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The device is intended for the retrieval and removal of excised gallbladders, or other similar tissue specimens, during the course of laparoscopic surgery.

The device consists of a polyurethane specimen container used in conjunction with a stainless steel cone retractor. The excised gallbladder, or other similar tissue specimen, is placed within the specimen bag. The bag is then brought within the confines of the cone retractor. The cone retractor is then used to shield the specimen during trans-abdominal extraction. The device can operate through a variety of trocar port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.

The provided text describes a 510(k) submission for the DeGall II Laparoscopic Gallbladder Extractor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.

The document states: "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to withdraw and contain specimens under conditions in excess of those encountered during normal clinical use." This is a general statement about testing without detailing specific acceptance criteria, method, or results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 as the necessary information is not present in the provided text.

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