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The Inclusive Titanium Abutments for Camlog Screw-Line Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the CAMLOG Screw-Line Implants in 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.

The Inclusive® Titanium Abutments for Camlog Screw-Line Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. These abutments are made of titanium grade Ti-6AL-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. These abutments are compatible with the CAMLOG Screw-Line Implants as follows: 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.

This document describes the non-clinical testing for the Inclusive Titanium Abutments for Camlog Screw-Line Implants. It focuses on demonstrating substantial equivalence to a predicate device through mechanical performance testing rather than clinical study. Consequently, information typically associated with clinical studies, such as multi-reader multi-case studies, ground truth establishment for clinical endpoints, or human reader performance, is not applicable or provided.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical performance testing. It states that "All testing conducted met the acceptance criteria and evaluated the worst-case scenario," implying sufficient testing was performed to cover relevant configurations and conditions.
• Data Provenance: The data provenance is from laboratory mechanical testing. This is a non-clinical study, not directly tied to a specific country of origin for patient data. It is inherently retrospective as the testing has already been completed.

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

• This question is not applicable as the study is a non-clinical mechanical performance study rather than a study with human subject data requiring expert ground truth for clinical outcomes. The "ground truth" here is the adherence to established engineering standards (ISO 14801, ISO 14971, ANSI-AAMI ST79-2006).

4. Adjudication Method for the Test Set

• This question is not applicable as the study is a non-clinical mechanical performance study. Adjudication methods are typically employed in clinical trials to resolve discrepancies in expert assessments of clinical endpoints.

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. The device is a physical dental implant component, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study involving human readers with or without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. The device is a physical dental implant component, not an algorithm or software.

7. The Type of Ground Truth Used

• The "ground truth" for this non-clinical study is defined by established engineering and medical device standards:
  • Mechanical Performance: ISO 14801: 2007 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
  • Mechanical Compatibility: ISO 14971 - Dynamic fatigue test for endosseous dental implants.
  • Sterilization Validation: ANSI-AAMI ST79-2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
  • Design Conformance: Conformance to design input and parameters determined by reverse engineering of existing, approved devices.

8. The Sample Size for the Training Set

• This question is not applicable as the study is a non-clinical mechanical performance study and does not involve AI or machine learning that requires a "training set" of data.

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

• This question is not applicable for the reasons stated in point 8.

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