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IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: IPS e.max CAD mesostructure, Ti base and CAD/CAM software. The IPS e.max CAD mesostructure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. The compatible Implant systems, Ti bases and CAD/CAM systems are shown below: Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088, K062129, K060958), Biomet 3i Osseotite (K980549) CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above. For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. Titanium bases are a premanufactured prosthetic component directly connected to dedicated endosseous dental implants. The Titanium base is used for adhesion to mesostructures to restore function and esthetics in the oral cavity. IPS e.max CAD Abutment Solutions are lithium disilicate blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already include in the shipped block. Connection geometries fit select Titanium Bases marketed by Straumann, Nobel Biocare and Biomet 31 as identified in the Intended Use section. The mesostructure is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown as designed by the trained professional using the Sirona inLab and Cerec SW 4.2 (or higher) software.. The device serves as the esthetic mesostructure which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.

This document describes the IPS e.max® CAD Abutment Solutions, a dental device consisting of a lithium disilicate ceramic mesostructure cemented to a titanium base, designed for single cement-retained restorations in conjunction with endosseous dental implants.

1. Acceptance Criteria and Reported Device Performance:

The device's performance is assessed against physical properties outlined in ISO 6872:2008 for Dental Ceramics. The acceptance criteria and reported values are provided in the table below:

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The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:

• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abulment;
• Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques;
• Abutment Screws to permanently fix the abutments to the Implant.
  Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
  Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
  Core 3D abutments and are compatible for use with the following dental implants:
• Nobel Biocare Branemark System (K022562, K934825)
• Zimmer Tapered Screwvent (K013227, K061410, K072589)

The proposed devices are dental implant abutments intended to be placed into dental implants and to provide support for dental prosthetic restorations.
The system is composed of the following principal components:

• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
• Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques
• Abutment Screws: to fix abutments to the underlying dental implant.
  The final form of the device including superstructures to titanium bases and patientspecific designs for abutment blanks may be designed using CAD CAM techniques under Core3D design specifications and limitations using the following system:
• CAD/CAM Software: 3Shape Dental System including 3Shape Dental Designer
• Scanner: 3Shape D810 model
• Milling machine: SAUER HSC-20 DMG.
  Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
  The proposed Titanium Bases and Titanium Abutment Blanks are available with either an internal conical connection or external connection, depending on the underlying dental implant. The internal conical types are available in diameters of 3.4, 4.5, and 5.7mm for bases and in diameters of 3.5, 4.5 and 5.7mm for blanks. The external connection types are available in diameters of 3.5, 4.1 and 5.1mm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CORE 3D Abutment System for Digital Prosthetic Solutions:

Important Note: The provided document is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing entirely new safety and efficacy data through clinical trials. As such, the information you've requested regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies might not be explicitly present in the way it would be for a novel device. The document primarily highlights bench testing results proving compatibility and mechanical performance.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside reported device performance in the format of a clinical study. Instead, it states that bench testing was performed to determine conformance to performance specifications and requirements.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify the sample size used for the bench tests (e.g., number of abutments tested for mechanical properties).
• Data Provenance: The study was non-clinical bench testing. The document does not specify the country of origin for the data itself, but the submitter is based in Spain. It is retrospective in the sense that the testing was completed before the submission.

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

• Number of Experts: This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by engineering specifications and standards, not by human experts adjudicating clinical outcomes.
• Qualifications of Experts: Not applicable in the context of this type of non-clinical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for non-clinical bench testing. The results are typically compared directly against engineering specifications and industry standards.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
• Effect Size: Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.

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

• Standalone Performance Study: The document does not describe a standalone performance study in the way it might for an AI algorithm. However, standalone bench testing of the physical abutments and an evaluation of the CAD/CAM software (which operates without human intervention in determining design limits once programmed) effectively represent the "algorithm only" performance for the relevant aspects of this device. The software validation aimed to ensure the software's inherent design limitations correctly prevent non-compliant abutment milling.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical and dimensional aspects of the abutments and their mating, the ground truth was based on engineering specifications, industry standards, and perhaps predicate device performance data. For the CAD/CAM software, the ground truth for software validation was the Core3D design specifications and limitations.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided and is generally not applicable in a traditional sense for a physical medical device. The CAD/CAM software is likely developed based on engineering rules and algorithms, not "trained" on a data set in the machine learning sense.

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

• How Ground Truth for Training Set was Established: Not applicable in the context of this device. The "ground truth" for the software's design rules would have been established by engineering design principles, material properties, and regulatory requirements specific to dental abutments.

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The Synthes Radial Head Prosthesis System is intended for:

1. The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with
   a. Joint destruction and/or subluxation visible on x-ray
   b. Resistance to conservative treatment
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty.

The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.

This document is a 510(k) Summary for the Synthes Radial Head Prosthesis System. It is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way one might for a novel diagnostic or AI device.

Therefore, many of the specific questions regarding acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a medical implant device.

However, I can extract the relevant information regarding the performance testing and the approach to demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

Context: The Synthes Radial Head Prosthesis System is a medical implant (a modular radial head prosthesis) intended for the replacement of the radial head in specific orthopaedic conditions. The 510(k) submission aims to demonstrate that this new device is "substantially equivalent" to existing, legally marketed predicate devices. This means it has the same intended use, fundamental technological characteristics, and similar materials, and that performance testing shows it is as safe and effective as the predicates.

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

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of, for example, diagnostic accuracy (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices through various tests and analyses.

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: The document does not specify a "sample size" in terms of patients or anatomical specimens as one would for a clinical trial or diagnostic study. The "test set" here refers to the actual physical devices (or components thereof) that underwent in vitro performance testing and surface analysis. The number of such devices or samples tested is not disclosed in this summary.
• Data Provenance: The tests are described as "in vitro performance testing," "Macro Surface Analysis," "Scanning Electron Microscopy (SEM)," and "X-Ray Photoelectron Spectroscopy (XPS)." These are laboratory-based studies, not clinical studies involving patient data from specific countries or populations. The data provenance is controlled laboratory conditions.

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

• This question is not applicable to this type of device submission. The "ground truth" for a mechanical implant is its physical and mechanical properties, not expert-derived diagnostic labels. The performance is assessed through engineering and materials science testing, not clinical diagnosis by experts.

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

• This question is not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This submission focuses on the objective physical and mechanical properties of an implant.

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

• This question is not applicable. The device is a physical implant, not a diagnostic imaging or AI algorithm that would involve human readers or AI assistance.

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

• This question is not applicable. The device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is established by engineering and materials science standards and measurements. This includes:
  • Mechanical properties: The ability to withstand clinical loads.
  • Material properties: Chemical composition and physical and macro/micro surface characteristics.
  • Peer-reviewed literature: Used to demonstrate how these material and surface characteristics relate to physiological responses.

8. The sample size for the training set

• This question is not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical implant. The design and manufacturing processes are based on engineering principles and prior knowledge from predicate devices, rather than machine learning training.

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

• This question is not applicable, as there is no training set. The "ground truth" for the device's design and material selection would be established through established engineering principles, materials science, and conformity to relevant ASTM/ISO standards (though specific standards are not named in this summary).

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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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