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Intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

The EBI Internal Implant system is a threaded, root form endosseous implant comprised of an internal octagon, 8° morse tapered device manufactured from pure Titanium ASTM F-67 and the Abutment from Titanium 6A-4V alloy E 11 -ASTM 136. The implant's external threaded surfaces are roughened to facilitate tissue and bone integration. The implant's self-tapping feature may be used with or without pre-tapping the bone. System components for restorative purposes include: screw retained and cement retained abutments, cover screws, healing abutments, and angled abutments.

The provided text describes a 510(k) premarket notification for the "EBI Internal Implant System," a dental implant device. This type of submission focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting new clinical studies with specific acceptance criteria and performance metrics in the way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study cannot be found in this document.

The core of this submission is a comparison to predicate devices to demonstrate that the EBI Internal Implant System is substantially equivalent. The "study" here is essentially a technical characteristics comparison to existing, legally marketed dental implants.

Here's how the information provided relates to your questions, and what is explicitly not available:

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

• Not Applicable in the traditional sense for this 510(k) submission. This document does not present specific quantitative performance metrics or acceptance criteria for a new clinical study. Instead, it compares the technical characteristics of the EBI Internal Implant System to two predicate devices (AVANA Dental Implant System K051576 and ITI Dental implant system K003552).
• The "performance" section states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug, and Cosmetic Act." This further reinforces that the submission is not based on a new performance study with FDA-defined acceptance criteria.

Instead, a table of comparative technical characteristics is provided:

Conclusion from the document: "In all respects, the EBI Internal Implants components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products listed in the table above."

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

• Not applicable. No test set or clinical study data is presented. The submission relies on establishing substantial equivalence through comparison of technical features to 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. No ground truth or expert review process for a test set is mentioned.

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

• Not applicable. No adjudication method is described as there is no test set or expert review.

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 medical device (dental implant) without AI components. Therefore, no MRMC or AI-assisted study was performed.

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

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

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

• Not applicable. "Ground truth" in the context of clinical performance data is not presented. The basis for equivalence is the proven track record and regulatory acceptance of the predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of device submission.

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

• Not applicable. No training set exists for this submission.

In summary, the provided text is a 510(k) summary for a dental implant. This regulatory path focuses on demonstrating similarity to existing devices, not on generating new clinical performance data with specific acceptance criteria, test sets, or expert review, which would typically be seen for novel devices or AI/ML technologies.

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