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The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System (Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Pressure Products) compression devices or as a stand alone device to assist in the control of bleeding following catheterization or cannulation procedures. Following achieving hemostasis the D-Stat Dry Bandage may be detached from the D-Stat Clamp Accessory and left in place for up to 24 hours and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The D-Stat Clamp Accessory consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride secured to a compressible translucent pad and plastic base. The device is designed for attachment to several commercially available femoral access compression devices or as a standalone device. After hemostasis has been achieved, the lyophilized pad may be removed from the Clamp Accessory base, covered with a provided adhesive bandage, and left in place for up to 24 hours.

The provided text is a 510(k) Summary for the D-Stat Clamp Accessory. It describes the device, its intended use, and states that it is substantially equivalent to previously marketed devices. However, it explicitly states under "Summary of Non-Clinical Testing" that only "Tests conducted included assessment of the ability to separate the lyophilized pad from the Clamp Accessory Base and a biocompatibility assessment of new materials." There are no clinical performance testing or studies described in this document to establish specific acceptance criteria for efficacy or safety (beyond biocompatibility) of the D-Stat Clamp Accessory itself.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text. The document focuses on regulatory equivalence based on technological characteristics and indication of use in comparison to predicate devices, rather than detailed performance studies for this specific device.

The "Summary of Non-Clinical Testing" listed is very specific and limited to mechanical separation and biocompatibility, not clinical effectiveness.

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