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The Biodenta Customized Abutment - Titanium is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment - Titanium is compatible with the following dental implant systems:

Biodenta Customized Abutment - Titanium is a one-piece custom abutment made of titanium. It utilizes an Abutment Screw for abutment retention.

The upper portion is designed by a dental technician using CAD software and manufactured at Biodenta milling centers. The final cement retained restoration is constructed in the lab according to the dentist's specifications.

The Abutment and the Abutment Screw are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biodenta Customized Abutment - Titanium:

Based on the provided document, the device in question is a dental abutment, and its acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, primarily through mechanical and biocompatibility testing, rather than clinical performance metrics typically associated with AI-powered diagnostic tools.

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets for performance and reported device performance in the typical sense of a diagnostic or predictive device (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices, and the "performance" is primarily shown through non-clinical testing results.

The critical acceptance criteria for this type of device revolve around:

• Mechanical Strength/Integrity: The device must demonstrate sufficient mechanical strength for its intended clinical application, particularly under fatigue loading.
• Biocompatibility: The materials used must be biocompatible.
• Fit and Compatibility: The customized abutment must fit well with the original manufacturer's implants as intended.
• Sterilization Effectiveness: The recommended sterilization method must be validated.

Here's a summary of the implicit acceptance criteria and the reported device performance:

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

The document does not specify a "test set" in the context of clinical trials with human subjects. The testing described is non-clinical:

• Fatigue Testing: "The worst-case scenario for the Biodenta Customized Abutment - Titanium and implant was tested." The sample size for fatigue testing (number of abutments/implants tested) is not specified.
• Engineering and Compatibility Analysis: This involved measuring "original implant manufacturer's implant analogs, abutments, and abutment screws." The number of samples measured is not specified.
• Sterilization Validation: Conducted according to ISO 17665-1:2006. Sample sizes for sterilization validation are not detailed.

The data provenance is from non-clinical laboratory testing conducted by Biodenta Swiss AG. The country of origin for the testing would presumably be Switzerland, where Biodenta Swiss AG is located. The nature of these tests is not "retrospective" or "prospective" as those terms apply to clinical studies; these are laboratory-based, controlled experiments.

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 question is not applicable to the provided information. The device is a dental abutment, not a diagnostic imaging device or an AI algorithm requiring expert ground truth for a test set. The validation relies on engineering and material science principles, against established FDA guidance documents and international standards, rather than expert interpretation of clinical data in the manner of a diagnostic study.

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

This question is not applicable for the same reason as point 3. There is no "test set" of clinical cases requiring expert adjudication.

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 dental abutment, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this type of device.

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 dental abutment, not an algorithm.

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

The "ground truth" for this device type is established by:

• Industry Standards and Regulatory Guidance: Adherence to FDA Guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments") and international standards (e.g., ISO 17665-1:2006 for sterilization).
• Material Properties: Established biocompatibility and mechanical properties of Ti-6AI-4V ELI as per ISO 3852-3 and ASTM F136.
• Engineering Measurements and Analysis: Ensuring precise fit and compatibility with specified implant systems based on direct measurements and engineering analysis.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of an AI algorithm for this device. The design and manufacturing process for the customized abutment involves CAD software and milling centers, but this is an engineering process, not an AI training process.

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

This question is not applicable as there is no training set for an AI algorithm. The design and manufacturing parameters for the abutment would be based on dental engineering principles, anatomical considerations, and compatibility specifications for various implant systems.

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