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For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

(Trade name) is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.

The provided text does not contain the acceptance criteria or information about a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a surgical mesh, focusing on its substantial equivalence to predicate devices. It discusses:

• Device Name: Brennen Biosynthetic Surgical Mesh Matrix
• Indication for Use: Treatment of hernias and as a sling material for female urinary incontinence.
• Device Description: Sterile, processed, and treated porcine skin.
• Technological Characteristics and Performance: States that "The technological characteristics are the same or equivalent to the predicate device. Testing and review of the literature has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device."

Missing Information:
The document does not provide any specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either training or test sets. It merely asserts that "testing and review of the literature" was done to demonstrate substantial equivalence, but offers no specifics about these tests.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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