(85 days)
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the repair of inguinal and incisional hernias.
Parietex™ Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The nonabsorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Parietex™ Optimized Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable threedimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh: The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The three-dimensional mesh (TET references) has hexagonal pores. The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3-dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a preperitoneal or pre-muscular approach. The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique. The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord. The anatomical mesh is mainly designed for the repair of inguinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side.
Parietex™ Composite Mesh is a composite mesh made out of a three-dimensional (3D) multifilament polyester textile for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin, polyethylene glycol and glycerol and juts out 5 mm over the edge of the reinforcement. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the 3D reinforcement and helps place and fixate the mesh (PCO-OS references).
Parietex™ Optimized Composite Mesh is made out of a three-dimensional (3D) multifilament polyester for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol and juts out 5 mm over the edge of the reinforcement. The film is essentially degraded in less than 1 month. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fixates the mesh (PCO-OSX references). For some references, one or many non-absorbable color monofilaments are tied (pre-placed sutures) to the three-dimensional mesh (PCO-FX references).
This document is a 510(k) summary for a surgical mesh device, which describes its indications for use, device description, comparison to predicate devices, and performance data. However, it does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document describes a medical device clearance based on substantial equivalence to predicate devices, focusing on materials, design, and mechanical performance (bench testing) of surgical mesh. It explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means there was no clinical study, human-in-the-loop study, or AI/ML model performance evaluation described in this document.
§ 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.