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Implants: OsseoLink dental implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended.

Prosthetic Abutments, Cover Screws & Healing Abutments: OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.

The OsseoLink Dental Implant System is an endosseous type artificial tooth replacement system that is intended for use in prosthetic dentistry to support restorations that resemble a tooth or group of teeth.

The provided text is a 510(k) summary for the OsseoLink Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

The document states:
"It has been shown in this 510(k) submission that the differences between the OsseoLink Dental Implant System and the predicate devices do not raise any questions regarding its safety and effectiveness. The OsseoLink system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices."

This indicates that the submission relies on demonstrating similarity to already approved devices rather than presenting a performance study with acceptance criteria for a new, distinct performance claim.

Therefore, I cannot provide the requested table and study details because the information is not present in the provided document. The 510(k) summary is for a dental implant system, which is a physical device, not an AI or algorithm-based device that would typically have the kind of performance metrics and study designs you've asked about (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance).

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