(423 days)
Magnacap is a magnetic abutment for implant retained dental and craniofacial prosthesis and root supported overdentures. Magnacap is engineered to fit several commercially available implant fixtures.
Magnacap is a magnetic abutment for implant retained dental and craniofacial prosthesis and root supported overdentures. Magnacap is engineered to fit several commercially available implant fixtures.
This looks like an FDA 510(k) clearance letter for a dental device called "Magnacap." It's a regulatory document and does not contain the kind of detailed study information you're asking for.
Specifically, the document does not contain any of the following information:
- A table of acceptance criteria and reported device performance
- Sample sizes used for test or training sets
- Data provenance (country of origin, retrospective/prospective)
- Number or qualifications of experts for ground truth
- Adjudication method for the test set
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study
- Results of a standalone (algorithm only) performance study
- Type of ground truth used (expert consensus, pathology, outcomes data)
- How ground truth for the training set was established
This document primarily states that the FDA has reviewed the 510(k) submission for the Magnacap device and determined it is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general regulatory requirements but does not delve into the specifics of performance testing or clinical studies.
§ 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.