(225 days)
Parietene™ DS Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the repair of ventral hernias or other abdominal fascial deficiencies that require the addition of a reinforcing material.
Parietene™ DS Composite Mesh is designed to be placed in an intraperitoneal site by a laparoscopic or open approach. The mesh is composed of a permanent macroporous polypropylene textile on one side and a fully absorbable synthetic film on the other side. The film is adhered to the textile using a binding agent localized on the textile fibers. A violet marking is positioned on the mesh to help center and orient the mesh. Non-absorbable preplaced sutures are tied to the mesh.
-The macroporous textile is knitted from a permanent monofilament polypropylene yarn.
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The synthetic film is made out of absorbable synthetic copolymer of glycolide, caprolactone, trimethylene carbonate, and lactide.
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The binding agent and the violet marking are made out of absorbable polycaprolactone. The D&C Violet No. 2 dye is used for the marking.
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The pre-placed sutures are made out of an isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin) and polyethylene. The Copper Phthalocyanine Blue is used to color the sutures.
The permanent macroporous textile is designed to be placed over the abdominal wall to ensure long term reinforcement of soft tissues, while the continuous absorbable film is designed to minimize tissue attachment to the mesh in case of direct contact with the viscera and is essentially degraded within 105 days by hydrolysis.
This document is a 510(k) premarket notification for the "Parietene™ DS Composite Mesh," a surgical mesh device. The available information does not include a description of acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML powered device, which your request implies. The device in question is a physical surgical mesh, and its evaluation is based on bench testing of physical properties, animal studies, and biocompatibility, not on AI/ML performance.
Therefore, many of the requested categories are not applicable to the provided document. I will fill in the applicable information based on the document's content.
Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for each performance characteristic in the form of a pass/fail threshold. Instead, it states that in vitro tests were "performed in accordance with the 'Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh'" and conducted "in comparison with the predicate Proceed™ Surgical Mesh (K060713)." The implicit acceptance criterion is that the subject device's performance profiles are comparable to, or within acceptable limits of, the predicate device. Specific numerical results or "reported device performance" values are not provided in this summary, only the types of tests performed.
| Characteristic Tested (Acceptance Criteria Implicitly: Comparable to Predicate Device) | Reported Device Performance (Specifics Not Provided in Document) |
|---|---|
| Pore size | Not specified beyond "comparable to predicate" |
| Thickness | Not specified beyond "comparable to predicate" |
| Surface density | Not specified beyond "comparable to predicate" |
| Bursting strength | Not specified beyond "comparable to predicate" |
| Bursting distension | Not specified beyond "comparable to predicate" |
| Breaking strength | Not specified beyond "comparable to predicate" |
| Elongation at break | Not specified beyond "comparable to predicate" |
| Tear strength | Not specified beyond "comparable to predicate" |
| Suture pull-out strength | Not specified beyond "conformity to USP monograph for non-absorbable surgical suture" and "assess the strength of the textile/suture assembly" |
| Knot-pull tensile strength | Not specified beyond "conformity to USP monograph for non-absorbable surgical suture" and "assess the strength of the textile/suture assembly" |
| Trocar passage integrity | "demonstrate that the integrity of the mesh is preserved" |
| Tissue integration (in vivo) | "evaluate the tissue integration" (comparable to predicate) |
| Minimizing tissue attachment (in vivo) | "demonstrate the minimizing tissue attachment performance" (comparable to predicate) |
| Stability/Shelf life | "demonstrated" |
| Biocompatibility | "compliant with ISO Standard 10993-1" |
| Usability | "demonstrate that the subject Parietene™ DS Composite Mesh is safe and effective" |
1. Sample sizes used for the test set and the data provenance:
- Test set sample sizes: Not specified in the document for any of the in vitro, in vivo, or usability tests.
- Data provenance:
- In vitro (bench) tests: Performed in accordance with FDA guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" (1999).
- In vivo pre-clinical tests: Conducted on "representative animal models." Specific country of origin for the animal studies is not mentioned, and they are prospective in nature for a pre-clinical evaluation.
- Biocompatibility tests: Compliant with ISO Standard 10993-1.
- Stability study: Conducted.
- Usability tests: Conducted.
The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This implies a lack of human clinical trial data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical surgical mesh, not an AI/ML powered device requiring a "ground truth" established by experts in the context of diagnostic interpretation. The evaluation relies on standardized physical tests, animal studies, and regulatory standards.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of expert adjudication as this is not a diagnostic device.
4. 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:
- Not applicable. This is not an AI/ML powered device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML powered device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by:
- Compliance with recognized standards (e.g., USP monograph for sutures, ISO 10993-1 for biocompatibility).
- Comparability to a legally marketed predicate device (Proceed™ Surgical Mesh K060713) based on established in vitro and in vivo test methods commonly used for surgical meshes.
7. The sample size for the training set:
- Not applicable. This is not an AI/ML powered device, so there is no "training set."
8. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML powered 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.