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The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

The Steri-Oss implant is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The implants are 6 mm in diameter, from 8 -They are 18 mm in length and are composed of titanium. available with a flat or hex lock superior surface, and are either cylindrical or threaded.

This document is a 510(k) summary for a medical device (Steri-Oss 6 mm Diameter TPS Coated Implants) and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML system.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details. This type of information is typically found in submissions for AI/ML-powered diagnostic or assistive devices, which is not what this document describes.

The performance data section in this document states: "A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products." This refers to demonstrating that the new implant is as safe and effective as an existing, legally marketed implant (the predicate device), rather than a study with acceptance criteria for a specific performance metric like accuracy or sensitivity for an AI system.

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