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510(k) Data Aggregation

    K Number
    K153111
    Device Name
    TOUAREG CloseFit™ UNP 2.75mmD
    Manufacturer
    Adin Dental Implants Systems Ltd.
    Date Cleared
    2016-05-06

    (191 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K141450,K112585,K140293
    Why did this record match?
    Reference Devices :

    K141450, K112585

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 14801:2007Fatigue 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.

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