(217 days)
The UF(II) Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
- The intended use for the 3.0mm, 3.3mm diameter UF(II) Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- It is intended for delayed loading.
Not Found
The provided text is an FDA 510(k) clearance letter for the UF(II) Narrow Implant System. It primarily addresses the regulatory approval of the device based on substantial equivalence to predicate devices and outlines general regulatory requirements. Crucially, it does not contain the detailed information about acceptance criteria or specific studies proving the device meets those criteria.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This document is a regulatory approval notice, not a detailed technical report or clinical study summary. To obtain the information you're looking for, you would generally need to consult the company's 510(k) submission summary, premarket approval (PMA) application documents, or scientific publications from studies conducted on the device.
§ 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.