(213 days)
Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh ("Permacol™ ") is intended to be used for reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.
Permacol™ is available in sheet form.
The provided text describes a 510(k) submission for a surgical mesh, Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria based on detailed performance metrics.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states "Mechanical testing of Permacol™ has been performed in accordance with FDA's Surgical Mesh 510(k) Guidance. The results demonstrate that Permacol™ provides appropriate tensile strength, elasticity, stiffness, suture pullout strength, tear resistance, and puncturability, for use in soft tissue repair."
However, specific quantitative acceptance criteria (e.g., minimum tensile strength of X MPa, elasticity range of Y-Z%) or the exact reported performance values are NOT provided in the submission summary. The FDA's 510(k) summary only states that the device "provides appropriate" values, implying that it met internal or guidance-recommended criteria without listing them.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not explicitly stated in the 510(k) summary (e.g., specific thresholds for tensile strength, elasticity) | Not explicitly stated in the 510(k) summary (e.g., actual measured tensile strength, elasticity values) |
| Qualitative statements from the document: | Qualitative statements from the document: |
| Appropriate tensile strength | Permacol™ provides appropriate tensile strength |
| Appropriate elasticity | Permacol™ provides appropriate elasticity |
| Appropriate stiffness | Permacol™ provides appropriate stiffness |
| Appropriate suture pullout strength | Permacol™ provides appropriate suture pullout strength |
| Appropriate tear resistance | Permacol™ provides appropriate tear resistance |
| Appropriate puncturability | Permacol™ provides appropriate puncturability |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size used for the mechanical testing.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "Mechanical testing of Permacol™ has been performed..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the "test set" in this context refers to mechanical properties of a medical device, not a diagnostic or clinical performance study requiring expert ground truth for interpretation (e.g., radiology images or pathology slides). The assessment is based on physical material properties.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as #3. Mechanical testing results are objective measurements, not subject to expert adjudication.
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 relevant for diagnostic devices where human readers interpret cases with and without AI assistance. This submission is for a surgical mesh, a physical implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This information is not applicable. The device is a surgical mesh, not an algorithm. The performance described relates to the physical characteristics of the mesh itself.
7. The Type of Ground Truth Used:
The "ground truth" here would be the objective measurements of the physical and mechanical properties of the Permacol™ mesh. This would involve laboratory-based testing methods to determine:
* Tensile strength
* Elasticity
* Stiffness
* Suture pullout strength
* Tear resistance
* Puncturability
These are intrinsic material properties and do not rely on expert consensus, pathology, or outcomes data in the way a diagnostic device would.
8. The Sample Size for the Training Set:
This information is not applicable. The Permacol™ mesh is a manufactured medical device, not an AI or algorithm that requires a "training set" in the computational sense. The document refers to its manufacturing process and testing of its final product properties.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8.
§ 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.