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The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic procedures. The device is intended to be used after the establishment of a pneumoperitoneum.

The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic procedures. The device is intended to be used after the establishment of a pneumoperitoneum. The device is manufactured entirely from stainless steel is widely used in the medical field and biocompatibility is assured

The provided 510(k) summary for the "Maher Abdominal Wall Elevator" by Cook Urological, Incorporated and COOK OB/GYN® does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

This 510(k) summary is for a medical device (an abdominal wall elevator) that is likely a mechanical instrument. The typical "acceptance criteria" and "study" described in the input pertain to diagnostic algorithms or AI-driven devices, which require performance metrics like sensitivity, specificity, AUC, etc., and detailed clinical validation studies.

The information provided focuses on demonstrating substantial equivalence to a predicate device based on:

1. Indications for use: Elevate/retract the abdominal wall for low-pressure laparoscopic procedures after pneumoperitoneum.
2. Design and Construction: Entirely made from stainless steel.
3. Materials equivalence: Stainless steel, which is widely used and biocompatible.
4. Manufacturing quality: Manufactured according to specified process controls and a Quality Assurance Program.

Therefore, I cannot fill out the requested table or answer the questions because the document describes a traditional mechanical medical device, not an AI/diagnostic algorithm that would have such performance metrics and studies.

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