FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Pre-cut, elliptic mesh with slit and self-gripping, overlapping flap. Right or left anatomical side.
Rectangular mesh.
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
The subject modified ProGrip™ self-gripping polypropylene mesh is different from the predicate ProGrip™ self-gripping polypropylene mesh (K140941) in labeling and new sterilizer facilities with the same ethylene oxide method. There is no change to the technology, engineering, or material specifications.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "ProGrip Self-Gripping Polypropylene Mesh." The purpose of this submission is to demonstrate that the revised device is substantially equivalent to a legally marketed predicate device (K140941). The primary changes described are related to labeling updates and the addition of new sterilization facilities using the same ethylene oxide (EO) method.

Given this context, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/algorithm performance (e.g., impact on human readers, standalone performance, ground truth establishment, training set details) is not applicable to this specific submission.

Here's why, and what information can be extracted relevant to the submission:

Key Takeaway: This is a 510(k) for a physical medical device (surgical mesh), not an AI/Software as a Medical Device (SaMD). The "studies" conducted are non-clinical validations related to manufacturing processes, not diagnostic algorithm performance.

Therefore, I cannot provide the requested information for AI/algorithm performance. However, I can explain the acceptance criteria and supporting "studies" (validations) for this physical device:

Acceptance Criteria and Supporting Studies for ProGrip Self-Gripping Polypropylene Mesh (K220540)

This 510(k) submission primarily focuses on demonstrating that the changes made to the ProGrip Self-Gripping Polypropylene Mesh (labeling and new sterilization facilities) do not alter its substantial equivalence to the predicate device (K140941) regarding safety and effectiveness. The "acceptance criteria" here relate to maintaining established standards for sterilization, aeration, biocompatibility, and product performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance / Validation Outcome
Sterilization	Reliable and consistent sterilization to achieve the same Sterility Assurance Level (SAL) as the predicate device.	Validation studies demonstrated that the sterilization processes at new sites are capable of reliably and consistently sterilizing the product, achieving the same SAL as K140941.
Aeration (EtO Residuals)	Ethylene Oxide (EtO) residual levels must comply with allowable limits: ≤ 4mg/device, per ISO 10993-7.	EtO residual evaluation was conducted (ISO 10993-7 compliant). ProGrip™ Self-Gripping Polypropylene Mesh complies with the allowable limits of EtO residual: ≤ 4mg/device. The new sterilizers use a dynamic aeration process.
Biocompatibility	Biological safety must be compliant with ISO 10993-1, with no negative impact from new sterilization facilities.	Existing biocompatibility assessments remain applicable as there is no material or manufacturing change. Compliance with ISO 10993-1 for biological safety was found. The new sterilization facilities have no biocompatibility impact.
Stability	No adverse impact on device stability due to minor differences in sterilization parameters or changes to packaging integrity.	Minor differences in sterilization parameters have been shown to have no impact on the stability of the device. Packaging sealing and overall packaging integrity remain unchanged.
Product Performance	Device performance remains unchanged despite new sterilization facilities.	Product performance remains unchanged as there are no changes to the design or materials. New sterilizers maintain the same sterilization method and SAL.
Indications for Use (IFU)	Updated IFU aligns with global IFU and does not significantly affect safety and effectiveness compared to the predicate device.	The IFU was updated to "Inguinal hernia repair via anterior tension-free approach." This is considered an insignificant change to limit use that does not significantly affect safety and effectiveness.
Materials/Design	No changes to raw materials or design that would impact safety or effectiveness.	Stated that the device description is "identical to the predicate," "no design change," "no change to the technology, engineering, or material specifications."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as "sample size" in the context of a test set for diagnostic performance. Instead, validation studies were performed on product batches from the new sterilization sites. The specific number of units tested for sterilization, EtO residuals, and stability would be detailed in the underlying validation reports, but this summary document does not provide those specific numbers.
Data Provenance: The data comes from internal validation studies conducted by Covidien/Medtronic, related to their manufacturing processes and new sterilization facilities. The location of these new facilities is not specified (e.g., country), but the general context is a US FDA submission. The studies are by nature prospective validations of the manufacturing and sterilization processes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is not an AI/diagnostic device. "Ground truth" in this context would relate to established standards (e.g., ISO for sterilization, biocompatibility, EtO residuals) and the qualifications of the engineers/scientists conducting the validation tests, not expert readers.

4. Adjudication method for the test set

Not Applicable. This is not an AI/diagnostic device where adjudication of diagnostic outputs by multiple experts is relevant. Compliance with standards is demonstrated through test results.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

Not Applicable. This is not an AI/diagnostic device, so MRMC studies comparing human reader performance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical surgical mesh, not an algorithm.

7. The type of ground truth used

Regulatory/Engineering Standards: The "ground truth" for this submission is adherence to established regulatory and engineering standards (e.g., ISO 10993-1 for biocompatibility, ISO 10993-7 for EtO residuals), and internal quality system validation protocols for sterilization and product performance. The predicate device (K140941) also serves as a benchmark for equivalence.

8. The sample size for the training set

Not Applicable. This is a physical surgical mesh, not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable. See #8.

In summary, the provided document is a regulatory submission for a physical medical device. The "acceptance criteria" and "studies" it references are related to demonstrating the continued safety and effectiveness of the device despite manufacturing and labeling changes, primarily through non-clinical validation testing against established industry and regulatory standards.

Summary

Regulation Number and Section

§ 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.