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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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The Biogenesis Implant System - Aticon is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Biogenesis Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

The Biogenesis™ Implant System replaces the root of a missing tooth and is made from surgical grade titanium alloys. The Biogenesis™ Implant System is comprised of two components, implant, which is the portion that goes into the jaw bone, and the abutment, which fits into the implant and provides a solid base for a crown or a denture.

The provided document describes a 510(k) premarket notification for the "Biogenesis™ Implant System - Aticon," a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with acceptance criteria for device performance as would be seen for novel devices.

Therefore, many of the requested elements for a study proving acceptance criteria (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and specific ground truth establishment) are not applicable to this type of regulatory submission. The "study" here is primarily a non-clinical comparison and validation against established standards and predicate devices.

Here's a breakdown of the available information in relation to your request:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not reported as quantitative performance metrics against specific benchmarks for clinical outcomes as one might expect for a new performance claim. Instead, the acceptance criteria are implicitly that the device must be "substantially equivalent" to predicate devices in terms of materials, design, function, and intended use, and must pass non-clinical safety tests.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (material analysis, sterility, biocompatibility) rather than a clinical "test set" of patients.
• Data Provenance: The non-clinical testing was conducted to validate the device's safety. The manufacturer, Biogenesis Co., Ltd., is located in the Republic of Korea. Therefore, the non-clinical test data likely originated from Korea or an accredited lab engaged by the manufacturer. The data would be considered prospective in the sense that these tests were performed specifically for this submission.

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 was no clinical "test set" that required ground truth establishment by experts for performance evaluation in the context of this 510(k). The "ground truth" for the non-clinical tests is established by the relevant ISO standards and analytical methods used (e.g., ISO 10993-5 for cytotoxicity).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. There was no clinical "test set" requiring adjudication.

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 is a dental implant system, not an AI-powered diagnostic device, and no MRMC studies were performed or are relevant to this 510(k) submission.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical tests (e.g., material analysis, cytotoxicity, sterilization), the "ground truth" is defined by the validated and recognized international standards (e.g., ISO 10993-5) and analytical methods used in laboratories to assess material properties, biocompatibility, and sterilization effectiveness. "Substantial equivalence" to predicate devices, which are already deemed safe and effective, also serves as a form of ground truth for regulatory acceptance.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set."

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