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The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.

The Genesis Implant System includes implants, and associated surgical, restorative and dental laboratory components. Genesis implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement tooth root, which provides a stable foundation for restorations. Genesis implants are manufactured from Grade 4 titanium, have a tapered or straight cylindrical design with an internal indexing connection, and are available in various platform diameters and lengths. The implants have a macro-, micro- and nano-topography and are treated with the BioSpark process, which results in a hydrophilic surface enriched with calcium and phosphorous ions. The implant collar is micro-roughened and treated with the AnaTite" process, which results in a pink color for enhanced esthetics. The majority of Genesis abutments are manufactured from Grade 5 titanium and are treated with the AnaTite process. Other Genesis abutments are made from Grade 5 titanium/plastic or gold alloy/plastic. Abutments intended for fixed restorations utilize a Grade 5 titanium screw for attachment to the implant. Genesis abutments and associated restorative components are manufactured in a variety of sizes and configurations to be compatible with the implant platforms.

The provided text is a 510(k) summary for the Genesis Implant System, a dental device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. This type of submission generally doesn't include the same kind of detailed acceptance criteria and clinical study results that an AI/software as a medical device (SaMD) would. Therefore, much of the requested information regarding AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance is not applicable or cannot be extracted from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table as would be expected for a SaMD that relies on specific performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices through a combination of material properties, design characteristics, and non-clinical testing confirming those characteristics are maintained or improved.

The device performance is reported in qualitative terms, demonstrating properties consistent with or superior to predicate devices.

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

This document describes non-clinical testing (bench studies, in vitro studies, animal studies). There is no "test set" in the context of human data or AI model evaluation.

• Fatigue Testing: Conducted in accordance with ISO 14801 and FDA Special Controls Guidance. The number of implants/abutments tested is not specified.
• Insertion Torque Bench Study: Used "simulated bone material." The sample size is not specified.
• AnaTite In Vivo Study (Coloration): "An in vivo study has shown..." No details on sample size or species.
• BioSpark Animal Study (Osseointegration): "significant bone-to-implant-contact (BIC) in the cortical bone of sheep at 4 weeks." Sample size not specified.
• BioSpark In Vitro Studies: These involved "cp-Ti disks" (commercially pure titanium disks). Sample sizes for these experiments are not specified.

Data Provenance:

• Bench studies (fatigue, insertion torque)
• In vitro studies (cellular metabolic activity, osteoblast proliferation, fibronectin absorption, adhesion, proliferation, differentiation)
• Animal studies (sheep for BIC, unspecified animal for AnaTite coloration)
• Published literature (for mineralization potential)

All these are non-clinical, controlled experiments. No human data (retrospective or prospective) is mentioned for the performance evaluation of the device itself.

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

Not applicable. This is not an AI/SaMD submission evaluating human data against expert ground truth. The "ground truth" for the non-clinical tests is based on objective measurements and established scientific methods (e.g., ISO standards, microscopy, spectroscopy, biological assays, bone-to-implant contact measurements).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as there is no human-annotated test set requiring adjudication in this context.

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 not an AI/SaMD. There are no "human readers" or "AI assistance" relevant to an MRMC study described in this submission.

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

Not applicable. This device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluations relies on:

• Physical measurements and material science: e.g., chemical composition (energy dispersive spectroscopy, sputter mass spectroscopy), surface topography (scanning electron microscopy), wettability (contact angle testing), mechanical strength (fatigue testing per ISO 14801).
• Biological assays in vitro: measuring cellular metabolic activity, osteoblast proliferation, fibronectin absorption, adhesion, and differentiation.
• Histomorphometry in animal models: bone-to-implant contact (BIC) in sheep.
• Visual assessment (in vivo): comparing pink coloration to natural gingival tissue.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/SaMD. There is no concept of a "training set" for physical device testing. The "learning" for the device design would come from long-standing scientific and engineering principles in dental implantology, feedback from predicate devices, and internal R&D.

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

Not applicable. No training set in the AI sense. The design and material choices are informed by existing scientific knowledge, performance of predicate devices, and internal research and development validated by the non-clinical tests described.

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