(183 days)
The Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. or for use in procedures involving soft tissue repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
The proposed Phasix™ Mesh utilizes a fully resorbable poly-4-hydroxybutyrate (P4HB) polymer material. The P4HB is produced from a naturally occurring monomer and is processed into monofilament fiber then knitted into a surgical mesh. The Phasix™ Mesh is packaged individually as a sterile, single flat mesh available in several rectangular sizes and one small circle. Phasix™ Mesh provides immediate short term support and provides a scaffold that enables tissue in-growth over time while the mesh predictably and gradually degrades via hydrolysis and a hydrolytic enzymatic digestive process. Preclinical implantation studies indicate that Phasix™ Mesh retains approximately 70% of its strength at 12 weeks. Absorption of the mesh material will be essentially complete within 12 to 18 months.
This document describes the premarket notification for the Phasix™ Mesh, a surgical mesh, and its comparison to a predicate device, the TephaFLEX® Mesh. The submission focuses on demonstrating substantial equivalence rather than presenting an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this document.
Here's an attempt to answer the questions based on the provided text, noting where information is not available due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Phasix™ Mesh) |
|---|---|
| Mesh weave characteristics comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Mesh pore size comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Mesh density comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Mesh thickness comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Device stiffness comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Burst strength comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Tear resistance comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Suture pullout strength comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Cytotoxicity met acceptance criteria | Passing results |
| Biocompatibility (Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity, Chronic Toxicity, Implantation, Haemocompatibility) met acceptance criteria | All met acceptance criteria (leveraged from predicate) |
| Resorption profile (retains approx. 70% strength at 12 weeks, complete within 12-18 months) | Same as predicate TephaFLEX® Mesh (leveraged from predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The document does not specify the exact sample sizes for each bench test. It states "Bench testing was performed to compare the proposed Phasix™ Mesh to the predicate TephaFLEX® Mesh."
- Biocompatibility/Animal Studies: The data was largely leveraged from the predicate device (TephaFLEX® Mesh), which was FDA cleared. Specific sample sizes for these studies are not detailed in this document. The provenance is implied through FDA clearance and adherence to international and FDA guidance documents. These were likely prospective studies conducted for the predicate.
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)
This is not applicable as the device is a surgical mesh, not an AI/ML diagnostic tool. Ground truth in this context would refer to objective material properties and biological responses, measured through standardized tests, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the device is a surgical mesh and no expert adjudication for a test set is mentioned or relevant to its evaluation for substantial equivalence.
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
This is not applicable as the device is a surgical mesh and not an AI-assisted diagnostic or intervention system. No human readers or AI assistance are involved in its primary function or evaluation for this premarket notification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a surgical mesh and not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on:
- Objective Material Properties: Measurements of mesh weave characteristics, pore size, density, thickness, stiffness, burst strength, tear resistance, and suture pullout strength.
- Biocompatibility Standards: Results demonstrating adherence to ISO 10993 standards for various biological responses (cytotoxicity, sensitization, systemic toxicity, etc.).
- In vivo Animal Study Data: Characterization of mechanical strength retention and resorption profile.
- Comparison to Predicate: Demonstrating equivalence to a legally marketed predicate device (TephaFLEX® Mesh) with an established safety and effectiveness profile.
8. The sample size for the training set
This is not applicable as there is no "training set" in the context of an AI/ML powered device. The evaluation is based on in vitro and in vivo testing of the physical device.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set." The ground truth for the evaluation was established through standardized testing procedures, leveraging data from the predicate device that had undergone similar rigorous testing and obtained FDA clearance.
§ 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.