(81 days)
The Parleten® Palypropylene Meslu is a polypropylene mosh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hermia», parietal reinforcement of tissues and abdominal wall hernia repair.
The Parietene® Polypropylene Mesh is used during open (laparounny) procedures The or during laparoscopic (transperitoneal or preperttoneal) procedures. Parietene® Polypropylene Mesh is offered in several sizes and designs to accommodate the type and approach of the operation as described below:
Parietene® Polypropylene Mesh Models PP 0611, 1510, 1515, 2020, and Parietene® PP 3030 can be used during oven or laparoscopic procedures. Parietence PP 1410, and 1510 are used only during laparoscopic procedures.
All of the models are made from polyethylenc and are available in various sizes.
The Parietene® Polypropylene Mesh are nude from polypropylene sealed monofilament stitches and are offered in square and rectangular shapes with rounded edges. The Parietene® Pulypropylene Mesh are fixed to the patient by either staples or sutures.
The Parietene® Polypropylene Mesh Model 1410 contains a thread made from polyvinyl diffuorene. This thread is used to keep the mesh folded during insertion through a trocar during laparoscopic procedures. The thread is removed when the mesh has been unfolded in the trocar.
Here's an analysis of the provided text regarding the Parietene® Polypropylene Mesh, focusing on acceptance criteria and supporting studies.
Based on the provided K991400 510(k) summary for the Parietene® Polypropylene Mesh, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics against a defined threshold for clinical efficacy.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly defined by the characteristics of the predicate devices. The "reported device performance" are the results of comparative testing demonstrating similarity to these predicates.
| Acceptance Criteria (Implicit from Predicate Devices) | Reported Device Performance (Parietene® Polypropylene Mesh) |
|---|---|
| Intended Use: Reinforcement of tissue during surgical repair for inguinal hernias, parietal reinforcement of tissues, and abdominal wall repair. | Substantially Equivalent Intended Use: "all used for reinforcement of tissue during surgical repair. It is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall repair." (Matches predicate intended uses). |
| Material: Polypropylene scaled monofilament stitches. | Material: "made from polypropylene sealed monofilament stitches" (Similar to Bard-Davol Visilex and Atrium Mesh predicates. Sofradim Parietex is made from polyethylene terephthalate, but the focus for this claim is the polypropylene predicates). |
| Physical Characteristics: Density, thickness, elongation, breaking strength, tear resistance, burst resistance, tensile strength comparable to predicate meshes. | Similar Performance Characteristics: "The test results showed that the Sofradim and predicate devices were similar in performance characteristics" for density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength (tested against Atrium and Visilex Mesh predicates). |
| Configuration: Various sizes and shapes, with options for open or laparoscopic procedures. | Similar Configuration: "various sizes and designs to accommodate the type and approach of the operation," offered in square and rectangular shapes with rounded edges. Some models for open or laparoscopic, others only laparoscopic. Offered with a lateral slit for cord. (Comparable to predicate offerings). |
| Fixation Method: Staples or sutures. | Similar Fixation Method: "fixed to the patient by either staples or sutures." (Matches predicate methods). |
| Sterility: Single-use devices only. | Similar Sterility: "single use devices only." (Matches predicate description). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the number of samples tested for each performance characteristic (density, thickness, etc.). It only states that "Testing was performed."
- Data Provenance:
- Country of Origin: France. "ITF de LYON, a test laboratory in France."
- Retrospective or Prospective: Not explicitly stated, but typically, this type of lab testing for a 510(k) would be conducted specifically for the submission, making it prospective in nature relative to the submission.
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 section is not applicable as the study described is a laboratory performance test of physical material properties, not a clinical study involving human assessment or ground truth determination by experts in a medical context. The "ground truth" here is the measured physical properties of the predicate devices according to ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or image review where multiple human experts interpret data. The described testing is objective laboratory measurement.
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 is not applicable. The submission describes a medical device (surgical mesh), not an AI diagnostic or assistance system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The submission describes a medical device (surgical mesh), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing was the measured physical properties and characteristics of legally marketed predicate devices (Bard-Davol Visilex® Mesh and Atrium Medical Corporation Atrium® Mesh), adhering to ISO standards. The goal was to show that the new device's properties were "similar" to these established devices, not to obtain a definitive "ground truth" of clinical efficacy.
8. The sample size for the training set
This is not applicable. This is a 510(k) submission for a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a physical medical device.
§ 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.