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The Inclusive® Titanium Abutments 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 Straumann Standard Plus Tissue Level Implants in RN (4.1mm and 4.8 mm) and WN (4.8 mm) sizes.

Inclusive® Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. Prismatik Dentalcraft. Inc. provides premanufactured titanium abutments of a stock type with no inherent angulation which require further modification to obtain the desired shape before being used. The modifications are intended to be performed by dental laboratories with laboratory hand tools, as delineated in the device's instructions for use.

This document describes a 510(k) premarket notification for Inclusive® Titanium Abutments compatible with the Straumann synOcta Implant System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the same way a de novo or PMA submission might.

Therefore, the information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not explicitly present in the provided text. The document employs a different regulatory strategy, relying on demonstrating that the new device is as safe and effective as devices already on the market through comparison and non-clinical testing.

Here's an analysis based on the available information, noting where specific requested details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of explicit acceptance criteria with numerical targets and reported performance in the way a clinical trial or performance study would. Instead, substantial equivalence is demonstrated through a comparison table of attributes (Indications for Use, Dimensions, Connection, Sterility, Material, Abutment Angle, Abutment Seat, Screw Seat, Anatomical Site, Construction) where the proposed device is shown to be similar to legally marketed predicate devices.

The "reported device performance" is summarized by the outcome of non-clinical testing, which aimed to show implant-to-abutment compatibility and substantial equivalence, rather than meeting specific performance metrics against pre-defined acceptance criteria.

Summary of Comparative Attributes (from pages 6-7):

Study Details:

The study referenced is a non-clinical "Performance Data" study (Section G).

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: Not explicitly stated. The document refers to "testing finished assembled implant/abutment systems of the worst case scenario," implying a limited number of samples chosen to represent the most challenging conditions rather than a statistically powered test set sample size.
• Data Provenance: Not specified, but generally, such non-clinical testing would be conducted in a laboratory setting by the manufacturer (Prismatik Dentalcraft, Inc.), which is based in Irvine, California, USA. It is prospective testing designed to evaluate the physical properties of newly manufactured components.

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)

• Number of Experts & Qualifications: Not applicable for this type of non-clinical, substantial equivalence submission. Ground truth in this context typically refers to objective material properties, mechanical integrity, and compatibility, which are established through standardized engineering tests rather than expert consensus on medical images or clinical outcomes.

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

• Adjudication Method: Not applicable. Non-clinical mechanical testing does not involve adjudication. Results are typically determined by direct measurement and adherence to specifications or established test methods (e.g., ASTM 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

• MRMC Study: No. This submission is for a physical medical device (dental abutments), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: For the non-clinical testing, the "ground truth" would be objective measurements derived from mechanical tests, such as fatigue strength, static load failure, and dimensional compatibility, compared against established engineering standards (e.g., ASTM F136 for material, and potentially other ISO or FDA recognized standards for dental implants/abutments). The document explicitly states testing was "in accordance with FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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