(66 days)
The Astra Tech Implants – Dental System are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Astra Tech Implants - Dental System are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Astra Tech Dental Implants are root-formed threaded screws made from commercially pure titanium.
The provided text is a 510(k) summary for the Astra Tech Implants - Dental System, related to a labeling change for "immediate function." It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested information. The document appears to be a regulatory submission for a device modification (change in labeling/intended use for immediate function) rather than a report detailing a new performance study with acceptance criteria.
Missing Information from the Provided Text:
- Table of acceptance criteria and reported device performance: This document does not specify any performance-based acceptance criteria or report device performance against such criteria. The submission is for a labeling change allowing "immediate function," which implies clinical outcomes, but no such data is presented.
- Sample size used for the test set and data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment activity is described.
- Adjudication method for the test set: No test set is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC study is mentioned.
- Standalone (algorithm only without human-in-the-loop performance) study: No such study is mentioned.
- Type of ground truth used: No ground truth is described.
- Sample size for the training set: No training set is described.
- How the ground truth for the training set was established: No training set is described.
§ 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.