(43 days)
Veritas Collagen Matrix (Dry) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Veritas Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example, occlusion of the left atrial appendage during open chest procedures.
Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera.
Veritas Collagen Matrix is an implantable surgical mesh comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is procured in the United States from cattle less than 30 months of age.
Veritas Collagen Matrix allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. Veritas Collagen Matrix also minimizes tissue attachment to the device in case of direct contact with viscera.
This document is a 510(k) summary for the Veritas® Collagen Matrix (Dry). It states that the device is acting as its own predicate, meaning it's substantially equivalent to a previously cleared version of the same product. The submission focuses on a new method of attachment of the buttress to the stapler (an adhesive).
Given this, the document does not describe a study to prove the device meets acceptance criteria related to its primary function as a surgical mesh. Instead, the testing described is limited to the new adhesive.
Therefore, for most of your requested points, the answer will be "Not applicable" or "No information provided" as the provided text doesn't contain a detailed study proving the overall device performance against specific acceptance criteria.
However, I can extract information related to the scope of the current submission.
Here's a breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (for the new adhesive) | Reported Device Performance (for the new adhesive) |
|---|---|
| Biocompatibility of the adhesive | The testing presented in this submission is specifically related to the use of an adhesive, which is the new method for attachment of the buttress to the stapler. The testing focuses on the biocompatibility of the adhesive and its ability to allow the device to function as intended. (Implies satisfactory performance, no specific data or metrics provided for "biocompatibility") |
| Ability of the adhesive to allow the device to function as intended | The testing focuses on the ... ability [of the adhesive] to allow the device to function as intended. (Implies satisfactory performance, no specific data or metrics provided, and "function as intended" is not numerically defined) |
Note: The document explicitly states: "Veritas Collagen Matrix (Dry) is unchanged and previous testing applies." This means the core functionality of the collagen matrix as a surgical mesh was not re-evaluated in this submission, as it was already cleared in previous 510(k)s (K041669 and K062915).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
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)
- Not applicable. The study is on device components (adhesive biocompatibility and functionality), not on human-interpreted clinical data requiring expert ground truth establishment in the traditional sense of diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. (See #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
- No. This is a medical device for surgical mesh and adhesive, not an AI or diagnostic imaging device that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. (See #5)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The evaluation relates to physical and biological properties of the adhesive (biocompatibility, functional performance), not clinical ground truth in the context of disease detection or diagnosis.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #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.