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iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The iSy Implant System is an endosseous dental implant system designed for ease of use. Each product package contains the components needed for implant placement, impression taking, gingival contouring, and temporization. Components available with the iSy Implant System include the implant base, cover cap, multifunctional cap, gingiva former, universal abutment and Titanium base CAD/CAM. The implants are provided in three diameters (3.8, 4.4 and 5.0 mm) and three lengths (9, 11, and 13 mm). The implant/abutment interface is identical for all sizes and, therefore, only one abutment connection is necessary. The implant base is a mount, supplied with the implant, that also can be used for temporary restoration. Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°. The cover cap, multifunctional cap and gingiva former are temporary abutments used during healing. The universal abutment and titanium base CAD/CAM are abutments used for final restoration. The iSy implants are made of unalloyed titanium, iSy implant base, universal abutment and Titanium base CAD/CAM are made of titanium alloy, and iSy cover cap, multifunctional cap and gingiva former are made of polyetheretherketone.

The provided document is a 510(k) premarket notification for the Altatec GmbH iSy® Implant System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain information related to acceptance criteria, device performance, ground truth establishment, sample sizes for test/training sets, adjudication methods, or MRMC studies for an AI/ML powered medical device. The device described is an endosseous dental implant system, which is a physical medical device, not a software or AI/ML product.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document refers only to non-clinical testing data such as engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801. It explicitly states: "Clinical data were not submitted in this premarket notification."

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