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The XiVE® 3.0 Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

The XiVE® 3.0 Dental Implant System consists of subgingival threaded dental implants with 11 - 15mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® 3.0 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single tooth and splinted tooth restorations in the anterior regions of the mouth.

The provided text does not contain detailed information about specific acceptance criteria or a study proving that the dental implant device meets those criteria in the form usually associated with AI/ML-driven device evaluations (e.g., sensitivity, specificity, AUC, human reader improvement).

Instead, this document is a 510(k) summary for a dental implant system, which is a physical device, and the evaluation focuses on its substantial equivalence to a predicate device. The "performance evaluations" mentioned are likely related to mechanical strength, biocompatibility, and similar engineering and biological assessments, rather than diagnostic AI performance metrics.

Here's an analysis based on the provided text, highlighting what is and is not present concerning your request:

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

This information is not explicitly provided in the format requested for an AI/ML device. The document states:

• "Performance evaluations of the XiVE® 3.0 dental implant system show that the device performs as intended."
• "Comparisons of the XiVE® 3.0 dental implants to the predicate devices show that the device is substantially equivalent."

These are general statements about the device meeting expectations, but specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) and their corresponding performance values are not detailed in this summary. The 510(k) process for this type of device typically relies on demonstrating equivalence in design, materials, and mechanical properties to a previously cleared predicate device.

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

This information is not available in the provided text. For a physical device like a dental implant, "test set" might refer to the number of implants subjected to mechanical testing or animal/human studies for biocompatibility and integration. However, the details of such tests (sample size, nature of the data, origin) are not included in this summary.

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

This is not applicable and not mentioned. For a dental implant, "ground truth" would relate to its physical properties, biocompatibility, and osseointegration, which are established through engineering tests, material science, and clinical observations, not expert consensus on image interpretation.

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

This is not applicable and not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in AI/ML performance studies where multiple human readers independently evaluate cases to establish a robust ground truth for diagnostic tasks.

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 is not applicable and not mentioned. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to AI-powered diagnostic devices, not purely mechanical dental implants.

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

This is not applicable and not mentioned, for the same reasons as above. This is a physical medical device, not an algorithm.

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

As discussed, the concept of "ground truth" in the context of an AI device's diagnostic performance is not directly applicable here. For a dental implant, performance is assessed against established engineering standards, material specifications, and clinical outcomes related to successful osseointegration and long-term stability. The text indicates "complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in a Device Master File," which would be part of the technical documentation establishing its characteristics.

8. The sample size for the training set:

This is not applicable and not mentioned. There is no AI/ML algorithm being "trained" in this context.

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

This is not applicable and not mentioned.

In summary, the provided document describes a 510(k) submission for a dental implant system, a physical device, and its clearance is based on demonstrating substantial equivalence to an existing predicate device. The information requested regarding AI/ML device performance metrics (acceptance criteria for diagnostic performance, test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) is not present in this document because it is not an AI/ML device submission.

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The XiVE 3.0 Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

The XiVE 3.0 Dental Implant System consists of subgingival threaded dental implants with a 3.25mm diameter and lengths of 11 -- 15mm . The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement in the anterior regions of the mouth.

The provided text describes a 510(k) premarket notification for the FRIADENT GmbH XiVE® 3.0 Dental Implant System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as would be found for a novel AI/software medical device.

Therefore, many of the specific details requested regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods are not explicitly present in the provided text, as this type of information is typically not included in a 510(k) summary for a dental implant demonstrating substantial equivalence.

Here's an analysis based on the available information:

Description of Acceptance Criteria and Proving Device Meets Criteria

The document states: "Performance evaluations of the XiVE 3.0 dental implant system show that the device performs as intended for the anterior region of the mouth. Comparison of the XiVE 3.0 dental implant system to the predicate device show that the device is substantially equivalent."

This suggests that the "acceptance criteria" primarily revolved around demonstrating substantial equivalence to the predicate device in terms of design, materials, coatings, mechanical strength, prosthetic options, and intended use, as well as satisfactory performance for its intended use. The specific quantitative criteria for "performance as intended" are not elaborated.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The document mentions "performance evaluations" and mechanical testing (compressive, static strength, finite element analysis) but does not provide numbers of devices tested or specific clinical data from a "test set."
• Data provenance: Not explicitly stated. The tests conducted (compressive, static strength, finite element analysis) are typically laboratory-based engineering tests rather than clinical trials with patient data.

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

• Not applicable as this is not a study requiring expert-established ground truth in the context of diagnostic interpretation (e.g., radiology). The "ground truth" for a dental implant would be its physical properties and mechanical performance.

4. Adjudication method for the test set

• Not applicable. This is not a study involving human interpretation or subjective assessment that would require 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

• Not applicable. This is a dental implant, not an AI/software device that assists human readers.

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

• Not applicable. This is a dental implant, not an algorithm.

7. The type of ground truth used

• The ground truth for a dental implant's performance would be derived from engineering specifications, material science standards, and mechanical testing results (e.g., strength, fatigue life, material composition). The document mentions "compressive and static strength and finite element analysis," which are methods to establish this type of ground truth.

8. The sample size for the training set

• Not applicable. This is a dental implant, not a machine learning model, so there is no "training set."

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

• Not applicable.

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