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The MGB LAPBAG sterile retrieval bag for Endoscopic surgery is intended to be used for:

• -General surgery
• Abdominal surgery - .
• Gynecological surgery -
• Thoracic minimally invasive procedures. -

The Specimen Retrieval Bag is indicated for use in endoscopic procedures to allow tissues or debris to be removed from the abdominal cavity.

Not Found

I am sorry, but the provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to MGB Endoskopische Geräte GmbH Berlin regarding their MGB Disposable Retrieval Bag/LAPBAG. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, study methodologies, or ground truth details.

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