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510(k) Data Aggregation

    K Number
    K053166
    Device Name
    SINCLAIR ORAL RINSE
    Manufacturer
    SINCLAIR PHARMACEUTICALS LIMITED
    Date Cleared
    2006-05-17

    (184 days)

    Product Code
    NTO
    Regulation Number
    872.5580
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K041482
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SINCLAIR ORAL RINSE helps to prevent and reduce gingivitis, when used as directed. SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate.

    Device Description

    SINCLAIR ORAL RINSE contains Delmopinol hydrochloride, an anti-plaque agent that presents a surface barrier preventing oral bacteria from adhering to and colonizing on tooth surfaces and forming dental plaque. SINCLAIR ORAL RINSE helps prevent the binding of bacteria to the tooth surfaces, thereby interfering with the primary steps of plaque formation.

    AI/ML Overview

    The provided text describes the 510(k) submission for Sinclair Oral Rinse, which is essentially an affirmation of its substantial equivalence to an already marketed device (Decapinol Oral Rinse). This type of submission is common for medical devices that are not "AI/ML-enabled" in the way that typically involves complex algorithms for diagnosis, prognosis, or image analysis.

    Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone performance, and expert qualifications) are not applicable to this submission. The "device" in question is a chemical oral rinse, not a software or AI system.

    Here's a breakdown of the applicable information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not present formal "acceptance criteria" in the way one would for an AI model's performance metrics (e.g., sensitivity, specificity, accuracy against a threshold). Instead, the acceptance criteria are met by demonstrating substantial equivalence to a predicate device.

    Acceptance Criteria (for Substantial Equivalence)Reported Device Performance (as demonstrated by argument)
    Same Intended Use as predicate device"SINCLAIR ORAL RINSE helps to prevent and reduce gingivitis, when used as directed. SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate." This matches the predicate's indication.
    Same Technological Characteristics as predicate device"Sinclair Oral Rinse has the same technological characteristics as the predicate, in that each oral rinse is applied topically to the oral mucosa and gingiva, thus reducing the adherence of colonizing bacteria."
    As Safe and Effective as predicate device"Extensive in vitro and in vivo testing has documented the safety and efficacy of Sinclair Oral Rinse and documentation is enclosed." (A summary of results is noted to be in Attachment 5, which is not provided in the input text.)

    2. Sample size used for the test set and the data provenance

    • Not Applicable: This is a chemical product, not an AI/ML device requiring a test set for algorithm performance. The "testing" mentioned refers to traditional clinical and in-vitro studies for drug/device safety and efficacy. No specific sample sizes for these studies are provided in the excerpt, nor is data provenance (country of origin, retrospective/prospective) for these studies.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not Applicable: No ground truth in the context of AI model evaluation is being established.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

    • Not Applicable: No test set in the context of AI model evaluation.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not Applicable: The device is an oral rinse, not an AI assistance tool for human readers.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    • Not Applicable: The device is an oral rinse, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • Not Applicable: No ground truth in the context of AI model evaluation is being established. The "ground truth" for the efficacy of the oral rinse would be actual clinical outcomes related to gingivitis prevention/reduction, likely measured through clinical assessments in human trials.

    8. The sample size for the training set

    • Not Applicable: This is a chemical product, not an AI/ML device requiring a training set.

    9. How the ground truth for the training set was established

    • Not Applicable: No training set.
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