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The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.

Wound retraction device providing thoracic and abdominal access and protection from wound contamination.

This document is a 510(k) summary for the Covidien Surgisleeve™ Wound Protector, a medical device designed for surgical access and wound protection. It confirms that the device is substantially equivalent to a previously cleared predicate device (K140064). The document outlines the intended use, device description, materials, and performance data from in-vitro and in-vivo tests but does not present acceptance criteria or detailed study results for an AI/CADe device.

Therefore, the requested information cannot be extracted from the provided text. The document describes a traditional medical device (wound protector) and its regulatory clearance process, not a device involving AI or machine learning that would have acceptance criteria and a study design as typically requested for AI/CADe systems.

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