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510(k) Data Aggregation

    K Number
    K082545
    Device Name
    STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
    Manufacturer
    INSTITUT STRAUMANN AG
    Date Cleared
    2008-10-17

    (44 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K052272,K061277,K081005
    Why did this record match?
    Device Name :

    STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS

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

    Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures.

    The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

    The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cement-retained or directly veneered.

    Device Description

    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, abutments and surgical and prosthetic parts and instruments.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment:

    Summary of Device Acceptance Criteria and Study Findings

    The provided 510(k) summary for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. It does not present a study with specific acceptance criteria and reported device performance metrics in the typical sense of a clinical trial or performance study showing quantifiable outcomes like sensitivity, specificity, accuracy, etc.

    Instead, the "acceptance criteria" are implicitly met by demonstrating that the new devices share the same fundamental characteristics as their predicates.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied for Substantial Equivalence)Reported Device Performance (as stated in the document)
    Identical intended use as predicate devices."The intended use is identical to the predicate devices."
    Same material composition as predicate devices."The proposed abutments have the same material composition..."
    Basic design similar to predicate devices."...basic design..." (similar to predicates, implied)
    Fundamental operating principles similar to predicate devices."...and fundamental operating principles to the currently cleared devices."

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not applicable. The submission is based on a comparison of characteristics to predicate devices, not a clinical test set with patient data.
    • Data Provenance: Not applicable. There is no test set in the traditional sense of a study involving data from patients or a specific geographic region.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    • Number of Experts: Not applicable. There is no test set requiring expert ground truth establishment for performance metrics.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. There is no test set for which adjudication would be required.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    • MRMC Study: No. This type of study is not mentioned or implied in the 510(k) summary. The submission focuses on substantial equivalence based on material, design, and intended use, not a comparison of human reader performance with or without AI assistance.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    • Standalone Study: No. This device is a physical dental abutment, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: Not applicable in the context of typical software or diagnostic device evaluations. The "ground truth" for this submission is the established legally marketed status and characteristics of the predicate devices. The new devices are deemed "substantially equivalent" if their characteristics match or do not raise new questions of safety or effectiveness compared to the predicates.

    8. The Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable. This device is a physical dental abutment, not a machine learning model that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

    Conclusion:

    This 510(k) submission for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment falls under the category of substantial equivalence demonstration for a physical device. It does not involve a traditional performance study comparing a device against specific acceptance criteria using a test set with expert-established ground truth, as would be common for diagnostic software or AI-powered devices. The "study" here is the comparison of the new device's characteristics (intended use, material, design, operating principles) to those of legally marketed predicate devices. The FDA's acceptance (clearance) signifies that this comparison demonstrated substantial equivalence.

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