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Occlusion Balloon Catheters are indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.

The Occlusion Balloon Catheter product line consists of two specific designs - Standard Occlusions Balloon Catheters and Berenstein™ Occlusion Balloon Catheter.

Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.

The Occlusion Balloon Catheters are a compliant latex balloon mounted on the distal tip of a dual lumen, radiopaque catheter shaft to which two luer fittings are attached proximally. In addition to the balloon inflation lumen, the central lumen is used to pass the catheter over the guidewire as well as infusion of contrast medium, and in the case of the Berenstein™ Occlusion Balloon Catheter, coaxial delivery of small catheters or embolic agents.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for the provided text. The document describes a medical device, specifically an Occlusion Balloon Catheter, and its 510(k) submission to the FDA. However, the provided text does not contain explicit numerical acceptance criteria or detailed study results that would allow me to construct the specified table and answer all your questions.

The "Performance Data" section and the "Biocompatibility" and "Bench" testing sections generally state that testing was performed and that the results provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It also concludes that the device is "substantially equivalent" to a predicate device.

Key Missing Information:

• Specific, quantifiable acceptance criteria: For example, what was the minimum tensile strength required for the proximal bond, or what was the maximum allowable balloon deflation time?
• Reported device performance values: The document states what tests were done (e.g., "Proximal Bond Tensile"), but not the results (e.g., "Proximal Bond Tensile = X N").
• Sample sizes for test sets (for specific tests): While the tests are listed, the number of units tested for each specific bench test is not provided.
• Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details: These types of information are typically associated with performance studies for AI/ML devices or diagnostic accuracy studies, which are not described in this document for an occlusion balloon catheter. This device appears to be a physical medical instrument, not an AI/ML diagnostic tool.

Therefore, I cannot generate the table or answer questions 2, 3, 4, 5, 6, 7, 8, or 9 as the necessary information is not present in the provided text.

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