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The Leone Implant System is indicated for single or multiple tooth replacement, or for use in terminal or intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It can work as an abutment system for partial/total prosthetic restorations or as an anchorage system for removable prosthodontics.

The Leone implant system is composed of a fixture and an abutment joined together by a self locking tapered connection due to a Morse cone and a hexagon. The prosthesis is then placed over the abutment.

The provided text describes a 510(k) premarket notification for the "Leone Implant System," a dental implant device. The submission focuses on establishing substantial equivalence to existing legally marketed predicate devices rather than proving specific performance criteria through a study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document.

The document states that the conclusion is based on:

• Intended Use: Consistent with predicate devices.
• Materials: Titanium (same as predicate devices).
• Biocompatibility: Biocompatible (same as predicate devices).

The acceptance criteria for a 510(k) submission like this are primarily demonstrating that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.

Summary of what is present:

• Acceptance Criteria and Reported Device Performance: Not presented as a list of quantitative metrics. The "acceptance criteria" are effectively demonstrating substantial equivalence in intended use, material, and biocompatibility, which the submitter claims is met.
• Study Details: No study is described that tests the device against specific performance acceptance criteria. The submission is a comparison to predicate devices.
• Sample Size for Test Set: Not applicable, as no performance study is detailed.
• Data Provenance: Not applicable.
• Number of experts and qualifications: Not applicable.
• Adjudication method: Not applicable.
• MRMC study: Not applicable.
• Standalone performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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