(19 days)
For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
Biocompatible, expanded polytetrafluoroethylene (ePTFE) with a removable, tinted silicone component (DualMesh® EMERGE Biomaterial). Biocompatible, ePTFE loaded with antimicrobial preservative agents chlorhexidine diacetate and silver carbonate with a removable, tinted silicone component (DualMesh® EMERGE PLUS Biomaterial). Both devices have one open microstructure surface and one closed microstructure surface. The open microstructure surface is textured with a "ridges and valleys" pattern to aid in surface identification and proper surface orientation.
The provided text is a 510(k) Premarket Notification summary for the DualMesh® EMERGE Biomaterial and DualMesh® EMERGE PLUS Biomaterial. This submission describes a modification to an existing, currently marketed device and claims substantial equivalence to a predicate device.
For such a submission, the "acceptance criteria" and "device performance" are typically framed in terms of demonstrating that the modified device performs equivalently to the predicate device and that the modification does not raise new questions of safety or effectiveness. The studies performed are primarily designed to establish this equivalence, not to establish novel performance metrics against pre-defined clinical acceptance criteria like those seen for entirely new devices or AI software.
Therefore, the table below reflects the equivalence claims as the "acceptance criteria" and the "reported device performance" as confirmation of that equivalence through various tests.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Equivalence Claims) | Reported Device Performance |
|---|---|
| Mechanical Strength & Material Characterization: Applicant devices are substantially equivalent to predicate devices. | Bench test data reveal the applicant devices have mechanical strength and material characterization values that are substantially equivalent to the predicate devices. |
| Antimicrobial Activity (PLUS version): Applicant device functions safely and effectively to inhibit bacterial colonization for up to ten days post-implantation, equivalent to the predicate. | In-vitro antimicrobial activity test data demonstrate that the antimicrobial version of the applicant device functions both safely and effectively to inhibit bacterial colonization of the device for up to ten days post-implantation. (Also stated: "perform an equivalent preservative function"). |
| Tissue Response: Tissue response for applicant devices is equivalent to histological controls for the predicate devices. | In-vivo animal test data document that the tissue response for the applicant devices is equivalent to histological controls for the predicate devices. |
| Biocompatibility: No change from predicate device. | The biocompatibility for the applicant devices has not changed from those for the predicate device. |
| Packaging & Sterilization: No change from predicate device. | The packaging and sterilization process for the applicant devices have not changed from those for the predicate device. |
| Intended Use & Indications: No change from predicate device. | These changes do not change the device's intended use or indications. |
| Overall Safety & Effectiveness: Modification does not raise new questions of safety or effectiveness. | The modification described in this Premarket Notification does not raise questions of safety or effectiveness that have not been previously addressed. Both the applicant devices and the predicate devices perform their equivalent clinical functions by incorporating biocompatible materials to permanently or transiently bridge or support a tissue defect. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the bench tests, in-vitro antimicrobial activity tests, or in-vivo animal tests. It only states that these tests were performed and their results. The data provenance is not explicitly mentioned (e.g., country of origin), but it can be inferred that these studies were conducted to support a US FDA 510(k) submission. These studies would be considered prospective in nature, as they were conducted specifically for this submission to evaluate the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. "Ground truth" in the context of expert consensus, as typically discussed for AI devices in diagnostics, is not relevant here. The studies involve laboratory measurements (mechanical properties, antimicrobial activity) and animal histological assessments, where "ground truth" is derived from established scientific methods and benchmarked against the predicate device. The experts involved would be those conducting these specialized tests (e.g., mechanical engineers, microbiologists, veterinary pathologists), but their number and specific qualifications are not detailed.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. The bench and animal studies described here do not involve such a process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. An MRMC comparative effectiveness study is not applicable and was not done for this device. MRMC studies are typically used for diagnostic devices, especially those incorporating AI, to assess the impact of the device on human reader performance. This submission concerns a surgical mesh biomaterial, a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and was not done. This device is a biomaterial, not an algorithm or AI software for which standalone performance would be assessed.
7. The type of ground truth used
The "ground truth" for the various tests can be categorized as:
- Bench Test Data: Derived from standardized testing protocols and measurements of physical and material properties, often compared directly to specifications or predicate device values.
- In-vitro Antimicrobial Activity: Established through laboratory microbiological assays demonstrating inhibition of bacterial growth.
- In-vivo Animal Test Data: Established through histological examination of animal tissues, assessed by veterinary pathologists, and compared to the tissue response observed with the predicate device.
8. The sample size for the training set
This information is not applicable and not provided. The concept of a "training set" is relevant to machine learning and AI, which are not involved in the development or evaluation of this biomaterial device.
9. How the ground truth for the training set was established
This information is not applicable. As no "training set" in the AI/ML sense was used, no ground truth needed to be established for it.
§ 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.