Search Results

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.

Ask a specific question about this device

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.

This document is a 510(k) summary for a surgical mesh. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The information provided describes the device, its intended use, and states that its technological characteristics and performance are "the same as or equivalent to the predicate device." It also mentions that "Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device." However, no specific details about these tests, the acceptance criteria used, or the results are provided.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document is a high-level summary for regulatory submission, not a detailed study report.

Ask a specific question about this device