(202 days)
Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use in the following types of soft tissue repair procedures: abdominal, inquinal, diaphragmatic, femoral, scrotal, . umbilical, and incisional hernias; . colon, rectal, urethral, and vaginal prolapse: muscle flap reinforcement; . . reconstruction of the pelvic floor; sacrocolposuspension; and . . urethral sling.
Permacol™ is a sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin
The prompt requests information on acceptance criteria and study details for a device, but the provided text describes a surgical mesh (Permacol™) and its 510(k) premarket notification. This type of medical device submission typically focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing specific quantitative acceptance criteria or conducting studies as would be done for a novel diagnostic algorithm.
Therefore, many of the requested data points (such as sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable or available in this type of submission. The provided text outlines biocompatibility testing and clinical experience used to support substantial equivalence and safety/effectiveness, but not a controlled clinical trial with specific numerical outcome measures against acceptance criteria in the way a diagnostic AI would have.
However, I can extract the information that is present and explain where the requested details are not provided.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance for Permacol™ Porcine Collagen Surgical Mesh
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (as implied by FDA submission) | Permacol™ Porcine Collagen Surgical Mesh Performance |
|---|---|
| Biocompatibility | The product passed all standard biocompatibility tests: Hemolysis, Cytotoxicity (elution method), Acute Systemic Toxicity, Implantation/Subchronic Toxicity, Genotoxicity (Ames Mutagenesis, Bone Marrow Micronucleus, Mouse Lymphoma Mutagenesis), Sensitization (Magnusson and Kligman), Pyrogenicity. |
| Histological Evaluation | Histological evaluation after 6 months implantation in rats demonstrated the material is safe and well tolerated. |
| Clinical Safety & Tolerance | "Clinical experience in several hundred patients in Europe also has demonstrated that Permacol™ is safe and well tolerated." |
| Clinical Outcomes (Effectiveness) | Case histories for 60 patients showed "successful clinical outcomes were achieved in nearly all cases." |
| Adverse Effects | "No product-related adverse effects were noted in any of the procedures." |
| Ease of Handling | Case histories for 60 patients demonstrated Permacol™ is "easy to handle." |
| Substantial Equivalence (Overall) | "Permacol™ is substantially equivalent to the predicate devices in terms of its intended use, specific indications, and performance." Minor technological differences "do not raise any new concerns of either safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size for Human Clinical Experience: "several hundred patients in Europe" for general clinical safety and tolerance.
- Sample Size for Detailed Case Histories: 60 patients for detailed evaluation of handling and clinical outcomes.
- Data Provenance: Clinical experience in Europe (specifically mentioned). The studies referenced appear to be retrospective collections of "case histories" rather than a prospective, randomized controlled trial.
- Animal Study Sample Size: Not explicitly stated, but mentioned as "implantation in rats."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not provided: This type of information is typically associated with diagnostic device evaluations, especially those involving expert interpretation of medical images or data. For a surgical mesh, "ground truth" would be established through direct clinical observation of patient outcomes and histological analysis, not through expert consensus on diagnostic interpretations. The document references "clinical experience" and "histological evaluation" which implies medical professionals (surgeons, pathologists) were involved, but the specific number or qualifications are not detailed as they would be for a diagnostic study.
4. Adjudication method for the test set
- Not Applicable / Not provided: Adjudication methods (e.g., 2+1, 3+1) are typically used in diagnostic studies where multiple readers interpret data and discrepancies need to be resolved. This is not relevant for the type of clinical experience and biocompatibility testing described for a surgical mesh.
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 comparative effectiveness study, especially concerning AI assistance, is not relevant to a surgical mesh like Permacol™. This device is not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: Permacol™ is a physical surgical mesh, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used
- Biocompatibility Studies: Laboratory test results (e.g., cell viability, hemolytic index, mutagenicity assays) and histological findings from animal implantation.
- Clinical Experience: Direct observation of patient safety (adverse events), tolerance, and surgical outcomes (e.g., successful repair, ease of handling). These would be derived from clinical records and surgeon's assessments.
8. The sample size for the training set
- Not Applicable: Permacol™ is a manufactured device, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable: As there is no AI model or training set, this question is not relevant.
§ 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.