(16 days)
Restorelle polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Restorelle is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Restorelle polypropylene mesh is constructed using a warp-knit process that permits the mesh to be cut into desired shape or size without unraveling. It maintains excellent isotropic properties arising from its knitted construction. Restorelle polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.
The provided text is a 510(k) summary for the Restorelle™ polypropylene mesh and does not contain information about a study that proves the device meets specific acceptance criteria in the manner of a performance study with a test set, ground truth, or human reader evaluations.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) with numerical targets for a device under evaluation. Instead, the "acceptance criteria" appear to be broadly demonstrating that the device is "substantially equivalent" to predicate devices through various technical and material properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility comparable to predicate devices | "The components of the Restorelle device have been subjected to biocompatibility... testing and are substantially equivalent to the predicate Restorelle (K092207) and Minimesh devices (K041632 & K053361)." |
| Mechanical properties (strength, flexibility, durability) | "The device has been subjected to in-vitro testing which demonstrate the ability of the device to adequately permit correct adaptation to the various stresses encountered in the body during normal clinical use." Specifically, "In vitro (bench) tests: Retention, Mechanical, Mass density testing" were conducted. The device "has the necessary strength, flexibility, durability and surgical adaptability properties." |
| Material and manufacturing process (polypropylene mesh, warp-knit) | "Restorelle polypropylene mesh is constructed from knitted monofilaments of extruded polypropylene," similar to the predicate. The "warp-knit process... permits the mesh to be cut into desired shape or size without unraveling." "It maintains excellent isotropic properties arising from its knitted construction." The device has the "same intended use, general design, material and fundamental scientific technology as the predicate Restorelle polypropylene mesh device (K092207)." |
| Sterility | "The device is supplied sterile." (This is a statement of status, not a direct performance outcome from the listed tests, but a requirement for such devices.) |
| Indicated Use | "Restorelle polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route." This is stated to be the "same intended use" as the predicate, therefore demonstrating equivalence. |
Study Details for this 510(k) Submission:
This 510(k) summary describes a submission for substantial equivalence based on non-clinical (bench) testing and comparison to predicate devices, not a clinical performance study involving patient data, ground truth labels, or human reader evaluations in the context of AI/diagnostic device assessment.
Here's why many of the requested items are not applicable or cannot be answered from this document:
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Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the physical mesh samples subjected to in-vitro (bench) mechanical and biocompatibility tests, not a dataset of patient images or clinical cases. The document does not specify the number of samples used for these bench tests, nor does it discuss data provenance in terms of country of origin or retrospective/prospective for clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts in the context of this bench testing for a polypropylene mesh. The "truth" is determined by the physical properties measured in the lab.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no adjudication method described as this is not a diagnostic or AI performance study with expert readers.
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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: Not applicable. This is not a study involving human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical "ground truth." The "ground truth" for the non-clinical tests would be the established physical properties and biocompatibility standards required for medical devices of this type, as demonstrated by the predicate devices.
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The sample size for the training set: Not applicable. There is no AI algorithm being trained.
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How the ground truth for the training set was established: Not applicable.
In summary: This document clearly states, under "Summary Of Clinical Tests Submitted (As Applicable)," that it is "Not applicable." The entire submission is based on non-clinical (in-vitro bench) tests and comparison of technological characteristics to already-approved predicate devices to demonstrate substantial equivalence, rather than a clinical performance study involving patient data or AI algorithm validation.
§ 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.