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Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations.

The GM Titanium Base for Bridge are prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Titanium Base for Bridge is a two-piece abutment used as a base when fabricating a CAD/CAM customized restoration. The planning and milling of the customized superstructures should be made using the validated Dental Wings Operating System (DWOS) or 3Shape Software. All digitally designed copings and/or crowns for use with the GM Titanium Base for Bridge are intended to be manufactured as a validated milling center. The limits for customization are stated in the GM Titanium Base for Bridge Instructions for Use. The superstructure produced through the CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Titanium Base for Bridge.

The main characteristics of the subject devices are the following:

• Intended for single use;
• Provided sterile via ethylene oxide gas;
• Manufactured of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
• Conical format available in different diameters, height of cementable area and gingival height;
• Screw-retained;
• Provided in rotational (non-indexed) version supporting multi-unit restorations;
• Provided with an implant-to-abutment interface compatible with the GM implants of the Neodent Implant System.

The provided text describes a 510(k) premarket notification for the "Neodent Implant System - GM Titanium Base for Bridge" and includes performance data to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria for an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission, as it concerns a dental implant abutment and not an AI/ML system.

However, I can extract the relevant performance data and acceptance criteria mentioned for the dental device.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not applicable:

Acceptance Criteria and Device Performance for Neodent Implant System - GM Titanium Base for Bridge

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Dynamic Fatigue Test: Not explicitly stated but mentions "worst-case implant construct assembled with GM Titanium Base for Bridge," and "tested with three different restoration materials." The exact number of each construct tested is not provided.
• Torsion Testing: Not explicitly stated, but performed to evaluate "Titanium Base Screws."
• Data Provenance: Not specified, but the sponsor is "JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent)" based in Curitiba, Parana, Brazil. The testing appears to be lab-based performance testing rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a physical dental implant abutment, and its performance is evaluated through engineering and biocompatibility testing, not expert interpretation of outputs like an AI/ML system.

4. Adjudication method for the test set:

• Not applicable. See #3.

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. This is a physical device, not an AI/ML system, so no human reader studies were conducted.

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

• Not applicable. This is a physical device.

7. The type of ground truth used:

• For the physical device, the "ground truth" is defined by industry standards (e.g., ISO 14801, ISO 11135, ISO 10993 series) and internal engineering specifications for mechanical strength, biocompatibility, and sterility. The results of the laboratory tests directly provide this "ground truth" data against the specified criteria.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set."

Summary of the Study:

The studies conducted for the Neodent Implant System - GM Titanium Base for Bridge were primarily laboratory-based performance tests to assess its mechanical properties (dynamic fatigue, torsion), sterilization efficacy, and biocompatibility. These tests were conducted according to recognized international standards (ISO 14801, ISO 11135, ISO 10993 series) and FDA guidance, demonstrating that the device meets the established acceptance criteria for its intended use as a dental implant abutment. The purpose of these studies was to show substantial equivalence to a previously cleared predicate device (K180536), indicating that the new device is as safe and effective as the predicate.

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