(129 days)
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, processed into monofilament fiber, and then knitted into a surgical mesh. Phasix™ Mesh is packaged individually as a sterile, single, flat mesh available in a wide range of shapes and sizes. Phasix™ Mesh provides immediate short-term support, and 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 is essentially complete within 12 to 18 months.
The provided document is a 510(k) Premarket Notification for a medical device called Phasix™ Mesh. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from scratch.
Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training data, etc., is not available within this type of regulatory submission. This document highlights that the proposed device is so similar to an already approved device that extensive new studies are not required.
Here's how to interpret the document in the context of your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The "acceptance criteria" here are implicitly that the proposed Phasix™ Mesh performs similarly or equivalently to the predicate Phasix™ Mesh (K142818) across various physical and biological characteristics. The FDA's substantial equivalence determination means they accepted that the proposed device is just as safe and effective as the predicate.
- Reported Device Performance: The document states that "The proposed Phasix™ Mesh demonstrated equivalent performance in comparison to the predicate device" for the following non-clinical tests:
- Mesh thickness
- Mesh knit construction
- Mesh pore size
- Mesh density
- Tensile strength
- Device stiffness
- Suture pullout strength
- Burst strength
- Tear resistance
- Specific performance values are NOT provided. The document only states "equivalent performance," implying that the results fell within acceptable ranges or were statistically comparable to the predicate.
2. Sample size used for the test set and the data provenance
- Test Set (Bench Testing): The specific sample sizes for the bench tests listed above are not reported in this summary.
- Data Provenance: The bench testing was conducted by the manufacturer, C.R. Bard, Inc. (Davol Inc. is the submitter). The country of origin for the data is not specified but would typically be the location of the manufacturing and testing facilities. These appear to be retrospective tests designed to compare the proposed device to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of physical/mechanical performance testing, "ground truth" is established through standardized engineering and materials science methods, not expert consensus in the clinical sense.
4. Adjudication method for the test set
- Not applicable. Adjudication is typically for clinical or interpretative tasks, not for objective physical measurements.
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
- No MRMC study was done. This device is a surgical mesh, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical mesh, not an algorithm.
7. The type of ground truth used
- For the bench tests, the "ground truth" is the objective measurement (e.g., actual mesh thickness, measured tensile strength) derived from standardized test methods.
- For biocompatibility and in-vivo studies, the "ground truth" is established through the results of standardized biological and animal tests. In this case, previous studies for the predicate device (K142818) were adopted because the proposed device uses the same materials and knit characteristics. These previous studies would have established biocompatibility based on ISO 10993-1 and characterized mechanical strength and resorption profiles in animal models.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable.
In summary: This document is a regulatory submission for a device seeking substantial equivalence to a predicate. It relies heavily on the fact that the proposed device uses almost identical technology and materials as an already-approved device, therefore adopting prior testing results rather than generating entirely new, extensive clinical or comparative effectiveness data. The "acceptance criteria" are effectively that the new device's physical and biological properties are equivalent to the predicate, as demonstrated through bench testing and by leveraging prior biocompatibility and animal study data.
§ 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.