(109 days)
The SURGISIS® Biodesign Tissue Graft is intended to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.
The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.
This device is intended for one-time use.
The SURGISIS® Biodesign Tissue Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a range of sizes. The device is packaged in a dried state, and is supplied sterile in a sealed double pouch system.
This 510(k) summary describes a medical device, the SURGISIS® Biodesign Tissue Graft, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the way a diagnostic AI/ML device submission would. This submission is for a material (surgical mesh), not a software algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established, standalone performance) are not applicable to this type of device submission.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (SURGISIS® Biodesign Tissue Graft K062697 and Veritas® Collagen Matrix K062915) in terms of intended use, materials, and technological characteristics. | The SURGISIS® Biodesign Tissue Graft is acting as its own predicate for K062697, and is substantially equivalent to Veritas® Collagen Matrix (K062915). It has the same technological characteristics and intended use, with the exception of the additional intended use for minimizing tissue attachment to viscera. Substantial equivalence was shown through bench and biocompatibility testing submitted in previous cleared 510(k)s. |
| Minimize tissue attachment to viscera. | "All studies concluded that SURGISIS® Biodesign Tissue Graft demonstrates minimal tissue attachment to the viscera when compared to a named predicate." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The document refers to "a number of animal studies."
- Data Provenance: "animal studies from published and unpublished literature." The country of origin is not specified but Cook Biotech Incorporated is based in West Lafayette, IN, USA. The studies would be considered prospective for the specific claims they aimed to prove.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The studies are animal studies, so the "ground truth" would likely be based on pathological and gross examination findings by veterinarians or researchers, rather than expert human interpretation of images or signals.
4. Adjudication method for the test set
- Not applicable as this is not an AI/ML diagnostic study. The "ground truth" would be determined by direct observation and scientific assessment in animal studies.
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
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- The "ground truth" was established through direct observation and measurement in animal studies, focusing on outcomes like tissue attachment to viscera.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of medical device submission.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.