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The Mostdi ™ dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.

Mostdi™ dental implant system consists of one piece screw type endosseous dental implants manufactured from titanium alloy and intended to provide support for prosthetic devices such as bridges and removable dentures in order to restore a patient's chewing function.

The Mostdi Dental Implant System (K132178) is a dental implant system consisting of one-piece screw-type endosseous dental implants made from titanium alloy. It is intended to support prosthetic devices like bridges and removable dentures for treating partial or full edentulism. The device can be immediately loaded if good primary stability and appropriate occlusal loading are achieved.

The manufacturer did not conduct a clinical study to prove the device meets acceptance criteria. Instead, substantial equivalence was claimed based on a comparison to predicate devices, supported by non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

The submission explicitly states that the substantial equivalence claim relies on having "the same device characteristics as the predicate devices," with similar "intended use, material, design and use concept." No specific numerical acceptance criteria or performance metrics derived from a study are provided beyond the general assessment of similarity to predicate devices. The "reported device performance" is essentially that it passes various non-clinical tests and is deemed substantially equivalent to existing, legally marketed devices.

2. Sample Size Used for the Test Set and Data Provenance:

No clinical test set was used for a study comparing the device against acceptance criteria in the context of this 510(k) submission. The submission relies on non-clinical benchmark testing (e.g., fatigue, sterilization, shelf life, biocompatibility, surface analysis) and a a comparative review against predicate devices. Therefore, there is no sample size for a "test set" in the traditional sense of a clinical study, nor specific data provenance (country of origin, retrospective/prospective) for such a set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. As no clinical test set was used to establish an efficacy or performance ground truth, there were no experts establishing ground truth for such a test set. The substantial equivalence determination was made by the FDA based on the provided technical documentation and comparison to predicate devices, and internal FDA reviewers are the "experts" in this context.

4. Adjudication Method for the Test Set:

Not applicable. Without a clinical test set, there is no adjudication method.

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 device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant.

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

Not applicable. This is a physical medical device (dental implant), not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" used in this submission is the established safety and effectiveness profile of the identified predicate devices. The manufacturer's claim of substantial equivalence is based on demonstrating that the Mostdi Dental Implant System is as safe and effective as, and performs as well as, the legally marketed predicate devices. The non-clinical tests (fatigue, sterilization, shelf life, surface analysis, biocompatibility) serve to confirm the physical and biological characteristics align with the expected performance of an endosseous dental implant made from the specified material, which is consistent with the predicates.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. There is no concept of a "training set" as would be found in algorithm development for AI/ML.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set, there is no ground truth established for it.

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