(87 days)
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.