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The FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

The FRIADENT Implant Systems consist of root-formed threaded screws made from commercially pure titanium and coated with FRIADENT plus surface.

This submission (K073075) is for a Dentsply International dental implant system (FRIADENT Implant Systems) seeking to expand its indications for use to include immediate loading applications. The information provided heavily focuses on regulatory details and equivalency to predicate devices, rather than detailed performance study results that would typically be found in a clinical study report.

Therefore, the requested information for acceptance criteria and a study proving the device meets those criteria cannot be fully provided from the given text because the submission is primarily based on expanding indications for existing, legally marketed devices, and thus does not present new performance data in the typical format of a clinical trial.

The submission explicitly states: "No changes have been made to these implant systems. This submission expands the indications for use. Therefore, it was determined that no additional biocompatibility testing was necessary. We believe that the performance data provided and the research and development and marketing history of the unchanged device support the safety and effectiveness of the FRIADENT Implant Systems for the indicated uses."

This implies that the "acceptance criteria" are likely based on the historical performance and established safety and effectiveness of the existing implant systems for their original indications, and the "study" is the cumulative body of evidence from those existing devices and their marketing history, rather than a new dedicated study specifically proving immediate loading efficacy in a structured contemporary manner.

Given this context, I will address the requested points to the best of my ability, highlighting where the information is not present or implied by the nature of the submission.

Acceptance Criteria and Device Performance

Since this is an expansion of indications for existing devices, explicit, quantitative acceptance criteria and specific "reported device performance" from a new study designed to meet those criteria are not provided. The implicit acceptance criterion is that the devices, when used for immediate loading, maintain the safety and effectiveness demonstrated for their prior indications.

Study Details (Based on the provided text):

As explained above, a dedicated "study" in the traditional sense (e.g., a new prospective, randomized controlled trial with detailed endpoints) proving the device meets new acceptance criteria for immediate loading is not detailed in this 510(k) summary. The submission relies on the existing performance data and marketing history of the unchanged devices.

1. Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" for new immediate loading performance. The "performance data" mentioned likely refers to cumulative clinical experience and studies related to the existing devices for their original indications. No details on country of origin or retrospective/prospective nature are provided for this cumulative data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a new test set requiring expert ground truth for this submission. The safety and effectiveness determination is based on a regulatory review of existing data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.

4. 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 device is a physical dental implant, not an AI or imaging diagnostic tool, so MRMC studies are irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the expanded indications is indirectly derived from the outcomes data and clinical experience associated with the existing, unchanged FRIADENT implant systems over their documented marketing history. This historical performance, validated by clinicians in practice, serves as the basis for asserting safety and effectiveness when expanding indications.

7. The sample size for the training set: Not applicable. This is not an AI or machine learning device that requires a training set.

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

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