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The Klockner Vega TiBase for CEREC® abutments are titanium alloy abutments placed onto Klockner Vega Implants to provide support for customized prosthetic restorations. The Klockner Vega TiBase for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Klockner Vega TiBase for CEREC® abutments are to be designed and milled using Sirona CEREC Premium SW 4.2 software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Klockner Vega TiBase for CEREC® abutments are two-piece abutment (composed of the ti-base component and a ceramic mesostructure or coping) fabricated by using the Sirona Dental CAD/CAM System and are to be used with Klockner Vega Dental Implant Systems, with conical and hexagonal internal connection, platforms MV, NV, RV. The Klockner Vega TiBase for CEREC® are Ti-base abutments, made of titanium alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC® systems, and the base portion is available in three models to fit three Klockner® dental implant platforms.

The provided text is a 510(k) summary for the Klockner Vega TiBase for CEREC®. This document is primarily concerned with establishing substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a detailed performance study where "acceptance criteria" refers to the thresholds of performance for an AI/CADe device.

Therefore, the provided document does not contain the information requested for acceptance criteria and a study proving device meets those criteria, particularly in the context of an AI/CADe device. The Klockner Vega TiBase for CEREC® is a physical dental implant abutment, and its approval process focuses on bench testing (dimensional verification, dynamic fatigue, bending assays) and biocompatibility, as well as demonstrating equivalence to predicate devices, rather than statistical performance metrics like sensitivity, specificity, or reader improvement seen with AI/CADe devices.

The "bench testing" mentioned in the document is for mechanical properties and fit, not for statistical performance metrics against a ground truth as would be the case for an AI/CADe system.

Specifically, the document states:

• No clinical data are included in this submission. This immediately indicates that no study involving human subjects or real-world patient outcomes (which would be necessary for ground truth establishment and performance metrics) was conducted or provided.
• The discussions are centered on substantial equivalence to predicate devices based on indications for use, materials, design features, and manufacturing workflow, not on a new performance evaluation against defined acceptance criteria for an AI/CADe.
• Bench testing is mentioned for dimensional verification and dynamic fatigue/bending assays, which are engineering tests for a physical device, not performance studies for an AI algorithm.

In summary, none of the requested information regarding acceptance criteria, study design for AI/CADe performance, sample sizes for test/training sets, expert readers, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/CADe device is present in this document.

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