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The BioHorizons O-Ring Abutment System is intended to provide a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.

The O-ring Abutment System is either a one-piece or a two-piece restorative prosthesis that provides a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.

This document describes a 510(k) submission for the BioHorizons O-Ring Abutment System, a Class III medical device. The submission focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel performance criteria through extensive clinical trials. Therefore, the information provided below will reflect this specific regulatory pathway.

Acceptance Criteria and Device Performance

The provided document does not specify quantitative acceptance criteria with corresponding reported device performance metrics in the format of a typical performance study for AI/software devices. Instead, the "acceptance criteria" can be inferred from the regulatory requirement of demonstrating substantial equivalence to predicate devices, and the "reported device performance" is a qualitative affirmation of meeting the stated intended use.

Inferred "Acceptance Criteria" and "Reported Device Performance" from the 510(k) Summary:

Study Information

The provided document describes a 510(k) premarket notification for a Class III device, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to establish novel performance metrics against pre-defined acceptance criteria with quantified results like sensitivity/specificity for AI/software.

Based on the provided text, the "study" conducted was primarily a product evaluation focused on demonstrating that the device meets its stated intended use and is substantially equivalent to existing predicate devices.

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

   • Sample Size: The document does not specify a quantifiable "test set" sample size in terms of number of patients or abutments. The evaluation involved "laboratory conditions" and feedback from "consulting implantologists and oral and maxillofacial surgeons." This suggests a qualitative, rather than quantitative, assessment related to real-world usage and expert opinion.
   • Data Provenance: Not explicitly stated, but the evaluation by "consulting implantologists and oral and maxillofacial surgeons" implies a clinical context, likely within the US given the submission to the US FDA. The evaluation would have been prospective in nature, as it involved evaluating the new device.

2. 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: The document refers to "consulting implantologists and oral and maxillofacial surgeons" (plural), indicating more than one expert. A specific number is not provided.
   • Qualifications: "Implantologists and oral and maxillofacial surgeons" are highly qualified clinical specialists in the field of dental implants and associated prosthetics. Their experience level is not specified.

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

   • The document does not describe a formal adjudication method for ground truth establishment, which is typical for qualitative evaluations in 510(k) substantial equivalence submissions for mechanical devices. The phrase "and has been found" suggests a consensus or agreement among the evaluators, rather than a structured adjudication process.

4. 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:

   • No MRMC study was done. This is a mechanical medical device (dental abutment), not an AI/software device. Therefore, a multi-reader, multi-case comparative effectiveness study with or without AI assistance is not applicable and was not performed.

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

   • Not applicable. This device is a mechanical component (an abutment for dental implants) and does not involve any algorithms or AI. "Standalone performance" in the context of AI does not apply here.

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

   • The "ground truth" was established through expert consensus/opinion by "consulting implantologists and oral and maxillofacial surgeons" combined with laboratory conditions (likely bench testing or mechanical evaluations). The goal was to confirm the device's ability to perform its intended mechanical function.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device. Therefore, there is no "training set" in the conventional sense. Device design and development are based on engineering principles and preclinical testing, not on data training.

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

   • Not applicable. As there is no training set for an AI/machine learning model, this question is irrelevant to the BioHorizons O-Ring Abutment System.

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The Lifecore Sustain and Restore Dental Implant Systems are intended for use in either partially or fully edentulous mandibles or maxillae in the following areas:

• Support of fixed (cemented) restorations utilizing multiple abutments; .
• Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; ●
• Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona or hader bar;
• Terminal or interniedlate abutment support for fixed bridgework; .
• Free standing restorations without involvement of adjacent dentition.

The abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The abutment is used as an attachment solution to overdentures.

This document is a 510(k) summary for the Lifecore O-Ring Abutment and Lifecore Dalla Bona Abutment, overdenture abutments used with endosseous implants. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/Software as a Medical Device submission would.

Based on the provided text, the device is a physical medical device (dental abutment) and the submission is a premarket notification (510(k)) seeking clearance for substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and does not raise new questions of safety and effectiveness.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, ground truth, and AI performance metrics is not available in the provided document.

However, I can extract what is explicitly stated about the basis for market clearance, which effectively serves as the "proof" for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal, quantitative acceptance criteria or detailed performance metrics in the way a software or diagnostic device would.
Instead, the "acceptance criteria" for a 510(k) in this context are based on demonstrating "substantial equivalence."

2. Sample Size used for the test set and the data provenance: Not applicable. This submission is based on demonstrating substantial equivalence to a predicate device through description of technological characteristics, not on a clinical "test set" in the context of performance evaluation.

3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth as typically understood for diagnostic or AI devices is not part of this 510(k) submission for a physical implant accessory.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. It is a 510(k) submission for a physical device, not an AI or diagnostic tool requiring such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.

7. The type of ground truth used: Not applicable in the context of clinical performance data. The "ground truth" for this submission is the established safety and effectiveness of the predicate device(s) through their prior market clearance and historical use.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided text is a standard 510(k) summary for a physical medical device (dental abutments). It seeks market clearance by demonstrating substantial equivalence to already cleared predicate devices. The "study" proving the device meets the (implicit) acceptance criteria is the comparison of its technological characteristics and intended use to those of legally marketed predicate devices, and the conclusion that no new questions of safety or effectiveness are raised. There are no performance data, clinical trials, or AI-related metrics discussed because the device, and the regulatory pathway chosen, do not require them.

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