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The Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and or creation of a void in cancellous bone in the spine. This includes use during percutancous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon catheters are designed for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty in association with cleared spinal polymethylmethacrylate (PMMA) bone cements.

The inflation of the balloon serves to create a cavity in the vertebral body, compressing the cancellous bone and/or move cortical bone, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. Winch Kyphoplasty (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyphoplasty procedure.

The low preinflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas. The stiff distal end of the balloon catheter provides rigidity for smooth insertion while flexible proximal catheter allows for easy maneuverability.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for the "Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters."

This document focuses on:

• FDA's substantial equivalence determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Device description and indications for use: Explaining what the device is and what it's intended to do.
• Comparison to predicate devices: Highlighting similarities in technological characteristics.
• Biocompatibility testing: Listing the types of tests performed to ensure the device is biocompatible.
• Performance data (general statement): A general statement that the device "met specifications and performance characteristics" and that "The testing included functional testing" (e.g., dimensional characterization, inflation/deflation time, burst characteristics) and "mechanical testing according to ISO 10555-1:2013".

However, the document does NOT provide:

• A specific table of acceptance criteria.
• Reported device performance against those criteria.
• Details about a formal study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance details, training set information) that would typically prove a medical device meets specific performance acceptance criteria. The performance data mentioned are general functional and mechanical tests to demonstrate equivalence, not a clinical or performance study with detailed statistical outcomes.

Therefore, I cannot fulfill your request based on the provided text.

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