(177 days)
Removable Cuff Abutments are screw retained endosseous dental implant abutments and are intended to function as an anchor to which prosthetic devices may be attached using either dental oement or a lingual screw.
They are indicated for use on endosseous implants placed in the mandible or maxilla for support of fixed bridgework, removable bridgework or free standing single tooth replacements.
A Removable Cuff Abutment is a two piece titanium alloy abutment with a separate titanium alloy retaining screw. Each Removable Cuff Abutment is composed of one abutment core body and one removable cuff. Removable Cuff Abutments will be offered as fixed abutments and as pre-angled (15 and 25 degree) abutments for use with both cement and screw retained prosthetics. Abutments will be available in three different diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Flare diameters of cuffs will range from 4.0 to 6.5mm and cuff heights will range from 0.5 mm. A new feature is the addition of a transverse (lingual) screw to some designs. This feature will permit attachment of screw retained prostheses in addition to cement retained prostheses. Removable Cuff Abutments will be packaged with or without the transverse (lingual) screw components.
The provided text is a 510(k) summary for a dental implant abutment and does not contain information about an AI device or a study involving acceptance criteria and device performance as typically understood for AI/ML medical devices. The document describes a "Removable Cuff Abutment" and its comparison to predicate devices, focusing on manufacturing, material, and design characteristics.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these are not discussed in the provided text.
The section titled "Performance Data" states: "Bench top testing demonstrated the equivalence of the Removable Cuff Abutment to the predicate devices." This is the only mention of performance or testing, and it refers to physical bench testing, not an AI model's performance.
§ 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.