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The family of impervious bags for endoscopic retrieval of tissue are single-use The family of importantes for the collection and extraction and extraction of tissue during laparoscopic surgical procedures. The family includes three sizes of impervious bags for the endoscopic retrieval of tissue: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).

Single-use disposable device used as a receptacle for the collection and extraction of tissue during laparoscopic surgical procedures.

This document appears to be a 510(k) summary for a medical device (laparoscopic specimen retrieval bags). It does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) that would be required to answer your specific questions about device performance and its proof through a study.

The provided text focuses on:

• Administrative details: Applicant, contact person, preparation date, trade name, common name, classification, predicate devices.
• Device description: Single-use disposable device for tissue collection and extraction during laparoscopy.
• Intended Use: Specifies the purpose and the different sizes of the bags.
• Substantial Equivalence: States that the device is substantially equivalent in design and materials to predicate devices.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
• Indications for Use form: Reiterates the intended use.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and the study proving device performance because that information is not present in the provided text.

This type of 510(k) submission typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical study data with specific performance metrics and acceptance criteria for this particular device's clinical efficacy. While performance testing (e.g., burst strength, material compatibility) would have been conducted for the submission, the specific details of those tests (acceptance criteria, sample sizes, ground truth, etc., as you've requested) are not usually included in the public 510(k) summary.

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