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Removable Cuff Abutments are screw retained endosseous dental implant abutments and are intended to function as an anchor to which prosthetic devices may be attached using either dental oement or a lingual screw.

They are indicated for use on endosseous implants placed in the mandible or maxilla for support of fixed bridgework, removable bridgework or free standing single tooth replacements.

A Removable Cuff Abutment is a two piece titanium alloy abutment with a separate titanium alloy retaining screw. Each Removable Cuff Abutment is composed of one abutment core body and one removable cuff. Removable Cuff Abutments will be offered as fixed abutments and as pre-angled (15 and 25 degree) abutments for use with both cement and screw retained prosthetics. Abutments will be available in three different diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Flare diameters of cuffs will range from 4.0 to 6.5mm and cuff heights will range from 0.5 mm. A new feature is the addition of a transverse (lingual) screw to some designs. This feature will permit attachment of screw retained prostheses in addition to cement retained prostheses. Removable Cuff Abutments will be packaged with or without the transverse (lingual) screw components.

The provided text is a 510(k) summary for a dental implant abutment and does not contain information about an AI device or a study involving acceptance criteria and device performance as typically understood for AI/ML medical devices. The document describes a "Removable Cuff Abutment" and its comparison to predicate devices, focusing on manufacturing, material, and design characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these are not discussed in the provided text.

The section titled "Performance Data" states: "Bench top testing demonstrated the equivalence of the Removable Cuff Abutment to the predicate devices." This is the only mention of performance or testing, and it refers to physical bench testing, not an AI model's performance.

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