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The B5-2Q/B5-2LA and B7-2Q/B7-2LA Balloon Catheters are to be used for biliary or pancreatic stone removal and dye injection associated with ERCP.

The balloon catheter is designed to be used as an accessory to Olympus endoscopes. It is introduced to the desired anatomical site through an instrument channel of an endoscope. The Balloon Catheter is constructed of an inflatable balloon, catheter, branch, irrigation port, air feed cap, and stopcock. The B5 series Catheters are 5 French in diameter and designed to be used with minimum 2.0 mm channel endoscopes, while the B7 series balloons are 7 French in diameter and should be used with minimum 2.8 mm channel size endoscopes. They are identified by a color code. For example, B5 series have been identified with the blue color branch and B7 series catheters have the yellow color branch. They are available in two different lengths for the specific needs, which the final letter designates as follow: Q is 1950 mm and LA is 3500 mm.

This 510(k) summary for the Olympus B5/B7 Balloon Catheters does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a premarket notification (510(k)) submission to the FDA, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Olympus B5/B7 Biliary Balloon Catheter K904669).

Therefore, I cannot provide the requested information from the provided text.

Here's a breakdown of why the information is missing:

• Acceptance Criteria/Performance Data: The 510(k) process for this type of device often relies on demonstrating that the new device is "substantially equivalent" to an existing device. This means showing that it has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device. It typically does not involve conducting new clinical studies with specific performance metrics defined as acceptance criteria, unless there are significant technological differences or new indications for use.
• Study Details: Since no new performance study is described, there's no mention of sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The document explicitly states: "the subject Olympus B5/B7 Series Balloon Catheters do not incorporate any significant change in the design, specifications, intended use, or method of operation that could affect the safety or efficacy of the subject devices."

In the context of the provided document, the "study" demonstrating the device meets "acceptance criteria" is implicitly the comparison to the predicate device, which is deemed to be safe and effective. The FDA's acceptance is based on this finding of substantial equivalence, not on a new, independently conducted performance study with measurable acceptance criteria.

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