(228 days)
Polyform Syntheic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The subject device consists of monofilament polypropylene fibers knitted into a sheet. It is rectangular in shape and available in two sizes, 10 x 15 cm and 15 x 20 cm. Surgeons implanting the subject device cut the mesh to the size and shape needed for an individual patient. The subject device is single use only, supplied sterile, and individually packaged in a Tyvek/Mylar pouch. The subject and predicate device are identical.
This document is a 510(k) premarket notification for a medical device called Polyform™ Synthetic Mesh. It is a letter from the FDA to Boston Scientific Corporation, dated December 15, 2017, confirming that the device has been determined to be substantially equivalent to a legally marketed predicate device.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
Key Takeaway: The submission for the Polyform™ Synthetic Mesh is based on substantial equivalence to a predicate device (K051245), not on a new performance study that establishes design-specific acceptance criteria for the new device. The "modification" for the current submission is an update to the device's Instructions For Use (IFU), and the document explicitly states: "No performance data are needed to support the modifications to the instructions for use."
Therefore, many of the typical questions regarding acceptance criteria and performance studies for a new device's design are not applicable in this 510(k) summary. The acceptance criteria here would primarily relate to the demonstration of identical or highly similar technological characteristics and intended use to the predicate device.
Analysis based on the provided document:
-
A table of acceptance criteria and the reported device performance:
Acceptance Criterion (Implicit for Substantial Equivalence) Reported Device Performance Material Composition: Must be identical or substantially similar to predicate. The subject device consists of "monofilament polypropylene fibers knitted into a sheet," which is implicitly identical or substantially equivalent to the predicate, as the document states "The subject and predicate device are identical." Physical Form/Design: Must be identical or substantially similar to predicate. "It is rectangular in shape and available in two sizes, 10 x 15 cm and 15 x 20 cm." This is implicitly identical or substantially equivalent to the predicate, as the document states "The subject and predicate device are identical." Sterility: Must be supplied sterile. "The subject device is single use only, supplied sterile, and individually packaged in a Tyvek/Mylar pouch." (Implicitly meets standard sterility requirements, consistent with predicate). Intended Use/Indications: Must be identical to predicate. "Polyform Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect."
The document explicitly states: "The subject and predicate device have the same intended use." |
| Technological Characteristics: Must be identical or substantially similar to predicate. | "The subject and predicate device are identical; and accordingly, they have the same technological characteristics." |
| Performance Data: No new performance data needed for the specific modification. | "The Polyform Synthetic Mesh submitted herein is a modification of the predicate mesh device, Polyform Synthetic Mesh (K051245). The modification is an update to the device instructions for use packaged with the product. No performance data are needed to support the modifications to the instructions for use." This explicitly states that no new performance data was required for this specific submission due to the nature of the change (IFU update). The original predicate device's clearance would have been based on its own performance data or substantial equivalence at that time. |
| Predicate Device History: Predicate not subject to design-related recall. | "The predicate device has not been subject to a design related recall." |
-
Sample sizes used for the test set and the data provenance:
- Not Applicable. The submission is not based on a new performance study requiring a test set for design validation. It relies on the substantial equivalence to a predicate device, and the specific modification (IFU update) did not necessitate new performance data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No new test set requiring adjudication was conducted for this 510(k) submission.
-
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 device is a surgical mesh, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (surgical mesh), not an algorithm or software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable for this specific 510(k) submission. The "ground truth" for this submission hinges on the established safety and efficacy of the predicate device, and the demonstration that the subject device is identical to it, with only a change to the Instructions For Use. The original predicate clearance (K051245) would have relied on its own data or prior predicate, which might have included various types of evidence.
-
The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a training set.
-
How the ground truth for the training set was established:
- Not Applicable. (See point 8)
§ 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.