(60 days)
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
XenMatrix™ Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed hydrated in sterile saline for use in the reconstruction of soft tissue deficiencies.
This document describes a 510(k) submission for the XenMatrix™ Surgical Graft. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to proposed changes in the available sizes of the graft.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds in a table format. However, it mentions several non-clinical tests performed and that the device "meets the same product specifications and intended uses." The implied acceptance criteria for the expanded sizes are that they perform equivalently to the predicate device in these tests.
| Test Category | Specific Test Conducted | Reported Performance (Implicit Acceptance Criteria) |
|---|---|---|
| Mechanical Strength | Burst strength | Meets same product specifications as predicate device. |
| Tensile strength | Meets same product specifications as predicate device. | |
| Suture retention strength | Meets same product specifications as predicate device. | |
| Packaging Integrity | Seal strength | Not explicitly stated, but implied to meet requirements for ensuring sterility and product integrity. |
| Ship testing | Not explicitly stated, but implied to prevent damage during transport. | |
| Biocompatibility | Biocompatibility | Same as predicate device (acellular porcine dermal matrix). |
| Histology | Histology examination | Not explicitly detailed, but implied to be acceptable for a surgical graft. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical tests (burst strength, tensile strength, suture retention strength, etc.).
The data provenance is also not specified, but it's presumed to be from Davol Inc. and its testing facilities, likely in the US, as no other location is mentioned. The testing is described as "bench and pre-clinical testing," which suggests it's prospective testing conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The study performed was non-clinical (bench and pre-clinical testing) on a surgical graft, not a diagnostic device requiring expert interpretation of images or other data to establish a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as #3.
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
This question is not applicable. This submission is for a surgical graft, not an AI-powered diagnostic tool. No human reader studies were conducted or are relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device (surgical graft), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" implicitly refers to pre-defined product specifications and performance characteristics established for the predicate device and expected for the proposed device through accepted engineering and quality control standards. For the histological examination, the ground truth would be established by qualified histologists interpreting the tissue samples according to established biological criteria.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question 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.