(227 days)
The Phasix™ Plug and Patch is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
The proposed Phasix™ Plug and Patch utilizes a fully resorbable poly-4-hydroxybutrate (P4HB) polymer material pre-formed into a three-dimensional (cone shape) configuration constructed of a fluted outer layer and multiple inner layers (petals) of mesh attached at the tip. The inner petals and cones are sewn together at the tip with a single P4HB monofilament thread. The inner petals allow the device to conform readily to defects of various sizes while the structure of the small inter-fiber pores of the P4HB mesh allows for a prompt fibroblastic response and allows tissue in-growth. The cone shape configuration of the device allows it to expand and reduce in conformation with the immediate anatomy so that the repair is tension-free. The petals can be removed to customize the Phasix Plug to each individual patient. The Phasix Plug is available in several sizes. A flat mesh onlay patch is packaged with each Phasix Plug. The onlay is also fully resorbable and is made from the same P4HB monofilament as the Phasix Plug. Unlike the plug, the onlay patch is available in only one size but is customizable.
The provided text describes the Phasix™ Plug and Patch device and its predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain the specific type of information requested about acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-driven device.
The document is a 510(k) summary for a surgical mesh, which is a physical medical device, not an AI or algorithm-based diagnostic tool. Therefore, many of the requested points (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable or not present in this type of submission for a physical surgical implant.
Here's a breakdown based on the information available in the provided text, and where it falls short of your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the format requested for a quantifiable acceptance criteria and performance metrics. The document broadly states that "performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device."
Instead of a table with specific acceptance criteria, the document describes the types of tests performed:
- Bench Testing:
- Physical characteristics: mesh weave, mesh pore size, device density, device thickness, device stiffness.
- Performance evaluations: burst strength, tear resistance, suture pullout strength.
- Preclinical Studies:
- Porcine model (simulated ventral hernia repair): mechanical analysis, histological analysis, molecular weight properties post-implantation.
- In-vivo rat study: percentage area mesh contracture and host inflammatory/fibrotic response post-implantation.
- Biocompatibility Testing: Conducted according to ISO 10993-1 standards.
The document concludes that "All test results provided in this submission support the safety and effectiveness of the proposed Phasix Plug and Patch device for its intended use and demonstrate that the proposed Phasix Plug and Patch device is substantially equivalent to its predicate devices, PerFix Light Plug and TephaFlex Mesh." This is the general acceptance criterion for a 510(k) submission – demonstrating substantial equivalence to a legally marketed predicate device.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified for any of the individual tests. The text mentions a "comprehensive study... in a porcine model" and "An in-vivo study... in rats," but doesn't give numbers of animals used.
- Data Provenance: Not specified for individual tests. The studies are described as "preclinical" and "in-vivo," indicating animal model testing rather than human clinical data. The country of origin of the data is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This document describes a physical medical device, not a diagnostic algorithm that would require expert-established ground truth from images or other data. The "ground truth" here would be the physical measurements, biological responses in animal models, and integrity of the device itself.
4. Adjudication Method for the Test Set
N/A. As above, this is not applicable for the type of device and studies described.
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
N/A. This is a physical surgical mesh, not an AI or imaging diagnostic device. No human readers or AI assistance are involved in its performance or evaluation in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's evaluation would be:
- Pre-defined physical specifications (e.g., mesh weave, pore size, density, thickness, stiffness).
- Quantifiable mechanical properties (e.g., burst strength, tear resistance, suture pullout strength).
- Biological outcomes in animal models (e.g., mechanical analysis, histological analysis, molecular weight properties post-implantation, percentage area mesh contracture, host inflammatory/fibrotic response).
- Biocompatibility as defined by ISO 10993-1 standards.
8. The sample size for the training set
N/A. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
N/A. Not an AI/ML device.
In summary: The provided document is a 510(k) summary for a surgical mesh, which evaluates the physical and biological properties of the device to demonstrate substantial equivalence to predicate devices. It does not contain the information points typically associated with the development and validation of an AI/algorithm-driven device like acceptance criteria based on diagnostic performance, expert-established ground truth, or multi-reader studies.
§ 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.