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The Biogenesis Implant System –Kisses is in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Biogenesis Implant System - Kisses is for single and two stage surgical procedures. It is for delayed loading.

The Biogenesis 110 Implant System - Kisses is a dental implant system made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches. This product is a substructure of a dental implant system to replace a single tooth, partial tooth and the lost root of edentulous patients. It consists of the hex part to be coupled to the superstructure, the single thread part to be fixed to the bone, and the cutting edge part with the self-tapping function.

The Biogenesis™ Implant System offers bone level implants in the size range of 3.8 – 5.5 mm diameter with 7 – 14.5mm length.

The Biogenesis TM Implant System also offers the following components.

• · Duplex Abutment
• Duplex Milling Abutment
• Simplex Abutment
• Temporary Abutment
• · Solid Screw Abutment
• · Ball Abutment
• Ball Cap

The implants are intended for use with straight implant only straight implants are included in the submission.

The provided text is a 510(k) summary for the Biogenesis™ Implant System - Kisses, a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through the kind of studies you describe.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be fully extracted from this document. This kind of detailed study information is typically found in the full submission, not in the public 510(k) summary.

However, I can provide the limited information available regarding non-clinical testing and general acceptance of performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "the test results met the pre-set criteria" for various performance tests. However, it does not explicitly list quantified acceptance criteria or specific numerical reported device performance values. It only confirms conformance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on:

• Specific sample sizes used for the non-clinical tests (e.g., sterilization, shelf life, biocompatibility).
• Data provenance (e.g., country of origin, retrospective or prospective) for any test sets. Non-clinical studies like these are typically lab-based and not derived from clinical patient data in the same way clinical trials are.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the non-clinical bench testing described. These tests involve laboratory measurements and standards conformance, not expert assessment of clinical data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to the non-clinical bench testing described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through comparison of technical characteristics and non-clinical bench testing to predicate devices, not on evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm-only) performance study was not mentioned. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference points were established by recognized international and national standards:

• ISO 17665-1/2 and ANSI/AANI ST79 for sterilization validation.
• ASTM F1980 for shelf life testing.
• ISO 10993-1 for biocompatibility testing.
• FDA Guidance Document for Endosseous Dental Implants and Abutments for overall conformance.

These standards define methods and acceptable limits for the performance characteristics being evaluated.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a physical medical device (dental implant), not an AI/ML algorithm that would typically require a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable, as there is no mention of a training set for an AI/ML algorithm.

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