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510(k) Data Aggregation

    K Number
    K231259
    Device Name
    iRoot SP Plus
    Manufacturer
    Innovative BioCeramix, Inc.
    Date Cleared
    2023-05-31

    (30 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K082943,K032605,K103190,K080917
    Why did this record match?
    Reference Devices :

    K082943, K032605, K103190

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Permanent obturation of the root canal following vital pulp-extirpation
    • Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
    Device Description

    iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental device (iRoot SP Plus), specifically a root canal filling resin. It addresses the substantial equivalence to a predicate device based on non-clinical tests and the predicate device's clinical history.

    However, the document does not contain information about acceptance criteria or a study proving that an AI/ML-based device meets acceptance criteria.

    The request asks for information related to an AI/ML device's performance, such as:

    1. A table of acceptance criteria and reported device performance (for an AI/ML device)
    2. Sample sizes and data provenance for an AI/ML test set
    3. Number and qualifications of experts for AI/ML ground truth
    4. Adjudication method for AI/ML test set
    5. MRMC study details and effect size for AI assistance
    6. Standalone performance of an AI algorithm
    7. Type of ground truth used for an AI/ML device
    8. Sample size for AI/ML training set
    9. How ground truth for AI/ML training set was established

    Since the provided text is for a root canal filling resin and not an AI/ML device, none of the requested information regarding AI/ML device performance and testing is present. The document focuses on chemical composition, physical properties, and equivalence to existing root canal sealers.

    Therefore, I cannot provide the requested details based on the given input.

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