(136 days)
The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments. Abutments are placed on dental implants to provide support for dental restorations. Temporary abulments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.
This looks like a 510(k) summary for a dental device, specifically "Straumann RC Temporary Abutments." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed studies of performance against specific acceptance criteria for a novel AI/software medical device.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.
The document primarily focuses on:
- Identification of the device: Straumann RC Temporary Abutments.
- Identification of a predicate device: RC Temporary Abutments, K070478.
- Intended Use: For temporary restorations of single crowns and bridges for up to six months with Straumann RC Bone Level Dental Implants.
- Technological Characteristics: Stating that the proposed abutments are substantially equivalent to marketed devices, with identical intended use, material composition, basic design, and fundamental operating principles.
- FDA Clearance: The letter from the FDA confirms the device is substantially equivalent to legally marketed predicate devices.
To directly answer your request based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence to a predicate device based on identical intended use, material, design, and operating principles, rather than reporting specific performance metrics against pre-defined acceptance criteria.
- Sample sized used for the test set and the data provenance: Not available. No specific test set or study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. This type of information is not relevant for a 510(k) summary of a physical dental abutment.
- Adjudication method: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical dental abutment, not an AI or software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.