(140 days)
Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness involving soft tissue repair, such as for the repair of hernias.
The Echo 2™ Positioning System is intended to facilitate the delivery and positioning of the mest during laparoscopic hernia repair.
The Phasix™ ST Mesh with Echo 2™ Positioning System is a sterile single use mesh preattached to the Echo 2™ Positioning System. The subject device is a combination of the FDA cleared Phasix™ ST Mesh (K173143) and the Echo 2™ Positioning System that is cleared by the FDA in the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294). The Echo 2™ Positioning System is removed following the mesh placement and fixation. As with the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294), many sizes of the subject device include an introducer tool accessory.
The subject device is intended for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias and will utilize a positioning system to facilitate the delivery and positioning of the mesh during laparoscopic hernia repair.
Procedures involving "laparoscopic hernia repair" also pertain to those which are conducted under laparoscopic visualization through a trocar, such as robotic assisted laparoscopic ventral hernia repair (LVHR).
The Phasix™ ST Mesh in the subject device is a fully resorbable mesh with a resorbable hydrogel coating and is identical to the secondary predicate device, Phasix™ ST Mesh (K173143). It is co-knitted using Poly-4-hydroxybutyrate (P4HB) and Polyglycolic Acid (PGA) fibers to form two sided mesh. The PGA side of the mesh is coated with a bioresorbable, chemically modified sodium hyaluronate (HA), Carboxymethylcellulose (CMC) and Polyethylene Glycol (PEG) based hydrogel. The fascial P4HB side of the mesh allows for a prompt fibroblastic response through its interstices, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral PGA side of the mesh coated with a bioresorbable hydrogel separates 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.
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 is observed in preclinical studies within 12 to 18 months, indicating loss in mechanical integrity and strength of the mesh. While fiber segments were observed at 18 months, they continued to degrade.
This Phasix™ ST Mesh (K173143) is preattached to the Echo 2™ positioning system on the hydrogel side of the mesh using nylon connectors. The Echo 2™ Positioning System is composed of nitinol wire, encased in a sealed nylon frame. A Polyethylene Terephthalate (PET) center hoisting suture is attached to the nylon frame. The Echo 2™ positioning system utilized in the subject device is identical in materials and construction to the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294).Once inserted into the abdomen, the positioning system facilitates both deployment and positioning of the mesh. After initial fixation is complete, the Echo 2™ Positioning System is manually detached from the mesh and then removed from the body through a trocar or skin incision.
The provided text describes a 510(k) premarket notification for a medical device called "Phasix™ ST Mesh with Echo 2™ Positioning System." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with strict acceptance criteria and a definitive study to prove the device meets those criteria from scratch.
Therefore, the information you're requesting regarding a detailed breakdown of acceptance criteria met by a specific study is not explicitly provided in the typical format of a clinical trial or performance study report. Instead, the document discusses performance data in the context of demonstrating similarity and equivalence to predicate devices.
Here's an attempt to answer your questions based on the available information, with explanations for what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that "All the samples of the subject device successfully met the established acceptance criteria and performed as intended and similar to the predicate devices" for the product testing specified.
The types of tests performed and their general outcomes are summarized below:
| Type of Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Conformity to ISO 10993-1 and established biocompatibility of known materials. No adverse interactions between components. | Successfully passed Cytotoxicity, Pyrogenicity, and Chemical Characterization tests. Demonstrated to be biocompatible with no adverse interactions between the Phasix™ ST Mesh and the Echo 2™ Positioning System. |
| Mechanical Testing | Mesh integrity (gel disruption), connector-to-mesh attachment strength, and ball burst performance comparable to predicate devices. | Passed all test requirements; test results demonstrated substantial equivalence to predicate devices. |
| Simulated Use Evaluations (Bench Top Simulator) | Satisfactory performance in delivery, support, access/fixation, and removal. | Successfully met established acceptance criteria and performed as intended and similar to predicate devices. |
| Performance Testing (Porcine Model) | Satisfactory performance in delivery, support, access/fixation, and removal. | Successfully met established acceptance criteria and performed as intended and similar to predicate devices. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Sizes: The document does not specify the exact sample sizes (e.g., number of meshes, animals, or test replicates) used for each individual test or evaluation. It broadly refers to "all the samples of the subject device."
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the focus on bench and animal testing, these are typically prospective laboratory or animal studies, not human clinical trials with geographical data.
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 to the type of tests described. The evaluations are primarily engineering, chemical, and biological performance tests (biocompatibility, mechanical, simulated use, animal model performance), not diagnostic or interpretative tasks requiring human expert "ground truth" in the way a medical imaging AI would. The "ground truth" for these tests is based on objective measurements and predefined specifications / predicate device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews of complex data (e.g., medical image interpretation) where there might be disagreement among reviewers. The tests described are laboratory and animal-based, with results determined by objective measurements and passing/failing criteria without such an adjudication process.
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. An MRMC study is designed to evaluate the performance of diagnostic devices, often medical imaging AI, and how it impacts expert human reader performance. The Phasix™ ST Mesh with Echo 2™ Positioning System is a surgical mesh with an associated positioning system, not a diagnostic device or AI software. There is no AI component in this device, nor is it intended for interpretation by human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical medical device (mesh and positioning system) used by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed can be characterized as follows:
- Biocompatibility: Established scientific standards (ISO 10993-1) and objective laboratory measurements for cytotoxicity, pyrogenicity, and chemical characterization.
- Mechanical Testing: Objective measurements against predefined engineering specifications and performance profiles of the predicate devices.
- Simulated Use Evaluations (Bench Top Simulator) & Performance Testing (Porcine Model): Observation and objective assessment of the device's functional performance (delivery, support, access/fixation, removal) against expected results and the demonstrated performance of predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. All the data described relates to verification and validation testing of the physical medical device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, this question is not relevant to the described device.
§ 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.