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BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection can be compared to current Encode Patient Specific abutments. The change to this device is only to the connection that is intended to interface which is identical to the interface found on the Nobel Replace HA Coated Implant. This feature does not modify the intended functionality of the implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient. Maximum angulation for the abutment is limited to 15°.

The provided document (K110565) describes a traditional 510(k) premarket notification for a medical device called "BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study for novel performance claims.

Based on the information provided, here's what can be extracted and what is not present:

1. Table of acceptance criteria and reported device performance:

The document states: "Performance testing was conducted as per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Performance testing was based on a comparison between proposed and predicate implant/abutment systems. The results were equal or better than established acceptance criteria, where predicate testing was used as a baseline."

This indicates that acceptance criteria were established and met, but the specific numerical criteria and the quantitative reported device performance are not detailed in this summary. Instead, it refers to a "comparison between proposed and predicate implant/abutment systems" and implies meeting established baselines.

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

This information is not provided in the document. The document mentions "Performance testing was conducted," but it doesn't specify the number of samples used for this testing or the origin of any data (e.g., country of origin, retrospective/prospective).

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

This information is not applicable and not provided for this type of device submission. This device is a mechanical abutment, not an AI/software device that requires expert ground truth for interpretation or diagnosis. The performance evaluation would involve engineering and material testing, not clinical expert review for diagnostic accuracy.

4. Adjudication method for the test set:

This information is not applicable and not provided. As above, this is a mechanical device, not an AI/software product requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging or AI systems where human readers interpret cases. This device is a physical dental abutment.

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

This information is not applicable and not provided. This device is a physical product, not an algorithm, so "standalone performance" in the context of AI is not relevant.

7. The type of ground truth used:

For this device, the "ground truth" would be established through engineering and materials testing standards (e.g., fatigue testing, static load testing, dimensional accuracy measurements) as per the "Class II Special Controls Guidance Document." It relies on objective, measurable physical properties and mechanical performance, not expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices. The acceptance criteria themselves serve as the definition of acceptable "truth" for performance.

8. The sample size for the training set:

This information is not applicable and not provided. This is a physical device, not an AI model, so there is no "training set."

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

This information is not applicable and not provided. There is no "training set" for this physical device.

In summary:

The provided document describes a 510(k) submission for a dental abutment, demonstrating substantial equivalence to predicate devices primarily through performance testing based on established guidance documents. It does not contain the detailed information typically found in AI/software device submissions regarding acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or human-in-the-loop studies. The "study" here refers to engineering performance testing against regulatory guidance and predicate device baselines, not a clinical study with human readers or AI algorithms.

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