(87 days)
For use in selected fully edentulous and partially edentulous arches
The additional fixture provided for by this 510(k) is added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. The implant is a root-form uncoated screw. It is cylindrical in shape. The coronal portion has a minute thread - microthread - and the apical part a magnified thread - Macrothread. It is made from commercially pure titanium. It has a defined surface texture achieved through titanium oxide grit blasting. The component is intended for use in selected fully edentulous and partially edentulous arches.
This 510(k) summary (K991053) describes an additional component, the MicroMacro fixture, for the Astra Tech Implants - Dental System. It is a premarket notification for a medical device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML algorithm.
The document pertains to the regulatory clearance of a physical dental implant component, made of commercially pure titanium, with a specific design (microthread and macrothread). The FDA's review determined substantial equivalence to legally marketed predicate devices, allowing its market entry.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or human reader effectiveness with AI. These concepts are relevant to the evaluation of AI/ML-driven medical devices, not to a physical dental implant as described in this 510(k) summary.
§ 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.