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The ANGIODYNAMICS WorkHorse™ II Percutaneous Transluminal Angioplasty Balloon is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.

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The provided document is a 510(k) clearance letter from the FDA for the WorkHorse™ II Percutaneous Transluminal Angioplasty Balloon Catheter. This type of document does not contain the detailed information about acceptance criteria or a specific study proving the device meets those criteria in the typical format of a scientific study report.

Instead, a 510(k) clearance means the device has been found "substantially equivalent" to a legally marketed predicate device. This equivalence is often demonstrated through a comparison of technological characteristics and performance data (bench testing, some animal studies, or limited clinical data if necessary to address specific performance concerns). The FDA relies on the manufacturer to submit data proving the device is safe and effective for its intended use, typically by showing it performs as well as a predicate device.

Therefore, the specific information requested in your prompt (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for training set) is not present in this FDA clearance letter.

The letter focuses on:

• Acknowledging the 510(k) submission.
• Stating the device is substantially equivalent to predicate devices.
• Providing the regulation number, name, and class.
• Listing the indications for use.
• Reminding the manufacturer of ongoing regulatory compliance requirements.

To obtain the detailed study information you're asking for, one would typically need to review the actual 510(k) submission document itself (which is often voluminous and not publicly released in its entirety), or a summary thereof, rather than just the clearance letter.

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