(62 days)
Nobel Biocare TiUnite® Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare TiUnite® Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare TiUnite® Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
TiUnite® implants are indicated for use in soft bone whenever immediate or early loading is applied. The TiUnite® implants are preferred in these soft bone indications because bone formation is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.
Nobel Biocare TiUnite" Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.
Til hite Implants machined from titanium and have a surface treatment consisting of a thin, uniform titanium oxide (TiUnite") layer. Nobel Biocare TiUnite Implants are available with a straight or tapered contour.
Nobel Biocare TiUnite" Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion where good initial stability can be obtained.
Due to a more rapid formation and greater amount of bone to implant contact during healing. Nobel Biocare's TiUnites surfaced implants result in faster and stronger ossecuntegration and better maintenance of the initial implant stability than machined titanium implants. When piaced in soft bone and immediately loaded, the faster and stronger osseointegration of Nobel Biocare's TiUnites surfaced implant results in a higher success rate compared to machined implants
The provided document is a 510(k) summary for the TiUnite Implants by Nobel Biocare. This submission is for a dental implant, which is a medical device. The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is typically associated with the evaluation of artificial intelligence (AI) or diagnostic image analysis devices.
This 510(k) summary for a dental implant does not contain any information related to AI/ML device performance or clinical studies with human readers. It is a regulatory submission demonstrating substantial equivalence to a predicate device based on material, design, and intended use, not on diagnostic performance against a ground truth.
Therefore, I cannot extract the requested information from the provided text because it is not present in this type of regulatory document.
Here's why the requested information is not applicable or available:
- Acceptance Criteria & Reported Device Performance (Table): This document describes a physical medical device (dental implant). Its "performance" is related to its mechanical properties, biocompatibility, and clinical outcomes (osseointegration, stability, success rates), not diagnostic accuracy metrics like sensitivity or specificity that would have acceptance criteria for an AI device.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are all related to studies designed to evaluate the diagnostic accuracy, reliability, or clinical effectiveness of a diagnostic or AI-powered device, often in comparison to human readers or a ground truth. The TiUnite implant is a therapeutic device, not a diagnostic one, and its 510(k) submission does not include such performance studies.
- Type of Ground Truth: Ground truth (e.g., pathology, expert consensus) is established for AI or diagnostic devices to verify their output. This is not relevant for a dental implant's regulatory submission.
- Sample Size for Training Set & Ground Truth for Training Set: These relate to the development and validation of AI models, which are not part of this dental implant submission.
In summary, the provided text does not contain the information requested because it pertains to a traditional medical device (dental implant) and not an AI or diagnostic image analysis 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.