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The Modified SPACEMAKER* System:

SPACEMAKER* Structural Balloon Trocar

The SPACEMAKER* Structural Balloon Trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.

SPACEMAKER* Blunt Tip Trocar

The SPACEMAKER* Blunt Tip Trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.

SPACEMAKER* Dissection Balloon

The SPACEMAKER* Dissection Balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.

The Modified SPACEMAKER* System consists of a balloon dissector and trocar which are used in conjunction to provide a port of access and tissue separation during laparoscopic surgery.

The provided text is a 510(k) Summary for a medical device called the "Modified SPACEMAKER* System." It details the device's description, indications for use, and identifies predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes for testing or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them from the provided text. The document is primarily a regulatory submission outlining the device's features and intended use in comparison to existing devices, not a scientific study report.

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