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    K Number
    K111710
    Device Name
    FULL AUTO TONOMETER MODEL TX-20
    Manufacturer
    CANON, INC.-MEDICAL EQUIPMENT GROUP
    Date Cleared
    2011-09-20

    (92 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Type
    Special
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K023816
    Why did this record match?
    Device Name :

    FULL AUTO TONOMETER MODEL TX-20

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

    The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraocular pressure of the human eye.

    Device Description

    The Canon Full Auto Tonometer TX-20 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure with the help of a full auto-alignment system.

    AI/ML Overview

    The provided text is a 510(k) summary for the Canon Full Auto Tonometer TX-20. It states that the device is substantially equivalent to a predicate device (Canon Full Auto Tonometer TX-F) and details its intended use, but it does not contain specific acceptance criteria, a detailed study design with sample sizes, expert qualifications, or comparative effectiveness results. The document emphasizes substantial equivalence based on performance testing (electrical safety, electromagnetic compatibility) and design control activities, rather than a clinical study establishing new performance metrics.

    Therefore, for aspects of your request related to specific acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC study), the provided text does not contain this information. The response will reflect the information that is present in the document.

    Here's an analysis of the provided text in relation to your request:

    Acceptance Criteria and Device Performance

    The provided document does not explicitly list specific numerical acceptance criteria (e.g., accuracy, precision targets) for the Canon Full Auto Tonometer TX-20, nor does it report detailed performance data against such criteria. Instead, it relies on demonstrating substantial equivalence to an existing predicate device (Canon Full Auto Tonometer TX-F, K023816). The "Performance testing" section vaguely states that "Evaluation performed on the TX-20 demonstrated that it's safe and effective."

    Acceptance CriteriaReported Device Performance
    Not explicitly defined in terms of specific performance metrics (e.g., accuracy, precision, sensitivity, specificity).Substantially equivalent to predicate device Canon Full Auto Tonometer TX-F (K023816) in terms of intended use, safety, and effectiveness.
    Compliance with applicable electrical safety and electromagnetic compatibility standards and guidances.The TX-20 complies with applicable standards and guidances.
    Demonstrates safety and effectiveness.Evaluation performed on the TX-20 demonstrated that it's safe and effective.

    Study Information

    The document does not describe a clinical study in the traditional sense with a test set, training set, or ground truth data. Instead, it refers to "Performance testing" to demonstrate substantial equivalence.

    1. Sample size used for the test set and the data provenance: Not specified. The document mentions "Performance testing" but does not detail the sample size (e.g., number of subjects or measurements) used for any such testing. No data provenance (e.g., country of origin, retrospective/prospective) is provided.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a test set is described. The device's performance is asserted through comparison to a predicate and compliance with technical standards.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or ground truth establishment requiring adjudication is described.

    4. 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 a tonometer, which directly measures intraocular pressure, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The TX-20 is described as a "Full Auto Tonometer," implying standalone (automated) operation to measure intraocular pressure. However, no specific standalone performance metrics (e.g., accuracy against a gold standard) are detailed beyond the claim of substantial equivalence to the predicate.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For a tonometer, "ground truth" would typically refer to measurements taken by a highly accurate reference method, but no such reference or ground truth method is detailed in this submission. The basis for safety and effectiveness is substantial equivalence to the predicate.

    7. The sample size for the training set: Not applicable. This document pertains to a medical device (tonometer) which does not appear to involve machine learning models that require a "training set" in the context of data-driven AI.

    8. How the ground truth for the training set was established: Not applicable, for the reason stated above.

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