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Opportunity Inc.'s I.V. Start Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing I.V. start procedures.

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I cannot fulfill this request. The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for various medical kits, including an "Opportunity I.V. Start Kit." This type of document declares a device substantially equivalent to a predicate device already on the market, allowing it to be marketed.

However, a 510(k) clearance letter does not contain details about acceptance criteria or specific study results for device performance, especially in the context of advanced AI models. The text focuses on regulatory compliance, classification, and the substantial equivalence determination based on existing regulations and predicate devices.

Therefore, the information needed to answer your questions (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided document.

To answer your questions, I would need a different type of document, such as a clinical study report, a scientific publication detailing the device's performance, or a more comprehensive technical submission to a regulatory body that outlines the validation studies.

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