(191 days)
TOUAREG CloseFit™ UNP 2.75mmD implants are indicated to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. For single-stage or two-stage procedures. For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When an one-stage surgical is applied, the implant maybe immediately loaded when good primary stability is achieved and thefunctional load is appropriate.
The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system is comprised of a tapered core implant with a spiral tap, with unique tip and triple lead thread design (3x1mm).
The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system offers a unique, strong and solid conical-hex connection.
All Touareg CloseFit™ implants feature the OsseoFix™ surface treatment The TOUAREG CloseFit™ UNP 2.75mmD implant is provided with a diameter of 2.75mm and lengths of 10, 11, 13, 16 and 18 mm.
The TOUAREG CloseFit™ UNP 2.75mmD implants are two piece devices whereas the implant is to be used in combination with cover screws, healing abutments and abutments.
The TOUAREG CloseFit™ UNP 2.75mmD implants, abutments, and abutment fixation screw are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
The provided document is a 510(k) premarket notification for a dental implant device, the TOUAREG CloseFit™ UNP 2.75mmD. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
Based on the information provided, the following can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/CADe device. Instead, it demonstrates equivalence to predicate devices through non-clinical performance data (fatigue testing). The "performance" here refers to the device's mechanical integrity under simulated conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices based on fatigue testing according to ISO 14801:2007 | Fatigue test was performed according to ISO 14801:2007 on the TOUAREG CloseFit™ UNP 2.75mmD dental implants and showed equivalence to the predicate devices. |
2. Sample Size for Test Set and Data Provenance
The document does not describe a "test set" in the context of evaluating an AI/CADe device. The performance evaluation is based on non-clinical fatigue testing of the physical dental implant device. The sample size for this physical testing is not specified.
Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as this is laboratory testing of a manufactured medical device, not analysis of patient data.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the evaluation is not for an AI/CADe system requiring expert-established ground truth from medical images or clinical data. The judgment of "equivalence" is made by the FDA based on the submitted non-clinical test reports.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" requiring expert adjudication in the context of an AI/CADe device performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done. This section is not relevant as the device is a physical dental implant, not an AI/CADe system intended to assist human readers.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study was not done. This section is not relevant as the device is a physical dental implant, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by conformance to a recognized international standard (ISO 14801:2007 for fatigue testing) and comparison to predicate devices, demonstrating mechanical equivalence. There is no biological or pathological "ground truth" in the typical sense for an AI/CADe device.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical dental implant, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. The device is a physical dental implant, not an AI algorithm.
§ 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.