(86 days)
VYPRO Mesh is indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
VYPRO Mesh is constructed from approximately equal parts of absorbable polyglactin 910 multifilament fiber and non-absorbable polypropylene multifilament fiber. The purpose of the absorbable polyglactin component is to add firmness to the polypropylene structure and thus make intraoperative handling of the mesh easier. The mesh affords excellent strength, durability and surgical adaptability, with a porous structure to enable mesh incorporation into surrounding tissues. The polymer of the polypropylene fiber is identical to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
The polyglactin fiber consists of a copolymer containing 90% glycolide and 10% lactide. This copolymer is identical in composition to that which has been found to be nonantigenic, nonpyrogenic and to elicit only a mild tissue reaction during absorption. The polyglactin component is absorbed within 56 to 70 days, leaving the polypropylene mesh structure that is able to withstand the physiological stresses to which the abdominal wall is subject.
The provided document describes the predicate device information for the K002672 submission for VYPRO Mesh. It is not a study proving the device meets acceptance criteria but rather a declaration of substantial equivalence to predicate devices based on technological characteristics and a clinical study. Therefore, most of the requested information regarding acceptance criteria and study particulars cannot be fully extracted.
Here's what can be inferred from the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative table format with corresponding performance metrics that the device had to pass. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices (PROLENE Mesh, VICRYL Mesh, and MERSILENE Mesh) based on technological characteristics and a clinical comparison.
The "Performance Data" section indicates that certain characteristics were evaluated and compared to predicate devices:
| Characteristic | VYPRO Mesh Performance (vs. Predicate Devices) |
|---|---|
| Thickness | Less than PROLENE Mesh, but greater than MERSILENE Mesh |
| Burst Strength | Less than PROLENE Mesh, but greater than MERSILENE Mesh; higher burst strength than MERSILENE Mesh |
| Flexural Rigidity | Less than PROLENE Mesh, but greater than MERSILENE Mesh |
| Tear Strength | Less than PROLENE Mesh, but greater than MERSILENE Mesh |
| Suture Pull-out | Less than PROLENE Mesh, but greater than MERSILENE Mesh |
| Tensile Strength | Less than PROLENE Mesh, but greater than MERSILENE Mesh |
| Pore Size | Larger pore size than PROLENE Mesh |
| Absorbable Component | Absorbable polyglactin component is absorbed within 56 to 70 days |
Note: The phrasing "less than PROLENE Mesh, but greater than MERSILENE Mesh" appears to be a general comparison across all mechanical properties listed, followed by specific comparisons for burst strength and pore size. The document doesn't provide specific numerical values for these characteristics.
Study Information (as inferable from the document)
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Sample size used for the test set and the data provenance:
- The document mentions "The results of a clinical study compared the use of VYPRO Mesh with MARLEX and ATRIUM Meshes." However, it does not provide the sample size for this clinical study.
- Data Provenance: Not specified (e.g., country of origin). The document only states "clinical study."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document, as it's a 510(k) summary focused on substantial equivalence rather than a detailed clinical trial report.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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:
- No, an MRMC study was not done. This device is a surgical mesh, not an AI diagnostic tool. The "clinical study" mentioned was a comparison of surgical mesh performance, not a reading task.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is a physical medical device (surgical mesh), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document states the clinical study "found VYPRO Mesh to be acceptable with regard to mechanical and therapeutic characteristics including some advantages in bench testing and clinical trials." This implies that clinical outcomes and possibly mechanical evaluations in a clinical setting served as the basis for "acceptability." Specific details on how ground truth was established (e.g., specific clinical endpoints, pathology confirmation, expert assessment of outcomes) are not provided.
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The sample size for the training set:
- This information is not applicable as this is not an AI/ML device that requires a training set. If referring to experience with predicate devices or materials, it's not quantified in terms of a "training set."
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How the ground truth for the training set was established:
- This information is not applicable as this is not an AI/ML 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.