(192 days)
The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.
The proposed Phasix™ ST Mesh is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh prosthesis designed for the reinforcement and reconstruction of soft tissue deficiencies. Phasix ™ ST Mesh is co-knitted using poly-4-hydroxybuterate (P4HB) and polyglycolic acid (PGA) fibers. P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months indicates loss in mechanical integrity and strength. While fiber segments were observed at 18 months, they continued to degrade. Phasix ™ ST Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
This document is a 510(k) premarket notification for the Phasix™ ST Mesh, a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies. Therefore, the information typically requested in your prompt (acceptance criteria, specific study designs, sample sizes for training/test sets, ground truth establishment for AI/algorithm-based devices, MRMC studies, etc.) is not present in this document, as it pertains more to software or diagnostic device submissions.
However, I can extract the information provided regarding performance data relevant to establishing substantial equivalence.
Here's a summary of the performance data reported:
1. A table of acceptance criteria and the reported device performance
- This document does not provide a table of acceptance criteria with specific numerical targets and reported performance values. Instead, it lists the types of tests performed to demonstrate substantial equivalence, implying that the results of these tests were deemed acceptable by the FDA for the purpose of 510(k) clearance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes pre-clinical (biocompatibility, bench, and animal) studies, not human clinical trials. Sample sizes for these studies are not specified in this summary. Data provenance (country of origin, retrospective/prospective) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth establishment by experts is typically relevant for diagnostic devices or AI algorithms. This document concerns a surgical mesh.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for studies involving human interpretation, often in diagnostic contexts.
5. 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. MRMC studies are used for evaluating diagnostic performance, particularly of AI-assisted systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of an AI/diagnostic device. For the animal studies, the "ground truth" would be established by direct observation and analysis of the implanted mesh and surrounding tissues, likely involving histology/pathology conducted by veterinarians and researchers.
8. The sample size for the training set
- Not applicable. This device is a physical surgical mesh, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical surgical mesh, not an algorithm that requires a training set.
Summary of Performance Data (as provided in the document for K143380):
The performance data provided supports the substantial equivalence determination for the Phasix™ ST Mesh. The general approach was to compare the new device to existing predicate devices (TephaFLEX® Mesh and Ventralight™ ST Mesh) that are already legally marketed.
| Category | Tests Performed | Equivalence/Outcome |
|---|---|---|
| Biocompatibility | - Cytotoxicity |
- Genotoxicity
- Sensitization
- Intracutaneous Reactivity
- Local and Systemic Toxicity (4 and 13 week)
- Local Toxicity (4, 8, 13, and 20 week)
- Systemic Toxicity (Acute)
- Pyrogenicity | Demonstrated that the materials (P4HB, PGA, hydrogel coating) are biocompatible, addressing risks associated with component interactions, in accordance with FDA guidance (Blue Book Memorandum #G95-1 and ISO-10993). Implies results met acceptance criteria for biocompatibility. |
| Electrical Safety / EMC | None required | Not applicable as the device has no electrical or metal components. |
| Software V&V Testing | None required | Not applicable as the device does not contain software. |
| Bench Testing | - Mesh weave characteristics - Device stiffness
- Mesh pore size
- Burst strength
- Mesh density
- Tear resistance
- Mesh thickness
- Suture pullout strength
- In vitro degradation study | Performed to compare the proposed Phasix™ ST Mesh to the predicate TephaFlex® Mesh and Ventralight™ ST Mesh.
The in-vitro degradation study demonstrated that PGA fibers and hydrogel coating do not impact the resorption profile of the P4HB mesh.
Implies results demonstrate substantial equivalence for physical and performance characteristics per FDA guidance for surgical mesh. |
| Animal Studies | In vivo porcine studies at 4, 12, and 24 weeks | Characterized mechanical strength, tissue response, and resorption profile in comparison to predicate devices. The implication is that these studies showed comparable performance to the predicates. |
| Clinical Study | None required | No clinical study was required to support the 510(k) clearance for Phasix™ ST Mesh, indicating that the preclinical data (biocompatibility, bench, and animal studies) were sufficient to establish substantial equivalence. |
Conclusion:
The document states that "All test results provided in this submission demonstrate that the proposed Phasix™ ST Mesh is substantially equivalent to the cited TephaFlex® Mesh and Ventralight™ ST Mesh predicates." This means the conducted tests (biocompatibility, bench, and animal studies) produced results that satisfied the FDA's requirements for demonstrating that the device is as safe and effective as the predicate devices, despite minor technological differences.
§ 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.