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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components to the S.I.N. Dental Implant System components cleared in K200992, K193096, and K170398.

This submission includes dental implants Epikut CM with a Morse taper (CM) abutment interface and a double acid-etched endosseous surface, and Epikut Plus CM implants with an endosseous surface produced by double acid-etching followed by application of a hydroxyapatite coating (HA™Y). These implant endosseous surfaces are identical to those cleared in K200992.

This submission also includes dental implants Epikut HE with an external hexagon (HE) abutment interface and a double acid-etched endosseous surface, and Epikut Plus HE implants with an endosseous surface produced by double acid-etching followed by application of a hydroxyapatite coating (HA1000). These implant endosseous surfaces also are identical to those cleared in K200992.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K200992. K193096, and K170398. The Epikut Plus CM and Epikut Plus HE implants have the identical HA™ surface treatment cleared in K200992 and K193096.

The subject device dental implants are compatible with abutments and prosthetic components cleared previously in K200992. K193096. K170398. and K051859. Epikut HE and Epikut Plus HE dental implants are not for use with angled abutments.

The provided document (K211921 510(k) Summary for S.I.N. Dental Implant System) is a 510(k) premarket notification summary submitted to the FDA. It does not describe an AI medical device or a clinical study intended to prove its performance against acceptance criteria for such a device.

Instead, this document describes a dental implant system and its substantial equivalence to previously cleared predicate devices. The performance data presented are non-clinical bench tests (sterilization, bacterial endotoxin, shelf-life, biocompatibility, and coating characterization) to demonstrate the device's physical and biological properties.

Therefore, I cannot directly answer your prompt using the provided text, as the information regarding acceptance criteria, AI device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to the content of this document.

The document explicitly states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through non-clinical data and comparisons to predicate devices.

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