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The Replace® One Piece Implant is a threaded one-piece implant with an integrated abutment, designed for single-stage surgical procedure and cemented restorations. The Replace® One Piece Implant is intended for immediate load on single tooth and multiple tooth applications in good quality bone, to restore chewing function.

The Replace One Piece Implant is a one-piece, threaded root-form implant based on the Nobel Biocare Replace implant design. The new configuration of the implant is designed with an integrated abutment that will eliminate the step of attaching the abutment. This combination of design characteristics also includes acid etching of the transmucosal/transgingival neck to encourage connective tissue attachment for esthetics purposes. The device is manufactured of CP4 Titanium and is offered in TiUnite and HA Coating. This device will be offered in diameters of 3.5. 4.3. and 5.0mm, each in lengths of 10, 13, and 16mm. This implant is designed for immediate load applications in partially edentulous patients.

This device is an implant, and as such, the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The document is a 510(k) summary for a dental implant (Replace® One Piece Implant) seeking market clearance, which typically involves demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than performance metrics related to diagnostic accuracy or AI algorithm performance.

Therefore, I cannot fulfill your request for the tables and information regarding acceptance criteria and performance studies. The document describes a physical medical device, not a software or AI-based diagnostic tool.

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