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The Star/Vent Internal Hex Screw Implant is intended for placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in edentulous or partially edentulous patients and to restore the patient's chewing function. It is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading,

The Park Star/Vent Internal Hex Screw Implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per 21 CFR 872.3640. The device is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 11.5, 13, and 16mm and diameters of 3.3, 3.75, 4.2, 5.0 and 6.0mm. The surface is treated with resorbable blast media. The device is provided sterile. Sterility is achieved by gamma radiation pursuant to ISO 11137 to provide a sterility assurance level (SAL) of 10-. This device includes straight abutments with a 1, 2, 3, or 4mm collar and a straight UCLA cast abutment with a titanium base. These abutments are composed of titanium alloy meeting the specifications of ASTM F-136.

The provided text is a 510(k) summary for a dental implant device (K082800). It focuses on establishing substantial equivalence to predicate devices based on material composition, implant dimensions, surface treatment, and indications for use.

Crucially, this document does not contain information about acceptance criteria for device performance studies, nor does it detail any studies conducted to prove the device meets specific performance criteria.

A 510(k) summary for a device like a dental implant typically demonstrates substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria. The FDA determined that the device is substantially equivalent based on the provided information, meaning it performs as safely and effectively as previously cleared devices.

Therefore, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, study details, ground truth, or sample sizes, as this information is not present in the provided text.

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