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510(k) Data Aggregation

    K Number
    K131689
    Device Name
    MRI MARKER
    Manufacturer
    C4 IMAGING LLC
    Date Cleared
    2013-11-20

    (163 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K040766,K103449,K083274,K010621
    Predicate For
    K171487
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (1851). Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.

    Device Description

    C4 Imaging's MRI Marker™ consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine (CoCl2:NAC) solution. It is used as an accessory to radionuclide sources (seeds) during prostate brachytherapy procedures. The length of the capsule is 5.5 mm and the diameter is 0.8 mm.

    AI/ML Overview

    Here's an analysis of the provided text regarding the MRI Marker, addressing your requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text focuses on the safety and effectiveness of the MRI Marker, rather than specific performance metrics against pre-defined acceptance criteria in the traditional sense of diagnostic accuracy or sensitivity/specificity. The criteria are largely related to established medical device standards and the device's intended function.

    Acceptance Criterion (Implicit)Reported Device Performance
    Sterilization Efficacy (Sterility Assurance Level - SAL)Validated to provide a Sterility Assurance Level (SAL) of 10-6 (per ISO 11137).
    BiocompatibilityNonirritant, nontoxic, with no concerns for long-term safety (per ISO 10993-1, addressed through in vivo and in vitro tests for irritation, sensitization, cytotoxicity, sub-acute and sub-chronic toxicity, and implantation). Animal testing also indicated a very low potential for toxicity.
    MRI Safety (Induced Displacement Force, Torque, Heating)Labeled as MR Conditional. No induced displacement force or torque observed. Not expected to pose a hazard (per ASTM F2052, F2213, F2119, F2182).
    Radiographic Visualization (MR Imaging)Phantom prostate imaging testing produced a positive-signal MRI image demonstrating the ability of the MRI Marker to perform the intended use of facilitating localization of adjacent radioactive seeds.
    Radiographic Visualization (X-ray Imaging)X-ray imaging of the seeds and MRI Markers loaded in strands and brachytherapy needles demonstrated the MRI Marker performed as intended in effectively spacing the seeds.
    Effective Spacing of Brachytherapy SeedsX-ray imaging (as above) demonstrated effective spacing. The device description also states its use as an accessory to maintain spacing between radioactive seeds.
    Substantial Equivalence to Predicate DevicesThe technological characteristics are similar to or equivalent to the predicate devices. Differences in design do not raise new issues of safety and effectiveness. (This is the overarching acceptance criterion for 510(k) clearance).

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify a distinct "test set" in the context of diagnostic performance (e.g., a specific number of images or patients for evaluation). The performance demonstrations are through:

    • Sterilization Validation: No explicit sample size mentioned for this, as it's a validation of a process.
    • Biocompatibility Testing: "In vivo and in vitro tests were performed." No specific numbers of samples or animals are provided.
    • MRI Safety Testing: No specific sample size mentioned for the devices tested.
    • Radiographic Visualization: "Phantom prostate imaging testing" (implies one or more phantoms) and "X-ray imaging of the seeds and MRI Markers loaded in strands and brachytherapy needles." No specific number of phantoms, strands, or needles are given.
    • Animal Testing: "Animal testing indicates..." No specific number of animals or data provenance (e.g., country of origin, retrospective/prospective) is provided.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not provided in the document. The studies described are technical performance tests (e.g., sterilization, biocompatibility, MRI compatibility) and visualization tests using phantoms or animal models, rather than clinical studies requiring expert ground truth for interpretation.

    4. Adjudication Method for the Test Set

    This information is not applicable/provided as there is no mention of a human-read test set requiring adjudication in the context of the described performance testing.

    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

    No, an MRMC comparative effectiveness study was not done. The device (MRI Marker) is a physical marker for brachytherapy seeds, not an AI or software algorithm itself that would assist human readers in interpretation.

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

    No, a standalone performance study in the context of an algorithm or AI was not done, as the MRI Marker is a physical medical device, not a software algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for the various tests was primarily based on:

    • Sterilization: Industry standards (ISO 11137) and laboratory verification (e.g., absence of microbial growth).
    • Biocompatibility: Established biological endpoints (e.g., absence of irritation, toxicity) as defined by ISO 10993-1 and observed in in-vitro, in-vivo, and animal models.
    • MRI Safety: Measurement of physical forces (displacement, torque) and temperature changes according to ASTM standards.
    • Radiographic Visualization & Spacing: Direct observation of images (MRI and X-ray) to confirm the presence of a positive signal and appropriate spacing in phantoms and simulated setups.

    8. The Sample Size for the Training Set

    This information is not applicable/provided. The MRI Marker is a physical device and does not involve AI or machine learning algorithms that would require a training set.

    9. How the Ground Truth for the Training Set was Established

    This information is not applicable/provided. As above, there is no training set for this device.

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