(90 days)
The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit is intended to be used by practitioners to select the proper abutment.
The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit consists of trial models of various abutments which are used by the practitioner to select the proper abutment. It can be used in two situations: in a patient's mouth and/or on a plaster model. The abutment selection system is used in a patient's mouth for only 5-10 minutes so that the clinician can determine the proper abutment type and length.
This document is a 510(k) summary for a medical device called the "BRANEMARK SYSTEM® Abutment Selection Kit." It's a pre-market notification from 1996.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Device Identification: Name, address, contact person, product name.
- Predicate Device: K944963 (another abutment selection kit).
- Device Description: Trial models of abutments for selection, used in a patient's mouth for 5-10 minutes or on a plaster model.
- Intended Use: To select the proper abutment.
- Comparison of Technological Characteristics: Stating that the characteristics are "identical" to the predicate, with the only notable difference being a "proposed colorant method... to provide a bright color distinction between the 'trial' abutments and the abutments intended for long-term use."
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies because this document does not contain that type of data.
This document is a regulatory submission for a simple, non-active, non-diagnostic device (trial models for fitting) that is being compared to a substantially equivalent predicate. The type of rigorous performance studies and detailed acceptance criteria typically associated with AI/diagnostic devices (which your questions are geared towards) are not relevant or present in this context.
§ 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.