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The Titanium Base for CEREC is a titanium component that is placed over Neodent Implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Titanium Base for CEREC consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.

The Titanium Base for CEREC abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications and are provided in a 4.65 mm prosthetic platform diameter and seven gingival heights (0.8, 1.5, 2.5, 3.5, 4.5, 5.5 and 6.5 mm), all having a 4.7 mm prosthetic height. They also feature:

• cylindrical shape
• hexagonal indexing at the apical end of the Morse taper connection
• indexing guide in the cementable portion for coping fitting

The CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.

The Titanium Base for CEREC is provided sterile by Ethylene Oxide and steam sterilization is recommended after the cementation of the customized superstructure on the Titanium Base for CEREC.

The Titanium Base for CEREC is compatible with the following devices:

Dental implants
All Neodent dental implants having Morse taper implant-to-abutment interface (CM line) cleared under K101945, K123022, K133592, K150182 and K150199.

Raw material blanks

• -InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664;
• -IPS e.max CAD Abutments Solutions (LiSi₂) by Ivoclar Vivadent AG, L size blanks, cleared under K132209.

Software
Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.

Instruments

• -Neodent screwdrivers (class I - exempt devices)
• Sirona scanbodies (class I exempt devices)

The provided text is a 510(k) premarket notification for the "Neodent Implant System - Titanium Bases For Cerec" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving device performance through a standalone study with a test set, expert ground truth, or MRMC studies.

Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), and details on training set ground truth cannot be directly extracted from this document, as it outlines a comparison and testing against existing standards and predicate devices.

However, I can extract information about the types of performance data used to support substantial equivalence, which acts as a proxy for meeting certain "acceptance criteria" related to safety and effectiveness by demonstrating similarity to already cleared devices.

Here's a breakdown of what can be inferred:

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

The document does not present explicit acceptance criteria with numerical targets in the traditional sense, as it relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards. The "reported device performance" is framed as meeting these standards or being comparable to predicate devices.

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" for performance evaluation in the typical sense.

  • Biocompatibility: No new testing was performed; reliance on prior clearance of the material.
  • Mechanical Testing: Not specified for this submission, but it refers to tests presented in K153624 (a reference predicate). For fatigue testing per ISO 14801, a specific number of samples (typically 5, 8, or 10, depending on the method) would be tested. The number isn't provided here.
  • Software Verification & Validation: The document states the "Titanium Base for CEREC was verified and validated with respect to its functionality and design using the Sirona validated workflow." This implies testing against the workflow, but specific sample sizes (e.g., number of test cases, scenarios) are not provided.
  • Sterilization Validation: Sterilization validation studies typically involve a defined number of biological indicators (BIs) or process challenge devices (PCDs) per run, over multiple runs. Specific numbers are not provided, only the standards used (ISO 11135, ISO 17665-1).

• Data Provenance: Not explicitly stated. Given Neodent's location in Brazil (JJGC Indústria e Comércio de Materiais Dentários SA, Curtiba, Parana, BRAZIL), it's reasonable to infer that any original data generation would have been conducted in either Brazil or relevant testing laboratories supporting their operations, or by the manufacturers of the predicate devices. The study type (retrospective/prospective) is not detailed.

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)

Not applicable. This device is a dental implant component, not an AI or diagnostic imaging device that requires expert adjudication for ground truth. Its performance is evaluated through material properties, mechanical testing, and software validation.

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

Not applicable, as this is not an AI or diagnostic imaging device for which such adjudication methods would be relevant.

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.

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

Not applicable. This is a physical medical device. Software verification was performed, but not as a "standalone algorithm" in the typical sense of AI performance evaluation.

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

The "ground truth" for this device's performance is established by:

• Material Specifications: Adherence to ASTM F136 for titanium alloy.
• Mechanical Performance: Demonstrating strength and fatigue resistance according to ISO 14801.
• Sterilization Efficacy: Achieving performance per ISO 11135 and ISO 17665-1 standards.
• Software Functionality: Verification and validation against predefined functional requirements within the Sirona validated workflow.
• Predicate Device Equivalence: The ultimate "ground truth" for this 510(k) is that the device is as safe and effective as its legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm trained on data sets. The "training set" concept is not relevant here.

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

Not applicable, for the same reason as point 8.

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