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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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The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. The system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The InCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the InCoris mesostructure. The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implants systems:

• Nobel Biocare Replace (K020646)
• Nobel Biocare Branemark (K022562)
• Friadent Xive (K013867)
• Biomet 3i Osseotite (K980549)
• Astra Tech Osseospeed (K091239)
• Zimmer Tapered Screw-Vent (K061410)
• Straumann SynOcta (K061176)

The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.
The system that features the processing of mesostructures comprises

• Titanium bases TiBase and Camlog
• inCoris ZI meso blocks
• Sirona Dental CAD/CAM Design and fabricating devices

Titanium bases are used as an implant prosthetic titanium base for adhesion to mesostructures to restore function and aesthetics in the oral cavity.
inCoris ZI meso blocks are used in manufacturing individually designed inCoris ZI meso mesostructures, which are glued to a fitting titanium base after milling and sintering.
Sirona Dental CAD/CAM design and fabricating devices feature the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. This component consists of the devices CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL and inLab MCXL.

The provided document is a 510(k) summary for a dental CAD/CAM system. It does not contain information about studies involving acceptance criteria in the traditional sense of AI/ML performance evaluation (e.g., sensitivity, specificity, accuracy, F1-score). Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, materials, design, and physical/performance characteristics.

Therefore, many of the requested categories for AI/ML study details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to the content presented in this 510(k) summary.

The closest equivalent to "acceptance criteria" and "device performance" in this context are the physical and chemical properties of the materials and the design/functional equivalence to established predicate devices.

Here's an attempt to extract relevant information given the nature of the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for overall device performance. Instead, it compares the new device's characteristics to those of predicate devices, arguing for "substantial equivalence." The performance characteristics listed are material properties and design features.

2. Sample size used for the test set and the data provenance

Not applicable. This document describes a medical device submission based on substantial equivalence to existing predicate devices, not a clinical or performance study with a test set of data. The "testing" referred to is nonclinical (fatigue analysis, reverse-engineering for design equivalence).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a test set is not relevant in this context. The document relies on engineering analysis and comparison against established standards and predicate device specifications.

4. Adjudication method

Not applicable. Adjudication methods are used in studies involving expert review, which is not described here.

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 CAD/CAM system for fabricating dental restorations, not an AI-assisted diagnostic or interpretive device involving human readers.

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

Not applicable. The CAD/CAM system involves an optical acquisition unit, software for design (human-in-the-loop), and milling machines. It's not a standalone algorithm in the AI/ML sense.

7. The type of ground truth used

For the material and physical properties, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5832-3:1996 for TiBase material, ISO 13356:1997 for inCoris ZI meso material) and direct comparison to predicate device specifications.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML algorithm requiring learning from data.

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

Not applicable.

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The HT III SA Fixture System 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 HT III SA Fixture System is for single and two stage surgical procedures. It is not for immediate load.

1. The HTⅢ SA Fixture System is dental implant made of titanium metal intended to The 111m of I hitalie byelom of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
2. HTⅢ SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has SA surface.
3. The HTII SA Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided text is a 510(k) summary for a dental implant system (HTIII SA Fixture System) seeking substantial equivalence to existing predicate devices. It does not describe any acceptance criteria or a study proving device performance against such criteria in the context of an AI/human comparative effectiveness study or a standalone algorithm performance study.

Instead, this document focuses on demonstrating substantial equivalence through comparisons of:

• Intended Use: The HTIII SA Fixture System is used in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations, and for single and two-stage surgical procedures (not for immediate load). This is directly compared to the predicate HGIII Fixture System, which has identical intended use, and generally aligns with the Straumann Standard Implant.
• Design and Technology: It highlights features like single threads, taper body type, self-tapping, submerged fixture, and internal hex connection, stating it's similar to the predicate HGIII Fixture System.
• Material: The device is made of Pure Titanium Grade 4 (ASTM F67-06), identical to both predicate devices.
• Surface Treatment: While the HTIII SA Fixture uses "SA" surface treatment, the predicate HGIII uses "RBM", and the Straumann Standard Implant uses "SLA". The document states the HTIII SA Fixture's surface treatment is "similar" to the Straumann Standard Implant.
• Biocompatibility and Safety: Biocompatibility tests were conducted according to ISO 10993 standards (ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, and ISO 10993-11), and surface treatment tests were performed. The results were found to be similar to previously cleared predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or AI study details because this document pertains to a medical device (dental implant) and its regulatory clearance process, not an AI or diagnostic imaging device involving performance metrics like sensitivity, specificity, or reader studies.

The "study" referenced in this document is a series of non-clinical tests (biocompatibility and surface treatment) demonstrating the device's safety and performance characteristics are similar to predicate devices, thereby supporting its substantial equivalence for regulatory clearance.

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