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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 implant 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 PrimeTaper EV Ø3.0 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) PrimeTaper EV Dental Implant Ø3.0 is a root form endosseous implant which is intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. It represents an additional extra small implant diameter implant) to reference device PrimeTaper EV Dental Implants (K210610).

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 has the identical implant-abutment connection geometry as the predicate (A) Astra Tech EV Implant (K120414), and is therefore compatible with the reference device Astra Tech EV Abutments (K120414) with 3.0 mm diameter of the Astra Tech Implant System EV (K120414).

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

• TiDesign EV (XS) ●
• MultiBase Abutment EV (XS) ●
• . TempAbutment EV (XS)
• Healing Abutment EV (XS) ●
• HealDesign EV (XS) ●
• Cover Screw EV (XS)
• Abutment Screw EV (XS) ●

The proposed (B) DS Implants abutments with EV connection XS 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 compatible with the proposed (A) PrimeTaper EV Dental Implant Ø3.0 and represent an additional extra small abutment-implant diameter (XS, 3 mm diameter) to the Predicate (B) DS Implants abutments with EV Connection in sizes S (small), M (medium) and L (large) (K213449).

The proposed (B) abutments have the identical implant-abutment connection geometry as the reference device Astra Tech EV Abutments (K120414) and are therefore compatible with the predicate (A) Astra Tech EV Implants (K120414) with 3.0 mm diameter.

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 and proposed (B) DS Implants abutments with EV connection XS are single-use devices and are provided sterile by electron-beam irradiation except for TiDesign EV (XS). TempAbutment EV (XS) and Abutment Screw (XS), which are provided non-sterile. Devices provided as non-sterilized by the end user via steam sterilization.

The document provided is a 510(k) summary for Dentsply Sirona's PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection (XS). It describes the devices, their intended use, and substantial equivalence to predicate and reference devices based on non-clinical performance data and published literature.

Here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner with specific thresholds. Instead, it relies on demonstrating that the proposed devices (PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection XS) are substantially equivalent to legally marketed predicate devices. The performance is assessed by confirming that the proposed devices satisfactorily meet the requirements of non-clinical bench testing and aligning with published clinical data on similar devices.

However, based on the non-clinical testing performed, we can infer performance criteria against established standards:

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 Testing (Bench Tests): The document refers to "worst-case implant-abutment combination" for fatigue testing but does not specify the exact number of samples tested for each non-clinical performance test (e.g., fatigue, biocompatibility, sterilization validation, MRI). It is implied that sufficient samples were tested to meet the requirements of the respective ISO and ASTM standards.
• Clinical Literature:
  • Sample Size: 200 narrow diameter implants (OsseoSpeed 3.0 mm, Astra Tech Implant System (K080396)) were evaluated. These implants were placed in "over 160 patients."
  • Data Provenance: The data is from "six peer-reviewed scientific publications" presenting "1 to 5 years of clinical follow-up data from four (4) different clinical trials." The country of origin is not specified but it relates to published peer-reviewed scientific literature. The studies were prospectively followed up.

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)

This section is not applicable to this submission. The "ground truth" in this context is established through compliance with recognized international standards (ISO, ASTM) for non-clinical testing and clinical outcomes reported in peer-reviewed literature, rather than expert adjudication of a test set in the way one might see for an AI algorithm.

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

Not applicable. This is not an AI/imaging device where expert adjudication for ground truth establishment is typically performed.

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 submission is for dental implants and abutments, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is not an AI/algorithm-based device.

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

• Non-clinical Testing: The "ground truth" for non-clinical performance (sterilization, biocompatibility, fatigue, MRI safety, pyrogenicity, packaging) is defined by established international standards (ISO, ASTM) and FDA guidance documents. The device's performance is measured against these technical standards.
• Clinical Performance (via literature): The "ground truth" is based on outcomes data (survival rates, marginal bone maintenance) reported in peer-reviewed clinical literature.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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