(9 days)
Permacol® Surgical Implant is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.
Permacol® Surgical Implant Crosslinked Porcine Dermal Collagen Mesh
This 510(k) summary (K043366) is for Tissue Science Laboratories, plc's Permacol® Surgical Implant Crosslinked Porcine Dermal Collagen Mesh. The submission primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and performance data from biocompatibility and bench testing.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxic to biological tissues | "The biocompatibility test results show that the materials used in the design and manufacture of the device are non-toxic..." |
| Non-sensitizing to biological tissues | "...non-sensitizing to biological tissues." | |
| Material Performance | Materials consistent with intended use | "...new techniques and results demonstrate that the materials are consistent with the intended use." |
| Physical Performance | Meet performance criteria during intended use | "Laboratory tests demonstrate that the Permacol® Surgical Implant will meet chosen and the design utilized in manufacturing criteria of performance during their intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for biocompatibility or bench testing. It only generally refers to "test results" and "laboratory tests."
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data. However, the manufacturer is in the UK, suggesting the tests were conducted under their guidance, possibly in the UK or a contract lab.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given document. Biocompatibility and bench testing usually rely on standardized protocols and laboratory measurements rather than expert human assessment for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment, which is not the case for the described biocompatibility and bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study was mentioned or indicated. The submission focuses on substantial equivalence based on material and mechanical properties, not clinical efficacy comparisons with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a surgical mesh, not a medical imaging or AI diagnostic algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
For biocompatibility, the ground truth is established by standardized biological assays and observations for cellular response, toxicity, and sensitization, compared against established biological safety limits.
For physical performance and material characterization (bench testing), the ground truth is established by objective measurements of properties like tensile strength, elasticity, pore size, degradation rate, etc., compared against pre-defined engineering specifications or comparisons to predicate devices' known properties.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for a physical device, there is no ground truth to establish for it.
Summary of Device Performance Study:
The provided 510(k) summary indicates that the substantial equivalence of the Permacol® Surgical Implant is supported by:
- Biocompatibility testing: This demonstrated that the materials used are non-toxic and non-sensitizing. The "ground truth" here is the biological response observed in standardized tests, confirming the material's safety for biological contact.
- Bench testing (laboratory tests): These tests confirmed that the device's materials are "consistent with the intended use" and that the product "will meet chosen and the design utilized in manufacturing criteria of performance during their intended use." The "ground truth" here is objective physical and mechanical measurements compared against predetermined specifications and predicate device characteristics.
The submission does not include human clinical trial data, MRMC studies, or AI algorithm performance data, as these are not relevant to the type of device and the pathway chosen for regulatory clearance (510(k) substantial equivalence). The focus is on the device's physical and biological properties.
§ 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.