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BioHorizons endosseous dental implants may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

Device Description

The BioHorizons Ceramic Abutment is a prosthetic restorative component intended for use with BioHorizons dental implants. This 510(k) submission notification is for the purpose of obtaining authorization to offer ceramic prosthetic abutments as part of endosseous implant systems manufactured and marketed by BioHorizons. The abutments are manufactured from ceramic material to BioHorizons design specifications, similar to the predicate Astra Tech device, and will be provided with a mating abutment screw for attachment to the implant.

In clinical practice the surgical placement and restorative procedures for the implants and abutments will not change. Ceramic abutments offer clinicians an esthetic treatment option with the more natural color tint of the ceramic when visible through gingival tissue, compared with the gray tint of titanium abutments.

AI/ML Overview

The provided text describes a 510(k) submission for BioHorizons Ceramic Abutments. This submission focuses on demonstrating substantial equivalence to predicate devices for a physical medical device, not a software algorithm or AI-powered solution. Therefore, the questions related to AI-specific performance criteria, ground truth, expert review, training sets, and MRMC studies are not applicable to this document.

The "acceptance criteria" in this context refer to the device's functional performance and conformance to design requirements through non-clinical laboratory testing, rather than a diagnostic accuracy or efficacy evaluation for an AI model.

Here's the relevant information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Requirement	Reported Device Performance (from "Non-Clinical Testing")
Device functionality	Laboratory testing was conducted on the "worst cast" (because of lesser wall thickness) 4.5mm Ceramic Abutment to determine device functionality. (Implied: functionality was met, otherwise it wouldn't have passed the 510(k) process for substantial equivalence).
Conformance to design requirements	Laboratory testing was conducted on the "worst cast" (because of lesser wall thickness) 4.5mm Ceramic Abutment to determine conformance to design requirements. (Implied: conformance was met).

Note: The document does not provide specific numerical values or detailed results from the laboratory tests. It only states that testing was conducted to determine functionality and conformance. In a 510(k) for a physical device like this, the "acceptance criteria" are often met by demonstrating that the device performs as intended and is safe and effective when used as described, typically through mechanical testing, biocompatibility, and sterilization validation, which aren't detailed here but are standard for such devices.

The following questions are not applicable to this document as it pertains to a physical medical device submission (dental abutment), not an AI/software as a medical device (SaMD).

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader multicase (MRMC) comparative effectiveness study was done
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

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