(131 days)
Phasix ST Mesh with Open Positioning System 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 open positioning system is intended to facilitate the placement, positioning and fixation of the mesh during open ventral hernia repair.
Phasix™ ST Mesh with Open Positioning System is a sterile, single-use device for prescription use only. It is a bi-layer mesh comprised of Phasix™ ST Mesh (K173143, forms posterior layer) and Phasix™ Mesh (K161424, forms anterior layer) stitched together with a 10 mil P4HB monofilament. The combination of the two distinct layers forms a pocket to accommodate a preinserted removable accessory. The subject device is designed for reinforcement of soft tissue deficiencies during open ventral hernia repair. The subject device and reference device have identical intended use for the mesh i.e. soft tissue repair/ reinforcement.
The removable open positioning system is an accessory with polypropylene (PP) handle attached to a Polytetrafluoroethylene (PTFE) guide. The accessory comes preinserted into the mesh pocket to aid with placement, positioning, and fixation. The center marking on the positioning guide will aid with proper centering and orientation over the defect. The accessory is removed following the initial fixation and then discarded. The intended use of the accessory is similar to the SorbaFlex Memory Technology utilized in the Ventrio™ ST Hernia Patch (K101920).
The provided text is a 510(k) summary for the Phasix ST Mesh with Open Positioning System, a surgical mesh device. The document details the device's characteristics, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.
Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:
No specific acceptance criteria table or quantitative performance metrics are explicitly stated in the provided document beyond qualitative "Pass" results for biocompatibility and statements that performance tests "successfully met the established acceptance criteria." The document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices through various tests rather than setting and meeting independent quantitative acceptance criteria for device performance.
However, we can infer the types of acceptance criteria that were likely in place based on the tests conducted and the general regulatory framework for medical devices. The "study" proving the device meets these (largely implied) acceptance criteria refers to the various performance tests and animal studies conducted.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not provide a specific table of quantitative acceptance criteria with corresponding performance values. Instead, it reports qualitative "Pass" results for biocompatibility and states that "performance test results demonstrate that subject device successfully met the established acceptance criteria."
Here's a conceptual representation based on the tests mentioned:
| Acceptance Criteria Category | Specific Test/Attribute | Reported Device Performance/Outcome |
|---|---|---|
| Biocompatibility | MEM Cell Cytotoxicity Elution | Pass |
| Intracutaneous Reactivity | Pass | |
| Acute Systemic Toxicity | Pass | |
| ISO Material Mediated Rabbit Pyrogenicity | Pass | |
| Guinea Pig Maximization Test (Sensitization) | Pass | |
| Material/Chemical Characterization | Pass | |
| Material/Mechanical Properties | Mesh Pore Size (Major and Minor) | Met established acceptance criteria |
| Gel Disruption | Met established acceptance criteria | |
| Ball Burst | Met established acceptance criteria | |
| Tear Strength (Cross and Machine direction) | Met established acceptance criteria | |
| Suture Retention Strength (Cross and Machine Direction) | Met established acceptance criteria | |
| Open Positioning System Functionality | 15 Degree Recoil | Met established acceptance criteria |
| Grip Strength | Met established acceptance criteria | |
| Pocket Integrity | Met established acceptance criteria | |
| Open Positioning System (accessory) removal force | Met established acceptance criteria | |
| Handle Attachment Strength | Met established acceptance criteria | |
| Three Tack Pluck | Met established acceptance criteria | |
| Usability (Design Validation) | IFU (Instructions for Use) | Passed (Usability demonstrated) |
| Insertion | Passed (Usability demonstrated) | |
| Positioning and Placement | Passed (Usability demonstrated) | |
| Fixation | Passed (Usability demonstrated) | |
| Removal | Passed (Usability demonstrated) | |
| Open Ventral Hernia Repair (overall procedure) | Passed (Usability demonstrated) | |
| In vivo Performance (Animal Study) | Mesh conformance | Comparable to predicates |
| Peritoneal tissue attachments (% area coverage and tenacity) | Comparable to predicates | |
| Percentage of mesh contracture | Comparable to predicates | |
| Histological evaluation (inflammatory/fibrotic response, vascular integration, Collagen deposition/remodeling, tissue ingrowth) | Comparable to predicates | |
| Mechanical tissue ingrowth properties via T-peel analysis | Comparable to predicates |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The specific sample sizes for each in vitro biocompatibility test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity/sensitization) are not explicitly stated in the summary.
- Product (Bench) Testing: The specific sample sizes (n-values) for each mechanical test (e.g., number of meshes tested for tear strength, number of accessories for removal force) are not explicitly stated.
- Animal Studies: The study was "a comprehensive 4 week GLP study in a porcine model." The number of porcine subjects is not specified.
- Data Provenance: All data appears to be prospective testing conducted specifically for this 510(k) submission. The country of origin for the data generation (where the tests were performed) is not specified, but given the submitter (Davol Inc., C. R. Bard, Inc. located in Warwick, RI, USA), it's highly likely the studies were conducted in the USA or by labs compliant with US regulations.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable in the context of this 510(k) summary. The device is a physical surgical mesh, not an AI/software device that requires ground truth derived from expert consensus for image interpretation or diagnosis. The "ground truth" for the performance sections is established through validated laboratory testing methods and histological/mechanical evaluation in the animal study.
- For the "Design Validation Usability Test," it implicitly involves users (likely surgeons or medical professionals) to validate the device's usability, but the number or their qualifications are not specified.
4. Adjudication Method for the Test Set
- This information is not applicable as it typically refers to the process of reconciling disagreements among multiple human readers for diagnostic interpretation (e.g., in AI studies).
- For the bench and animal studies, "adjudication" would involve standard laboratory practices for data collection, analysis, and statistical evaluation, overseen by internal quality systems. The specific mechanisms for resolving data discrepancies, if any, are not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging AI devices where the performance of human readers with and without AI assistance is evaluated. The Phasix ST Mesh is a physical surgical device, not a diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a surgical mesh; it does not involve algorithms or AI that would have a standalone performance. Performance is evaluated through bench testing and preclinical animal models.
7. The Type of Ground Truth Used
- Biocompatibility Testing: Ground truth is established by standard, recognized in vitro and in vivo biological assays with predefined endpoints and pass/fail criteria (e.g., cytotoxicity, systemic toxicity, sensitization).
- Product (Bench) Testing: Ground truth is established by engineering specifications, material science principles, and validated test methods to measure physical and mechanical properties. The "acceptance criteria" for these tests would be derived from these engineering specifications and comparison to predicate device characteristics.
- Animal Studies: Ground truth is established by histopathological evaluation, gross anatomical observation (e.g., tissue attachments, mesh contracture), and mechanical testing of tissue samples (e.g., T-peel analysis) by qualified personnel (e.g., pathologists, veterinary specialists), against predefined biological response expectations and comparative analysis with predicate devices.
8. The Sample Size for the Training Set
- Not applicable. The Phasix ST Mesh is not an AI/machine learning device; therefore, there is no "training set." The testing performed is for device validation and verification, not for training a model.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, this question is irrelevant.
§ 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.