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The XL Dental Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This XL implant system provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This submission includes threaded root-form dental implants with large diameter for use in the molar region. The implants are provided in diameters of 7, 8 and 9mm and lengths of 7, 9 and 11mm. This submission also includes mating components: Cover screws; Healing Abutments in varying diameters and cuff heights; Titanium Cylinder abutments for temporary restorations; Titanium Abutments in varying diameters and cuff heights for permanent restorations; and the abutment screw.

The XL implants are manufactured from titanium alloy conforming to ASTM F136. The implants have a is grit blasted, acid etched (SLA) surface. The Cover Screw, Abutments and Abutment Screw are manufactured from titanium alloy conforming to ASTM F136.

The provided text is a 510(k) Premarket Notification from the FDA for the Keystone Dental XL Dental Implant System. It discusses the device's administrative information, indications for use, device description, performance data, and a comparison to legally marketed predicate devices to demonstrate substantial equivalence.

However, it does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.

The document details non-clinical performance data for physical characteristics of the dental implant (sterilization validation, biocompatibility, bacterial endotoxin testing, modified surface analysis), and relies on established standards (ISO, ASTM, FDA guidances) and substantial equivalence to predicate medical devices for these aspects. There is no mention of an "algorithm" or "AI assistance" in this document.

Therefore, I cannot extract the requested information as it is not present in the provided text. The device being reviewed is a physical implant, not an AI/ML-based diagnostic or therapeutic tool.

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