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510(k) Data Aggregation

    K Number
    K023925
    Device Name
    MARK I THERMAL IMAGER
    Manufacturer
    IX-DR, INC.
    Date Cleared
    2003-02-11

    (78 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Thermal Imaging is a medical imaging modality for use as an adjunctive procedure to support other diagnostic modalities. For example, thermal imaging of breasts can demonstrate a temperature variance as a method to help clarify findings indicated by mammography or some other diagnostic procedure.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device called the "Mark I Thermal Imager." It primarily discusses regulatory approval and does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide the specifics of the performance testing or clinical studies.

    Therefore, I cannot fulfill your request for the information outlined in your prompt using only the provided text. The document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Information on experts used to establish ground truth.
    4. Adjudication method for a test set.
    5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Information on a standalone algorithm performance study.
    7. The type of ground truth used.
    8. Sample size for a training set.
    9. How ground truth for the training set was established.

    The "Indications for Use" section (page 2 of the input) briefly describes the purpose of thermal imaging as an "adjunctive procedure to support other diagnostic modalities" and its ability to "demonstrate a temperature variance as a method to help clarify findings indicated by mammography or some other diagnostic procedure." However, this is a statement of intended use, not a report of study results or acceptance criteria.

    To obtain the information you are looking for, you would typically need to consult the 510(k) premarket notification submission itself, which would contain the detailed study results and performance data.

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