(343 days)
IMZ implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulousareas to be restored with fixed arches, and es and es a loss to totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
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The provided text is a 510(k) clearance letter from the FDA for a dental implant device called "IMZ Twin Plus Screw." This document primarily deals with regulatory clearance and indications for use, not a study demonstrating the device meets specific acceptance criteria with performance metrics.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Information about sample size, data provenance, or test sets.
- Details about experts used for ground truth or adjudication methods.
- Information about Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness.
- Data on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes).
- Sample size or ground truth establishment for a training set.
The document is a legal notification that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls. It does not describe the specific performance testing or the results of such testing against acceptance criteria that would typically be detailed in a clinical or performance study report.
§ 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.