(30 days)
SERI® Contour is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction.
SERI® Contour is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from pure silk fibroin. The device is a mechanically strong and biocompatible protein mesh. SERI® Contour is a sterile, single use only product and is supplied in a variety of sizes. ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI® Contour provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction.
The provided text is a 510(k) summary for a medical device (SERI® Contour) seeking substantial equivalence to a predicate device (SERI® Surgical Scaffold). As such, it focuses on demonstrating equivalence rather than establishing acceptance criteria against a defined clinical outcome or proving superiority. The information for a typical AI/software device performance study is not entirely available here because this is for a physical surgical mesh.
However, I will extract and infer the most relevant information based on the typical structure for a medical device efficacy study outlined in your request.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate) | Reported Device Performance (SERI® Contour) |
|---|---|---|
| Burst Strength | Exceed peak forces in the abdomen (specific numerical value not provided, but implied to be sufficient for abdominal pressure). | Verified to perform in excess of the maximum calculated, worst-case scenario of abdominal pressure. Equivalent to Scaffold at 3, 6, and 12-month evaluation in a large animal model. |
| Tissue Ingrowth | Supports tissue ingrowth. | Supported tissue ingrowth in a large animal model at 3, 6, and 12-month evaluation. |
| Biocompatibility | Biocompatible (based on predicate). | Same as predicate. |
| Sterilization | Sterilized (based on predicate). | Same as predicate. |
| Pliability/Drapability | (Implied: To meet clinical feedback for improved handling). | Increased pliability and drapability (due to larger pores and fully knitted mesh). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: "large animal model" – A specific number is not provided.
- Data Provenance: Prospective (implied by "evaluated in a large animal model" and "in vivo performance testing"). Country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. This is a pre-clinical performance study in an animal model, not a human clinical trial where expert clinicians would establish ground truth for diagnosis/outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. This refers to consensus among human readers for clinical ground truth, which is not relevant for this type of animal study.
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, an MRMC comparative effectiveness study was not done. This device is a surgical mesh, not an AI/software diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this term is not applicable. The device is a physical surgical mesh.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For the animal study, the ground truth was based on direct measurements of mechanical properties (burst strength) and histological/microscopic evaluation for tissue ingrowth at specified time points (3, 6, and 12 months) in the large animal model. This is a form of direct measurement and pathological assessment.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model that requires a training set. The "design change" and "clinical feedback" could be considered analogous to iterative development, but not a formal 'training set' in the AI sense.
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.