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The AbsorbaTack™ and Applicator are indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

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This is an FDA Premarket Notification (510(k)) letter for a medical device. This type of document primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria, expert reviews, or specific sample sizes as would be found in a clinical study report.

Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth establishment is not available within the provided text.

The document states that the FDA has determined the device "AbsorbaTack™ and Applicator" is "substantially equivalent" to legally marketed predicate devices, which is the primary "acceptance criteria" for a 510(k) submission. This determination is based on the information provided in the premarket notification, but the specifics of that submission (e.g., bench testing, animal studies, or limited human data comparing to a predicate) are not detailed here.

In summary, none of the specific requested information regarding performance studies is present in this 510(k) letter.

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