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The XiVE® TG Dental Implant System is indicated for singlestage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular spinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants.

In the edentulous maxilla, a minimu of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together.

In the edentulous mandible, a minimum of four transgingival implants (> 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® TG Dental Implant System consists of transgingival threaded dental implants in 3.4 -4.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® TG Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for splinted crowns, bridges and complete dentures. In the edentulous mandible, the XiVE® TG transgingival dental implants are indicated for immediate loading procedures using the standard protocol.

The provided document is a 510(k) summary for the XiVE® TG Dental Implant System. It presents information regarding substantial equivalence to a predicate device, rather than detailed studies demonstrating performance against pre-defined acceptance criteria for a new device.

Therefore, the requested information, specifically acceptance criteria, device performance from a new study, sample sizes for test sets, ground truth establishment details, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (K024004) due to a change in the surface morphology of the implant.

Here's an explanation of why the requested items are not present:

1. Table of acceptance criteria and reported device performance: This document asserts substantial equivalence, stating that "Performance evaluations of the XiVE® TG dental implant system show that the device performs as intended." However, it does not provide specific acceptance criteria or quantitative performance data from these evaluations. The focus is on demonstrating that the new device is functionally identical to the predicate.

2. Sample size for test set and data provenance: No specific test set or study with corresponding sample size and data provenance information is described. The clearance relies on equivalence to a previously cleared device.

3. Number of experts used to establish ground truth and their qualifications: Not applicable, as there's no diagnostic or interpretative test set described needing expert ground truth.

4. Adjudication method: Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device is a dental implant, not an imaging or diagnostic AI tool that would typically involve human readers.

6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device (dental implant), not an AI algorithm.

7. Type of ground truth used: Not applicable, as no ground truth for a diagnostic or interpretative task is required.

8. Sample size for the training set: Not applicable, as there is no mention of a machine learning or AI model being trained.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance (without specific data):

• "Performance evaluations of the XiVE® TG dental implant system show that the device performs as intended." (Section 17.9, "CONCLUSIONS")
• The device is "substantially equivalent to the current XiVE® TG Dental Implant Systems in terms of design, materials, mechanical strength, prosthetic and laboratory options and intended use." (Section 17.5, "SUBSTANTIAL EQUIVALENCE")
• "The only difference is the change in the surface morphology of the dental implant to the FRIADENT Surface M2.1." (Section 17.7, "TECHNOLOGICAL CHARACTERISTICS")
• "The complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in a Device Master File." (Section 17.9, "CONCLUSIONS") This implies that the properties of the new surface were characterized, but the details are not in this summary.

In essence, this 510(k) summary is a declaration of substantial equivalence based on the device's similarity to an already cleared product, with the only change being a surface modification that is presumed not to raise new questions of safety or effectiveness. It does not provide the detailed study results that would typically be found for a novel device or a device making new performance claims.

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