Search Results

Parietene™ macroporous mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Parietene™ macroporous mesh is designed for extraperitoneal mesh placement only, for the repair of abdominal wall hernias by laparoscopic or open approach.

Parietene™ macroporous mesh is a non-absorbable synthetic surgical mesh made of two-dimensional (2D) monofilament polypropylene knitted textile.

Parietene™ macroporous mesh is offered in square flat sheet version (50cm x 50cm).

The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The macroporous textile provides strength required to withstand biomechanical stresses throughout the healing period, while allowing for tissue ingrowth. As the textile integrates, host tissue ingrowth is intended to provide strength to the repair.

The detailed composition listed below refers to the estimated maximum amount of each material and substance to which a patient can be exposed when 1 unit of the largest size of Parietene™ macroporous mesh is implanted (i.e. PPM5050). This amount could be less if the mesh is trimmed by the practitioner prior to implantation.

Mesh composition: monofilament polypropylene yarn (up to 11.5 g)

This FDA 510(k) clearance letter is for a surgical mesh (Parietene™ Macroporous Mesh, PPM5050), not an AI-powered diagnostic device. Therefore, the requested information regarding AI device acceptance criteria, study methodologies (MRMC, standalone performance), expert ground truth establishment, training sets, and data provenance is not applicable to this document.

The document discusses the substantial equivalence of the new mesh size (50cm x 50cm) to previously cleared predicate devices based on:

• Performance testing: In-vitro (bench) tests for trocar compatibility, bursting strength, deflection, uniaxial tensile maximum force and elongation, and tear strength.
• Biocompatibility evaluation.
• Sterilization validation.
• Literature and MAUDE database review of predicate and reference devices.

There is no mention of an AI algorithm, human readers, or image interpretation in this clearance.

Ask a specific question about this device

Progrip™ Self-Gripping Polypropylene Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach.

Progrip™ self-gripping polypropylene mesh is a sterile non-pyrogenic device made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side.

Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.

The non-absorbable textile is designed to ensure long term reinforcement of soft tissues.

The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.

Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial envelope with the Instructions for Use (IFU) and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial envelope (single pack configuration: 1 unit per commercial envelope).

The provided text is a 510(k) summary for the Progrip™ Self-Gripping Polypropylene Mesh (K232373). It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document discusses various performance tests conducted (sterilization, shelf-life, shipping, biocompatibility, in vitro bench tests) to demonstrate substantial equivalence to the predicate device. However, these are presented as evaluations against established standards and guidance documents, rather than against specific, numerical acceptance criteria for a new clinical study.

Furthermore, the document explicitly states: "This premarket submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This indicates that no clinical study was performed for this 510(k) submission.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this type of data is not present in the provided text. The submission relies on non-clinical performance and a comparison to predicate devices to establish substantial equivalence.

Ask a specific question about this device