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The FRIALIT-2® Dental Implant System is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.

The FRIALIT-2® 3.4mm Dental Implant is an addition to the FRIALIT-2® Dental Implant System currently in commercial distribution. The FRIALIT-2® 3.4mm dental implant is available as a stepped cylinder coated with either FRIOS® TPS (titanium plasma sprayed) coating or FRIOS® HA (hydroxylapatite) coating, and a stepped screw-type implant line coated with the FRIOS® Deep Profile Surface. Surgical, prosthetic and laboratory components to facilitate the placement and restoration of the 3.4mm implant have also been designed.

This document describes the FRIALIT-2® 3.4mm Dental Implant and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and device performance. Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert qualifications, ground truth, or MRMC studies.

The document focuses on demonstrating that the new 3.4mm implant system is substantially equivalent to existing FRIALIT-2® systems and the Nobel BioCare Branemark 3.75mm dental implant based on design, materials, coatings, prosthetic options, functionality, mechanical strength, and intended use.

Here's what can be extracted:

Acceptance Criteria and Device Performance:

No specific "acceptance criteria" with numerical targets or "reported device performance" metrics are provided in the traditional sense of a clinical or analytical study. Instead, the "acceptance criteria" are implied by the substantial equivalence argument, meaning the device must be comparable to the predicate devices in the following aspects:

Missing Information:

The following information is not present in the provided text, as the document is a 510(k) summary focused on substantial equivalence rather than a detailed study report:

• Sample sizes used for the test set and data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment for a test set is mentioned.
• Adjudication method for the test set: No test set or adjudication process is described.
• Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a substantial equivalence claim for a physical device.
• Sample size for the training set: Not applicable, as this is not a machine learning study.
• How the ground truth for the training set was established: Not applicable.

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