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The Applied Wound Protector/Retractor 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.
• Protect against wound contamination during laparoscopic and open surgery.

Applied Medical's Alexis O wound protector/retractors are disposable single-use surgical devices used to establish access to internal body cavities and spaces. The protector/retractors are designed for soft tissue retraction and provide 360 degrees of a circumferential retraction and 360 degrees of protection of the wound margins. The predicate Alexis devices are made in sizes ranging from Small to XLarge that accommodate incisions ranging from 2.5 to 17cm. This submission request clearance for adding an XXL and XXXL sizes to the product family. The XXL is for incisions ranging from 17 to 25cm; the XXXL is for incisions ranging from 25 to 30cm. The protector/retractors have a shelf life of three years and are delivered with a template that is used to determine the incision length for the corresponding retractor chosen for the procedure. Protector/retractors are packaged in a Tyvek pouch placed inside a carton.

The provided text describes the Alexis O Wound Protector/Retractor and its substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore no information of the acceptance criteria and study that proves the device meets the acceptance criteria is described.

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The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.

The Applied Wound Retractors come in-four sizes, small, medium-large and large and in two shapes, round and elliptical. The shape of a wound retractor is defined by its wound retracting ring. The Wound Retractor consists of a wound retractor ring and a wound protecting sheath. The wound retractor ring is molded from a plastic material. The wound protecting sheath is comprised of a cylindrical elastic sheath with a ring at one end. The Wound Retractor package also includes an incision template. The Wound Retractor is a disposable, single-use device and is packaged inside Tyvek/Mylar The would which is standard packaging material for medical products. The packaged product will then be packaged in an outer product carton in 1 to 10 pieces per carton.

This document is a 510(k) summary for a medical device called a "Wound Retractor." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in more detailed performance reports.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes, data provenance, number of experts, qualifications of experts, adjudication method,
• Multi-reader multi-case (MRMC) comparative effectiveness study results,
• Standalone algorithm performance, or
• Details about the ground truth for training or test sets.

The information provided is purely for regulatory clearance based on substantial equivalence, not a detailed technical performance study.

Here's what I can extract from the provided text based on your prompt, even though it doesn't contain the specific performance study details you're looking for:

The document does NOT contain information regarding:

• Acceptance criteria or reported device performance
• Sample sizes for test sets or their data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
• Standalone algorithm (AI) performance (as this is a physical medical device, not an AI/software device)
• Sample size for training sets
• How ground truth for training sets was established

Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document. This 510(k) summary is focused on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting detailed performance study results against specific criteria.

Ask a specific question about this device

Ask a specific question about this device