(228 days)
The Bard CollaMend Implant is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects, and for the surgical repair of damaged or ruptured soft tissue membranes.
The proposed device is a sterile, solid, sheet of lyophilized, accellular porcine dermal collagen and its constituent elastin fibers. It is processed to remove all non-collagenous cellular components and is cross-linked to increase strength and endurance. The proposed device allows cellular infiltration and replacement by host tissue, forming a strong repair of soft tissue defects. The proposed device will be made available in various sizes and shapes, ranging from a 4" x 6" ellipse to a 10" x 14" rectangle. The thickness of the devices will be approximately 1mm. Surgeons will need to rehydrate the product before implanting it into the patient. The proposed device will be marketed as a sterile, single use device.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Bard CollaMend Implant:
Based on the provided document, the information regarding acceptance criteria and detailed study methodology is quite limited. This appears to be a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting full clinical trial results with explicit acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it makes general statements about performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic and non-sensitizing | "Biocompatibility testing will be completed and passed before the Bard CollaMend Implant is released. These biocompatibility test results will show that the material used in the design and manufacture of the proposed device is non-toxic and non-sensitizing to biological tissues consistent with its intended use." (Awaiting results/not explicitly presented in this summary) |
| Functionality and in-growth characteristics (comparable to predicate) | "An animal implant study was performed to confirm the functionality and in-growth characteristics of the Bard CollaMend Implant as compared to the predicate Permacol Implant." (Confirmation by study) |
| Meeting established specifications for consistent performance | "Laboratory test results demonstrate that the material chosen, the manufacturing process, and the design utilized for the Bard CollaMend Implant will meet the established specifications necessary for consistent performance during its intended use." (General statement of meeting specifications) |
| Substantial Equivalence to Predicate Devices | The overall submission aims to demonstrate substantial equivalence to Permacol® Implant, Mersilene® Polyester Fiber Mesh, and FortaGen® Porcine Collagen Surgical Implant for the intended use of reinforcing soft tissue where weakness exists. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "An animal implant study" but does not specify the number of animals or implants used in this study.
- Data Provenance: The study was an "animal implant study." The country of origin is not specified, but it would have been conducted by or for Davol Inc., a US-based company. It is a prospective study as it involves implantation of the device as part of the study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. Given it was an animal study focused on functionality and in-growth, the "ground truth" would likely be based on histological analysis by veterinary pathologists or expert animal researchers, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC comparative effectiveness study was not reported. This device is a surgical implant (medical device, not an AI or imaging diagnostic tool), so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was not reported. This device is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used:
- For the "animal implant study," the ground truth for evaluating "functionality and in-growth characteristics" would typically come from histopathological analysis of tissue samples from the implanted animals, along with macroscopic observations and possibly biomechanical testing.
8. The Sample Size for the Training Set:
- This information is not applicable as this is not an artificial intelligence/machine learning device that would require explicit training data. The "training" for this type of device development involves materials science, bioengineering, and preclinical testing to optimize the device design and manufacturing process.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable for the same reason as above. Device development in this context involves iterative design, bench testing, and potentially earlier animal studies to refine the product, rather than establishing "ground truth" for an AI training set based on expert consensus. The "ground truth" in manufacturing would be based on established material specifications and quality control measures.
§ 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.