.0 mm and 5.0 mm, and in lengths of 9 mm, 12 mm, and15 mm. The implant raw material is titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications.

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

The Maestro System ™ is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This is achieved by optimizing implant designs based on bone quality.

Following four years of clinical use, this submission proposes altered sizing to assist the dental practitioner in treatment planning and ease of use with the product. Three base implant designs, corresponding to each bone density classification (D1/D2, D3 and D4) will be available in 3.5 mm, 4.0 mm and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, will be available in three lengths and may feature a Resorbable Blast Media (RBM) surface treatment, or hydroxylapatite (HA) coating.

This document is a 510(k) premarket notification for a medical device called "The Maestro System™," a screw-type dental implant. The purpose of this submission is to introduce altered sizing for existing implants and reintroduce a 15mm length implant. It claims substantial equivalence to previously cleared Maestro System implants.

Based on the provided information, there is no study described that demonstrates and provides acceptance criteria for device performance based on objective measures, such as a diagnostic accuracy study. The entire submission focuses on establishing substantial equivalence to previously cleared predicate devices through similarities in design, material, and intended use, rather than presenting a performance study with specific acceptance criteria.

The acceptance criteria for this 510(k) submission are implicitly tied to the concept of substantial equivalence to the predicate device. This means the device must be demonstrated to be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Here's an analysis of the provided information in the context of your request, explicitly noting where information is not available in the document:

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)

• Not applicable / Not provided. This document does not describe a performance study with a test set. The submission relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices.

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)

• Not applicable / Not provided. There is no test set or ground truth described in this submission.

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

• Not applicable / Not provided. There is no test set or adjudication method 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

• Not applicable / Not provided. This device is a physical dental implant, not an AI software. Therefore, an MRMC study related to human readers and AI assistance is entirely outside the scope of this submission.

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

• Not applicable / Not provided. This device is a physical dental implant, not an algorithm or software. No standalone performance study for an algorithm is relevant here.

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

• Not applicable / Not provided. No specific "ground truth" for a performance study is mentioned. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate devices based on their legal marketing history and previous FDA clearances.

8. The sample size for the training set

• Not applicable / Not provided. There is no training set described. This is not a machine learning or AI device.

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

• Not applicable / Not provided. As there is no training set, this information is not relevant.

Summary of the "Study" (Implicit)

The "study" presented in this 510(k) is a comparative analysis against predicate devices to demonstrate substantial equivalence. It's not a clinical trial or a performance study with a test set in the traditional sense you might expect for a diagnostic or AI device. The evidence for "meeting acceptance criteria" is the comprehensive argument that the modifications to the Maestro System do not raise new questions of safety or effectiveness when compared to the already cleared versions of the Maestro System. The FDA's decision to clear the device (K020133) indicates that they accepted this argument for substantial equivalence.

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