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ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

ULTRAPRO ADVANCED™M Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

ULTRAPRO™ Mesh is manufactured from approximately equal parts* of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber. The polymer of the undyed and dyed polypropylene fiber (phthalocyanine blue, Color Index No .: 74160) is identical to the material used for dyed/undyed PROLENE™ suture material. Poliglecaprone-25 fiber consists of a copolymer containing glycolide and &-caprolactone; this copolymer is identical to the material used for MONOCRYL™ suture. After absorption of the poliglecaprone-25 component, only the polypropylene mesh remains. The structure and size of this remaining mesh are optimally designed for the physiological stresses of the abdominal wall.

ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh is a sterile, partially absorbable mesh*, designed for the repair of abdominal wall hernias and other abdominal wall deficiencies. The device is manufactured out of dyed (phtalocyanine blue) and undyed nonabsorbable polypropylene monofilaments (3.5 mil PROLENE™) as well as a twist, composed of dyed (phtalocyanine blue) and undyed non-absorbable polypropylene monofilaments (3.5 mil PROLENE™) and undyed absorbable poliglecaprone 25 monofilaments (5 mil MONOCRYL™). Blue stripes provide orientation.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Ethicon Inc. regarding ULTRAPRO™ Mesh and ULTRAPRO ADVANCED™ for surgical mesh.

It primarily focuses on:

• FDA's determination of substantial equivalence to previously marketed predicate devices (ULTRAPRO™ Mesh K033337 and ULTRAPRO ADVANCED K150906).
• Device description: detailing the materials and composition of the mesh.
• Indications for Use: for the repair of abdominal wall hernias and deficiencies.
• Summary of Technological Characteristics: stating that the subject devices are identical to the predicate devices in terms of technology, materials, construction, manufacturing, and sterilization, with only labeling changes for clarity and regulatory expectations.
• Conclusion: affirming substantial equivalence based on identical intended use and technological characteristics to the predicate devices.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Details of any study conducted to demonstrate the device meets acceptance criteria.
• Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC, standalone algorithm performance).

Therefore, I cannot fulfill your request to describe acceptance criteria and a corresponding study based on the provided text.

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