(39 days)
Parietex™ lightweight mesh is indicated for inguinal and ventral hernia repair.
The PARIETEX™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
The Parietex™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists in procedures involving primary abdominal wall and incisional hernia surgeries. The non-absorbable 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™ Lightweight Mesh: Non-absorbable synthetic surgical mesh made of two-dimensional monofilament polyester knitting.
Parietex™ Composite Parastomal Mesh: PARIETEX™ Parastomal Mesh is made from a monofilament polyester fabric, covered with an absorbable hydrophilic film. The meshes are available in two different designs. Both are round in shape. The first design is made from a three-dimensional monofilament polyester fabric and has a circular opening in the center. It is completely covered on one side with an absorbable hydrophilic film made of collagen from porcine origin, polyethylene glycol and glycerol. The second design is made from a three dimensional monofilament polyester fabric with a twodimensional monofilament polyester central band. One side of the second design is completely covered with the hydrophilic film. On the opposite side, only the two dimensional central band is coated with the absorbable hydrophilic film. On both designs the film extends 5 mm over the external edge of the reinforcement, and also extends around the internal edge of the circular opening if any.
Parietex™ Composite Ventral Patch: The Parietex™ composite ventral patch is a dual facing mesh composed of a non-absorbable three dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four (4) flaps made out of monofilament polyester textile and two (2) removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with absorbable poly(divcolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh. The fascial side of the mesh ensures abdominal wall reinforcement allowing complete tissue ingrowth. The visceral side of the mesh is composed of porcine origin collagen film, polyethylene glycol and glycerol. This film is absorbable, continuous and hydrophilic and juts out over the edge of the textile. This side physically separates the polyester textile from tissues and organs to minimize tissue attachment to the mesh in case of direct contact with viscera. The four (4) flaps of the Parietex™ composite ventral patch which provide a dedicated fixation surface area are composed of a dyed (D&C Green no. 6) bidimensional monofilament polyester textile. These flaps also facilitate visualization during the semi-peripheral suture fixation. Two (2) dyed (D&C Violet no. 2) PGLA expanders provide shape memory to the mesh and offer stability to facilitate insertion and proper deployment of the mesh through defect. The PGLA component is completely absorbed prior to one (1) year. The device also presents two (2) removable handles (composed of colored tubes and yarns) that are attached to the extremity of the flaps to provide a means for proper positioning of the mesh. They are kept extra corporally during the procedure and discarded after the surgery. The PGLA component and the hydrophilic film are fully absorbable which provide less long term foreign material in the body.
Symbotex™ Composite Mesh: Symbotex™ composite mesh is made out of a three-dimensional monofilament polyester textile, which is 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. The collagen film is essentially degraded in less than 1 month. For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "Flat Sheet with sutures" (SYM-F reorder codes): Non-absorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fix the mesh.
The provided document is a 510(k) summary for several surgical mesh products, indicating very limited information regarding acceptance criteria and detailed study results typical of clinical performance studies of AI/ML devices. The document focuses on demonstrating substantial equivalence to predicate devices primarily through bench testing, stability studies, and biocompatibility studies, rather than clinical performance or AI algorithm validation.
Here's a breakdown of the requested information based on the document, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a quantitative table with reported device performance for clinical endpoints. Instead, it refers to general performance characteristics and equivalence to predicate devices based on:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Bench Testing (in accordance with FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999) | "Bench testing has been conducted... to evaluate the performance characteristics of proposed devices." (The specific performance characteristics tested and their results/acceptance thresholds are not detailed in this summary.) The conclusion states that bench testing results "demonstrate that proposed devices are substantially equivalent to the predicates." This implies the new material met the performance standards of the predicate devices. |
| Stability | "Stability Studies have been conducted and the proposed devices shelf life has been demonstrated." (Specific duration and measures of stability are not provided.) |
| Biocompatibility (in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156)) | "Biocompatibility studies have been conducted on the proposed polyester based devices..." The conclusion states that preclinical test results "demonstrate that proposed devices are substantially equivalent to the predicates." This implies the new material met the biocompatibility standards required for a permanent implant as per ISO 10993-1. |
| Equivalence in Technological Characteristics | The proposed devices are stated to be equivalent to predicate devices in terms of: Indigenous, Raw materials, Performance characteristics, Biocompatibility, Stability, and Design. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not provided in the document. The studies referenced are bench testing, stability studies, and biocompatibility studies, which typically involve material samples or animal models, not human test sets in the context of clinical performance for AI/ML.
- Data Provenance: This information is not provided. The studies are technical in nature (bench, stability, biocompatibility).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided. The assessment for these surgical meshes relies on physical and biological testing, not on expert adjudication of diagnostic images or clinical assessments to establish ground truth for an AI/ML algorithm.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic AI/ML. This document describes material science and biological compatibility testing.
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
This information is not applicable/not provided. MRMC studies are relevant for evaluating diagnostic or assistive AI systems. The subject of this 510(k) is a surgical mesh with a change in raw material, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used
For the studies mentioned:
- Bench Testing: Ground truth is established by standardized measurements and tests of physical properties of the mesh following established FDA guidance for surgical mesh.
- Stability Studies: Ground truth relates to maintaining specified physical and chemical properties over time, measured through established analytical methods.
- Biocompatibility Studies: Ground truth is established by adherence to ISO 10993-1 standards, which involves evaluating biological responses to the material (e.g., cytotoxicity, irritation, sensitization, systemic toxicity), often using in vitro or in vivo (animal) models. They are not based on expert consensus, pathology in the clinical diagnostic sense, or patient outcomes data in this context for "ground truth".
8. The sample size for the training set
This information is not applicable/not provided. The document describes a material change for a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, there is no AI/ML algorithm with a training set.
§ 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.