(289 days)
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.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices) | Reported Device Performance |
|---|---|---|
| Material Composition | Made from Ti6Al4V ASTM F-136 (same as predicates) | Ti6Al4V ASTM F-136 (matches predicate material) |
| Design Type | One-piece screw-type endosseous dental implant (same as predicates) | One-piece screw-type (matches predicate design type) |
| Implant Surface | Roughened (light sand blast & acid etch), comparable to blasted/clean surfaces of predicates | Roughened - light sand blast & acid etch (considered comparable to predicate surfaces) |
| Dimensions | Diameters and lengths within ranges comparable to predicate devices | OSH: 2.5, 3.0 dia. & 8,10,12,13,14,16 length; MXO: 3.5 dia. & 8, 10 length; PEO: 3.8 dia. & 10, 12, 14, 16, 18 length; POH: 2.5, 3.0 dia. & 8, 10, 12, 13, 14, 16 length; MXP: 3.5 dia. & 8, 10 length; PEP: 3.8 dia. & 10, 12, 14, 16, 18 length (comparable to predicates) |
| Intended Use | Support for removable dentures and fixed bridges for partial/full edentulism; immediate loading possible with good stability and appropriate occlusal loading (comparable to predicates) | Matches intended use of predicate devices, including immediate loading conditions. |
| Biocompatibility | Biocompatible for dental implant use (implied by material and predicate equivalence) | Biocompatibility testing performed (details not provided in summary, but indicated as reviewed) |
| Sterilization | Sterilization validation (implied by predicate equivalence) | Sterilization validation performed (indicated as reviewed) |
| Shelf Life | Stable over a specified shelf life (implied by predicate equivalence) | Shelf life testing performed (indicated as reviewed) |
| Fatigue Performance | Meets fatigue requirements (e.g., ISO 14801/static test) for dental implants | Fatigue tests to ISO 14801/static test performed (indicated as reviewed) |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.