(139 days)
The proposed MiniFix Implant system consists of MiniFix One and MiniFix Ball implants.
The MiniFix One implants are indicated to provide support for single unit dental prostheses in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The MiniFix One implant must be splinted if two or more are used adjacent to each other. The MiniFix One implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
The MiniFix Ball implants are intended to be placed throughout the maxillary and mandibular arches to provide support for multi-unit restorations on long-term or short term fixation of upper and lower dentures. Immediate loading should only be done in the presence of primary stability and appropriate occlusal loading.
Built in Grade 5 ELI Titanium Alloy and treated with RBM technology, the proposed MiniFix implants are designed for both provisional and permanent implementations of singleunit or multi-unit restorations.
The major component of the MiniFix Implant consists of a one-piece, root-form, self-tapping screw. This implant is offered in two models, each with its own applicability: MiniFix Ball and MiniFix One.
The MiniFix Ball implant provides a spherical head that allows for easy placement and removal of both partial and full dentures. Additionally, this model is available in an option without the RBM treatment for use in transitional applications (temporary dentures).
Minifx One is a single piece implant that provides a flat head for permanent installation of single crowns.
The provided text describes a 510(k) submission for a dental implant device called "MiniFix Implant". It details the device's description, intended use, and a comparison to predicate devices, but does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of performance metrics like accuracy, sensitivity, or specificity.
The submission focuses on establishing substantial equivalence to existing predicate devices (MDI MII One-Piece Implant 2.9mm, Inclusive Mini Implant, and Mini Drive-Lock Dental Implant System) based on materials, design, surface treatment, fatigue testing, and risk management. The "Non-Clinical Test Data" section explicitly states: "Minifx Implants do not introduce new issues for materials, design, surface treatment, fatigue testing and risk management that have not been addressed in all other substantially equivalent predicate devices." This indicates that the regulatory approval relies on the similarity to already approved devices rather than new performance studies with acceptance criteria for the device itself.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and the reported device performance: No such criteria or performance data is presented in the context of study outcomes.
- Sample size used for the test set and the data provenance: There is no test set described for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no performance test set.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory submission for a medical device seeking substantial equivalence, not a report on a performance study with detailed clinical or non-clinical evaluation metrics and acceptance criteria.
§ 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.