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The SunmedTM disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.

disposable angio-closure pads is composed of compression bulb, The compression band and infusion mouth. Compression bulb is made from medical Polyurethane. Compression band is made from medical adhesive tape. Infusion mouth is made from medical Polycarbonate.

The provided text describes a medical device called "SunmedTM Disposable Angio-Closure Pads" and its 510(k) submission to the FDA. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics typically associated with AI/ML or diagnostic devices.

The document primarily focuses on the device's substantial equivalence to a predicate device (Safeguard™ 24cm pressure assisted dressing) based on:

• Intended Use: Both assist in obtaining and maintaining hemostasis.
• Technological Characteristics: Equivalent in terms of fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.

The non-clinical testing performed includes biocompatibility, package penetration, asepsis, aging, EtO and ECH residue, and bench testing. These are primarily related to safety, sterility, and material properties, not performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested information in bullet points 1 through 9 because the provided document does not contain data on acceptance criteria, reader studies, ground truth establishment, or performance statistics typically found for diagnostic or AI-enabled medical devices.

The relevant sections of your request that are explicitly or implicitly addressed as "not applicable" in this document are:

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Evaluation was not applicable."
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Clinical Evaluation was not applicable." (implies no standalone performance study in a clinical context)
• 7. The type of ground truth used: Not applicable as no clinical performance study was done.
• 8. The sample size for the training set: Not applicable as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

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