(32 days)
The CollaMend FM 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, fenestrated, off-white sheet of lyophilized, acellular 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 via fenestrations 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.
This is a 510(k) summary for a medical device called the CollaMend FM Implant, which is a surgical mesh. This document does not describe a study involving an algorithm or AI. It focuses on demonstrating substantial equivalence to predicate devices based on material and manufacturing process similarities, with a minor design difference (fenestrations). Therefore, many of the requested categories are not applicable.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
This document does not present quantitative acceptance criteria or specific performance metrics in a table format as would be typical for an AI/algorithm study. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (non-toxic, non-sensitizing) | Meets this criterion based on testing of the predicate CollaMend Implant, as the CollaMend FM Implant is made from the same source material. |
| Structural Integrity (strength, endurance) | Cross-linked to increase strength and endurance; fenestrations are the only design difference from the predicate, implying similar overall structural integrity with added benefits for tissue ingrowth. |
| Ability to reinforce soft tissue, e.g., hernia repair | Indicated for this use, similar to predicate devices. |
| Allows cellular infiltration and replacement by host tissue | Fenestrations are explicitly designed for this purpose, improving upon the predicate CollaMend Implant in this aspect for "a more convenient pathway for tissue ingrowth in-vivo." |
| Sterility verification (Ethylene Oxide) | Sterilized similarly to predicate. |
| Rehydration properties (before implantation) | Requires rehydration for a minimum of 3 minutes, similar to one predicate, and differing from another predicate (SIS Hernia Repair Device) which requires 10 minutes. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This document is a 510(k) submission for a device, not a study evaluating an AI/algorithm's performance on a specific test set. The "test set" for this submission refers to the device itself and its material properties.
- Data Provenance: Not applicable in the context of an AI/algorithm. Biocompatibility data was derived from testing on the predicate CollaMend Implant. The materials used are porcine dermal collagen.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There isn't a "ground truth" established by experts in the context of an AI/algorithm's performance evaluation. The "ground truth" for device safety and effectiveness is established through biocompatibility testing, material characterization, and comparison to legally marketed predicate devices, as reviewed by FDA regulatory experts.
4. Adjudication method for the test set:
- Not applicable. No adjudication method for an AI/algorithm test set is mentioned.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a medical device (surgical mesh), not an AI/algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- Not applicable in the context of AI. The closest equivalent to "ground truth" here is the established safety and effectiveness of the predicate devices (Bard CollaMend Implant and SIS Hernia Repair Device) through prior regulatory clearance and documented biocompatibility. The performance data relies on the inherent material properties and design, validated by comparison to these predicates.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI/algorithm, there is no training set or associated ground truth establishment process in that context.
§ 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.