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510(k) Data Aggregation

    K Number
    K110481
    Device Name
    TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
    Manufacturer
    ASI MEDICAL, INC.
    Date Cleared
    2012-04-05

    (412 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

    The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

    Device Description

    The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any such criteria.

    The document is a 510(k) premarket notification letter from the FDA regarding the "Triton Self Contained Dental System." It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

    The document does not contain:

    1. A table of acceptance criteria or reported device performance.
    2. Information about sample sizes for a test set, data provenance, or training set.
    3. Details on the number or qualifications of experts used for ground truth.
    4. Adjudication methods.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
    6. A standalone algorithm performance study.
    7. The type of ground truth used.
    8. How ground truth for a training set was established.

    This type of FDA letter primarily confirms the substantial equivalence of a new device to existing ones, rather than detailing specific performance studies against acceptance criteria in the format requested.

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