(77 days)
The Parietene™M Macroporous Mesh is intended for the repair of hemias or other fascial deficiencies that require the addition of a reinforcing material.
The Parietene™ Macroporous Mesh is a non-absorbable synthetic surgical mesh made out of bi-dimensional monofilament polypropylene textile. The Parietene™ Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal hernias via the anterior approach using a tension free technique.
This submission is for a medical device cleared via a 510(k) pathway, specifically a surgical mesh (Parietene™ Macroporous Mesh). This type of clearance relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria as you might see for a diagnostic AI device or a drug.
Therefore, the input document does not contain the kind of information requested in your prompt regarding acceptance criteria, device performance, study designs, sample sizes, expert ground truth, or MRMC studies. These elements are typically found in submissions for AI/ML-based diagnostic devices or complex medical devices requiring de novo or PMA pathways.
Instead, this 510(k) summary focuses on demonstrating that the new device, Parietene™ Macroporous Mesh, is substantially equivalent to legally marketed predicate devices (PROLENE™ Soft (Polypropylene) Mesh (K001122) and Parietene™ Flat Sheet Mesh (K140941)).
Here's a breakdown of what can be extracted and why other parts of your request are not applicable based on this document:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document does not specify quantitative "acceptance criteria" in the way a diagnostic study would (e.g., target sensitivity, specificity). Instead, the acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device. This is achieved by showing similar technological characteristics and performance.
- Reported Device Performance: The document lists the types of bench tests performed, but does not provide numerical results for either the subject device or the predicate device that would allow for a direct comparison table. It only states that "The bench results demonstrate that the device is substantially equivalent to the predicate PROLENE™ Soft (polypropylene) Mesh (K001122)."
| Characteristic Assessed (Bench Testing) | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (Qualitative) |
|---|---|---|
| Mesh thickness | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Pore size | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Surface density | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Bursting strength | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Bursting distension | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Breaking strength | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Elongation at break | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Tear strength | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Suture strength | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Biocompatibility | Compliance with ISO 10993-1 for a permanent implant | Evaluated in accordance with ISO 10993-1 |
| Shelf-life | Packaging maintains sterility; material stability | Demonstrated by stability results |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. Bench testing for medical devices typically involves specific numbers of samples for each test (e.g., n=5 or n=10 per test), but these details are not disclosed in this high-level 510(k) summary. Data provenance (country of origin, retrospective/prospective) is also not applicable as these are laboratory bench tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. This document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert interpretation for ground truth.
4. Adjudication method for the test set:
- This is not applicable for the same reasons as point 3.
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. This is a physical surgical mesh, not an AI/ML diagnostic device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is a physical surgical mesh, not an algorithm.
7. The type of ground truth used:
- For the bench tests, the "ground truth" would be established by standardized laboratory test methods and measurements (e.g., using calibrated equipment to measure thickness, strength, pore size, etc.). It's not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set:
- This is not applicable. This is a physical surgical mesh, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This is not applicable for the same reasons as point 8.
In summary, the provided document is a 510(k) summary for a surgical mesh, focusing on demonstrating substantial equivalence through bench testing. It does not contain the detailed clinical study data, expert consensus, or AI/ML-specific information requested in your prompt.
§ 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.