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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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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for singleunit 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.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N. - validated milling center for manufacture.

The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. The K170392 submission included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. Components cleared in K 170392 included the Unitite line of dental implants that have a threaded endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA""). All other dental implants cleared in K170392 had a threaded endosseous surface that was acid-etched only (no HA100).

This submission adds the following components to the S.I.N. Dental Implant System: the identical HA1000 coating to the Strong SW CM (Morse taper) implant line cleared in K170392; the identical HA™® coating to the Strong SW HE (external hexagon) implant line cleared in K170398; the identical HA-"00 coating to the Strong SW HI (internal hexagon) implant line cleared in K170398: a new implant line, Tryon Conic HE, with an external hexagon abutment interface; a series of conventional (not CAD-CAM) prosthetic components that are compatible with implants from the S.I.N. Dental Implant System; and a series of CAD-CAM prosthetic components for fabrication of patient-specific restorations that are compatible with implants from the S.I.N. Dental Implant System.

This document is a 510(k) Premarket Notification from the FDA regarding the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies is not available and cannot be extracted from the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document outlines design and material specifications for various components and compares them to predicate devices, but it does not list specific numerical acceptance criteria or performance metrics for the device itself. The "PERFORMANCE DATA" section states "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: sterilization validation... bacterial endotoxin testing and shelf life testing... biocompatibility data... and biocompatibility testing for the ISO 13356 zirconia material... No clinical data were included in this submission." This indicates that performance data generally refers to compliance with standards (e.g., ISO, ASTM) and physical/biological characteristics, not clinical performance metrics against acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No clinical or performance study with a "test set" and corresponding sample size is described. The non-clinical data mentioned are related to validation and biocompatibility, not a clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. There is no mention of a test set requiring expert ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a dental implant system, not an AI software or system that involves human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a dental implant system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical ground truth is established for performance evaluations in this submission, as it relies on substantial equivalence to predicate devices based on design and material similarities, and compliance with recognized standards.

8. The sample size for the training set: Not applicable. This is not an AI/algorithm submission requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm submission requiring a training set.

In summary, the provided text describes a 510(k) submission for a dental implant system, which focuses on demonstrating substantial equivalence through comparisons of design, materials, and intended use with already cleared devices and adherence to relevant non-clinical standards (sterilization, biocompatibility, etc.). It explicitly states that "No clinical data were included in this submission." Therefore, the detailed information requested about acceptance criteria, study design, and performance metrics in the context of clinical or comparative effectiveness studies is not present.

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