(186 days)
The PerFix ™ Light Plug with HydroLight™ Onlay is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
The PerFix™ Light Plug with HydroLight™ Onlay (also referenced as "PerFix™ Light Plug HL" and "PerFix™ Light HL" in the submission) is a permanent, tissue contacting implant.
The PerFix™ Light Plug with HydroLight™ Onlay is comprised of two components: the BARD® PerFix™ Light Plug (hereon referred to as "plug") cleared in K092032; and the onlay, a Lightweight Large Pore Mesh (LLPM) with HydroLight™ hydrogel technology. The HydroLight™ hydrogel coating is a 90:1 mixture of polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG).
The provided text describes the regulatory clearance (K153236) for a medical device called the "PerFix™ Light Plug with HydroLight™ Onlay." It does not describe an AI/ML device or a study involving acceptance criteria for an AI/ML algorithm's performance.
Therefore, most of the requested information regarding AI device acceptance criteria, performance, sample sizes, ground truth, expert consensus, and MRMC studies is not applicable to the provided document.
However, I can extract information related to the device's performance testing and the studies conducted to support its substantial equivalence.
Here's the relevant information based on the document provided:
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "All samples tested met the established acceptance criteria." and "The PerFix™ Light Plug with HydroLight™ Onlay passed all test requirements and demonstrated substantial equivalence to the test results of the predicate device." However, it does not provide specific numerical acceptance criteria or detailed numerical results for each test. Instead, it lists the types of performance tests conducted.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Indicated device is biocompatible per referenced standards (FDA Blue Book Memorandum #G95-1, ISO 10993-1) | Met criteria. Specific tests conducted: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Genotoxicity, Implantation (Subcutaneous at 4, 8, and 13 weeks), Toxicological Assessment. Results indicate the subject device is biocompatible. |
| Bench Testing (Physical/Performance Characteristics) | Established acceptance criteria (specifics not detailed) | Met criteria. Specific tests conducted: Mesh Thickness, Mesh Weave Characteristics, Monofilament Diameter, Pore Size, Device Weight, Mesh Density (Linear), Tensile Strength, Device Stiffness, Suture Pull Out Strength, Burst Strength, Tear Resistance, Material Interaction Testing. Performance demonstrates the Onlay component does not adversely affect safety/effectiveness and shows substantial equivalence to the predicate. |
| Animal Study (In-vivo) | Established acceptance criteria (specifics not detailed) | Met criteria. Specific studies conducted: |
| - Histological Characterization Comprehensive Rat GLP Study: Evaluated host inflammatory/fibrotic response and presence/absence of hydrogel coating following subcutaneous implantation over a simulated abdominal surgical defect in the rat. | ||
| - Acute GLP Porcine Study: Determined tissue plane conformance and positioning aid properties following placement in the subcutaneous muscular abdominal tissue plane in the porcine model. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Biocompatibility Testing: Not specified for each test, but generally involves specific sample counts per test.
- Bench Testing: "All samples tested met the established acceptance criteria." The specific number of samples for each bench test is not provided.
- Animal Studies:
- Rat GLP Study: "Comprehensive Rat GLP Study," specific number of rats not provided.
- Porcine Study: "Acute GLP Porcine Study," specific number of pigs not provided.
- Clinical Studies (referenced as supporting data, not primary performance studies):
- Champault et al. (2011): Not specified in this document, but the citation indicates a "prospective, multicenter study" on inguinal hernia repair.
- Tollens et al. (2014): "100 Consecutive Patients." "Prospective, Single Center, Single Surgeon's Experience."
- Adhesix™ Intraoperative Handling Characteristics Data: "EU Clinical Experience."
- Testimonials: Dr. Millikan's preclinical evaluation, Dr. Tollens' testimonial.
- Data Provenance: For the clinical data, one study mentions "EU Clinical Experience." The animal studies are assumed to be conducted in a controlled lab environment, likely in the US, but the country of origin is not explicitly stated. The bench testing is also implicitly from the manufacturer's lab. All studies appear to be prospective for their specific designs (e.g., animal studies, clinical trial).
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 information is not applicable as the device is a surgical mesh, not an AI/ML diagnostic or image analysis tool. There is no concept of "ground truth" expert consensus in the same way an AI algorithm would have. The performance is assessed through laboratory tests, animal studies, and referenced clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it's not an AI/ML device requiring expert adjudication of results.
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, not an AI/ML system.
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, not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As this is not an AI/ML device, the concept of "ground truth" for algorithmic performance isn't directly applicable. However, for the various tests:
- Biocompatibility: Standards (ISO 10993) and established biological responses.
- Bench Testing: Mechanical and physical properties measured against established engineering specifications.
- Animal Studies: Histopathological findings, observations of tissue conformance and positioning aid properties.
- Clinical Data (supporting only): Patient outcomes from surgical repair procedures (e.g., hernia repair).
8. The sample size for the training set:
This is not applicable as the device is a hardware implant (surgical mesh), not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable as the device is a hardware implant (surgical mesh), not an AI/ML model.
§ 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.