(25 days)
Algiseal Pad (calcium alginate pad alone and pad with permeable adhesive backing): Algiseal Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis patients and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, posthemostasis site dressing.
Algiseal Pad - (Varying size, with and without permeable adhesive backing, packaged sterile) Pads may be used alone as a wound dressing. The Pad may also be used with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface. May be used in conjunction with a facility approved, post-hemostasis site dressing.
The provided document is a 510(k) summary for the Algiseal Pad. It details the device's intended use and describes the comparison to predicate devices for assessing substantial equivalence. However, it does not include a study describing acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, or detailed ground truth methodologies as requested.
The document states:
"The Evolution Medical Technologies LLC Algiseal products have been tested and are considered safe and effective. Testing and support data are on file to demonstrate substantial equivalence to predicate devices. Data demonstrates there are no new risks associated with the product."
This general statement indicates that testing was performed to demonstrate substantial equivalence, but it does not provide the specific details of those studies. Therefore, I cannot provide the requested information.
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