(33 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 or reinforcement in plastic and reconstructive surgery.
The proposed device is a sterile, solid, sheet of lyophilized, acellular porcine dermal collagen and its constitucnt 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 1 mm. 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.
The provided text describes the Bard CollaMend™ Implant, a surgical mesh, and its premarket notification (K063170 and K063178 for the FDA clearance letter). The focus of this submission is to demonstrate substantial equivalence to existing predicate devices, particularly to expand the indications for use of an already marketed Bard CollaMend® Implant.
Based on the provided text, the concept of "acceptance criteria" and quantifiable "device performance" as might be found in a study for a diagnostic AI device is not directly applicable. This is a 510(k) submission for a medical device (surgical mesh), not a software or AI-driven diagnostic tool. The performance is assessed through various tests to confirm the material's properties and biological interactions rather than accuracy metrics like sensitivity or specificity.
Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a surgical mesh, "acceptance criteria" are typically related to material properties, biocompatibility, and functional performance within the body, rather than diagnostic accuracy. The document states that the device met established specifications. Specific numerical acceptance criteria are not provided in the summary.
| Acceptance Criterion (Inferred from text) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Non-toxic and non-sensitizing to biological tissues consistent with its intended use. |
| Functionality and in-growth characteristics | Confirmed in animal implant study, comparable to predicate Permacol Implant. |
| Material choice, manufacturing process, design | Met established specifications necessary for consistent performance during its intended use. |
| Additional Indication Equivalence | Similar in design, manufacturing, and basic material properties to other predicate devices with the expanded indication. |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Implant Study: The text mentions "An animal implant study was performed" but does not specify the sample size (number of animals or implants).
- Data Provenance: The animal study is the primary "test set" described. No explicit mention of country of origin is made, but it is implied to be within the scope of regulatory standards for a US FDA submission. The study is prospective in nature as it evaluates the implant in an animal model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For an animal study evaluating tissue integration and functionality of a surgical mesh, ground truth would likely be established through histological analysis and gross observation by veterinary pathologists or experts in tissue engineering/implant biology.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical device (surgical mesh), not an AI diagnostic tool that would involve interpretation by human readers.
6. Standalone Performance Study
Yes, in essence, the described studies (biocompatibility testing, animal implant study, and laboratory test results) represent a standalone evaluation of the device's characteristics and performance. These studies are designed to demonstrate the inherent properties and functionality of the Bard CollaMend Implant itself.
7. Type of Ground Truth Used
- Biocompatibility: Likely established through standardized in-vitro and in-vivo toxicology tests (e.g., cytotoxicity, irritation, sensitization assays) with defined endpoints.
- Animal Implant Study: Ground truth would be based on gross and histological examination of explanted tissues, evaluating parameters such as inflammation, tissue integration, neovascularization, and integrity of the mesh.
8. Sample Size for the Training Set
Not applicable in the context of this device. The term "training set" is relevant to machine learning and AI, which this device is not. The manufacturing process of the device itself would be subject to quality control and process validation, possibly involving "batches" or "lots" of material, but not a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 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.