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CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

• CEREC Cercon 4D™ Abutment Block
• TiBase
• CAD/CAM system

The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.

CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to theBase (Titanium base) used with dental implant systems.

The provided document describes the substantial equivalence of the CEREC Cercon 4D™ Abutment Blocks and System, primarily focusing on non-clinical performance and material characteristics, rather than an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and study that proves the device meets those criteria from the perspective of a medical device (specifically, a dental abutment system), even without AI elements.

Here's the information based on the provided text, with Not Applicable (N/A) for fields that relate to AI/ML studies and are not covered in this document.

Acceptance Criteria and Device Performance for CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System

The device under review is primarily a dental abutment system, and its performance is evaluated based on material properties, mechanical strength, and software integration, not on diagnostic accuracy or AI assistance.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size for Test Set:
  • For Flexural Strength (Table 8.1): Not explicitly stated, but typically involves a certain number of samples to ensure statistical significance as per ISO 6872.
  • For Fatigue Testing (Table 8.2): "New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations." The exact number of samples per test condition is not specified in the document, but standardized tests like ISO 14801 would stipulate a minimum.
  • For Sterilization Validation, Biocompatibility, and Software Validation: Not explicitly specified in terms of sample count in this summary.
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "non-clinical tests" and "performance bench testing," indicating laboratory-based studies. The document does not mention if the data is retrospective or prospective, as this distinction is more relevant for clinical studies.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "ground truth" (or more accurately, established performance standards) for this device is based on mechanical properties and ISO standards, which are objective and do not require expert human interpretation in the way an AI diagnostic system would.

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

Not applicable, as no human expert interpretation or consensus review is involved in the performance testing of this device (e.g., physical strength, material composition).

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-assisted diagnostic device; therefore, MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm-based device. Its "system" aspect refers to the combination of the abutment block, TiBase, and CAD/CAM system for fabrication, not an AI algorithm. The performance described is of the physical components and the software's ability to constrain design parameters.

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

The "ground truth" for this device's performance is established by international consensus standards (e.g., ISO 6872, ISO 14801, ISO 10993, ISO 17665-1) for dental materials and implants, along with internal software integration requirements. These are objective, quantitative measures rather than subjective human interpretations or clinical outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device does not have a "training set" in the context of machine learning.

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

Not applicable. This device does not have a "training set" in the context of machine learning.

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The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
• Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
• Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
• Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
• The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors.

DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

MultiBase Abutments EV:
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

The proposed (A) OmniTaper EV Dental Implants are root form endosseous implants intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. The proposed (A) OmniTaper EV Dental Implants have the identical implant-abutment connection geometry as predicate (A) Astra Tech EV Implants (K120414). The proposed (A) OmniTaper EV Dental Implants are therefore compatible with the Astra Tech EV Abutments (K120414).

The proposed (B) DS Implant abutments with EV connection include the following abutments and accessories:

• TempBase EV, and its accessory component TempBase Cap
• Cover Screw EV
• Healing Abutment EV
• HealDesign EV
• TempAbutment EV
• TiDesign EV
• CastDesign EV
• MultiBase Abutment EV
• Abutment Screw EV

The proposed (B) DS Implants abutments with EV connection are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments that are:

• Compatible with the proposed (A) OmniTaper EV implants,
• Represent an additional abutment type (TempBase EV abutment and cap),
• Introduce additional abutment sizes (XS Extra Small and XL Extra Large) to the predicate (B) DS Implants abutments with EV Connection in sizes S (Small), M (Medium) and L (Large) (K213449).

The proposed (B) DS Implant abutments with EV connection have the identical implantabutment connection geometry as predicate (B) DS Implants abutments with EV connection (K213449) and the Astra Tech EV Abutments (K120414), and are therefore also compatible with predicate (A) Astra Tech EV Implants (K120414).

The proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV connection are single-use devices.

The proposed (A) OmniTaper EV implant with pre-mounted proposed (B) TempBase EV abutment, and the proposed (B) devices Cover Screw EV, Healing Abutment EV, HealDesign EV and (B) Multibase Abutment EV are provided sterile via Electronic-Beam (E-beam) irradiation.

The proposed (B) TiDesign EV, CastDesign EV, TempAbutment EV, TempBase Cap and Abutment Screw are provided non-sterile. Devices provided non-sterile are to be sterilized via steam sterilization, or as in the case of the TempBase Cap, cleaned/disinfected, by the end user prior to use per the Instructions for Use.

This response addresses the requested information based on the provided text, but it's important to note that the document describes a dental implant and abutment system, not an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable and will be marked as "Not Applicable (N/A)".

Device Name: OmniTaper EV Dental Implants and DS Implants abutments with EV connection

Device Type: Endosseous Dental Implants and Abutments

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) submission for dental implants and abutments, the "acceptance criteria" are demonstrated through substantial equivalence to predicate and reference devices, supported by non-clinical performance data (e.g., sterilization, biocompatibility, fatigue, MRI testing) and clinical literature review. There are no explicit performance metrics in the format of a typical diagnostic device's acceptance criteria, but rather a demonstration that the new devices are as safe and effective as existing legally marketed devices.

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

• Non-Clinical Test Set: The document describes various non-clinical tests (sterilization, biocompatibility, fatigue, MRI) but does not specify numerical sample sizes for these tests. It indicates that "worst-case" implant-abutment combinations were tested. The provenance of this data is internal to Dentsply Sirona or their contracted labs, as it states "Non-clinical testing data submitted, referenced, or relied upon..."
• Clinical Literature Review (Test Set): For the clinical relevance of the Ø3.0 implant, four peer-reviewed scientific publications were referenced. These studies presented 1 to 4 years of prospective clinical follow-up data on over 580 Xive S Plus D 3.0 implants. The country of origin for these publications is not specified, but they are peer-reviewed scientific literature.

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)

N/A. This device is a dental implant system, not a diagnostic AI device requiring expert-established ground truth for a test set. Clinical relevance was supported by published peer-reviewed literature.

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

N/A. This information is for AI performance evaluation. The device is a physical medical device.

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

N/A. This information is for AI performance evaluation. The device is a physical medical device.

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

N/A. This information is for AI performance evaluation. The device is a physical medical device.

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

• Non-Clinical Testing: Ground truth is established by standardized testing protocols and existing predicate device performance, ensuring properties like sterility, biocompatibility, and mechanical strength meet established engineering and safety standards.
• Clinical Literature Review: The clinical "ground truth" for the 3.0mm implant's effectiveness and safety (survival rates, stable marginal bone) is derived from outcomes data reported in multiple peer-reviewed scientific publications with prospective clinical follow-up.

8. The sample size for the training set

N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms. Its development and validation rely on engineering design, materials science, and non-clinical testing, followed by comparisons to predicate devices and review of existing clinical literature.

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

N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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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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