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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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Is for the "repair of hemias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result."

ULTRAPRO* Mesh is a sterile partially absorbable composite mesh designed for the repair of hernias and other abdominal fascia deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non absorbable polypropylene monofilament fiber.

The provided text describes the ULTRAPRO* Mesh device, a sterile, partially absorbable composite mesh for repairing hernias and other abdominal fascia deficiencies. The document is a 510(k) summary for the device, seeking substantial equivalence to predicate devices.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a separate "test set" in the context of a clinical study with human patients. The performance data section mentions "Non-clinical laboratory testing" and "animal testing." No details on the sample sizes for these tests (e.g., number of animals, number of mesh samples for lab tests) are provided, nor is the country of origin of the data mentioned. The data is non-clinical and animal-based, not involving human patients in a retrospective or prospective manner as would be typical for medical device performance studies involving patient outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The study presented is a non-clinical and animal study, not a human clinical trial where expert consensus on "ground truth" for patient outcomes would typically be established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As noted above, there is no human "test set" or clinical trial described that would necessitate an adjudication method for establishing ground truth from multiple expert readings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This device is a surgical mesh, not a diagnostic or AI-powered device that involves human "readers" or an AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study was not done. This device is a physical surgical mesh, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical laboratory testing, the "ground truth" would be objective measurements against established engineering and material science standards for surgical meshes.

For the animal testing, the "ground truth" regarding "good tissue ingrowth" would likely be based on histological examination and macroscopic assessment by veterinary pathologists or other trained professionals, comparing the tissue response to existing accepted benchmarks for similar devices. This is a form of biological outcome data.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical surgical mesh, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

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