(49 days)
The 5.0 x 6.0mm Bicon dental implant is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices to restore the patient's chewing function.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for a dental implant.
It informs Dr. Vincent Morgan that their device, "The 5.0 x 6.0mm Dental Implant," has been found substantially equivalent to a legally marketed predicate device. This letter approves the marketing of the device, but it does not include the underlying study data, acceptance criteria, or performance metrics.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Results of standalone algorithm performance.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This FDA letter is a regulatory approval document based on a review of submitted information, not a publication of the study data itself.
§ 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.