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The Dentis Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

The Dentis Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage for single and multiple unit prosthetics. The Dentis Dental Implant System consists of machined titanium, screw-form dental implant Ø 3.5mm. Ø 3.7mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm, Ø 5.5mm, 6.0mm in diameter. They are available in length of 7-14 mm. The implant's raw material is titanium and its alloys for surgical implant applications (as per ASTM-F-67, ASTM-F-136). Surfaces include as machined surfaces, grit blasted and surfaces treated with Resorbable Blast Media (RBM) roughened surface. The System includes surgical instruments such as twist drill, bone tap, Trephine

The provided text describes the Dentis Dental Implant System and its 510(k) submission, confirming its substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, device performance metrics, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about MRMC or standalone studies.

The "Performance" section explicitly states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates that performance testing was done, but the details of these tests, including the criteria and results, are not provided in this summary.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or answer the other specific questions about the study design, ground truth, or expert involvement based on the provided text alone. The document focuses on regulatory equivalence and device description rather than detailed clinical or performance study results.

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