(125 days)
Endoform Restella is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Endoform Restella is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with absorbable polyglycolic acid (PGA) and non-absorbable polypropylene (PP) suture material for use in plastic and reconstructive surgery. The 3-ply devices are available in sizes up to 400 cm² in arced rectangle, contour, and oval shapes.
The provided text is a 510(k) summary for the medical device "Endoform Restella." This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device for FDA clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Material Composition | Equivalent to predicate device. |
| Biocompatibility | Equivalent to predicate device. |
| Sterilization | Equivalent to predicate device. |
| Packaging Materials | Equivalent to predicate device. |
| Packaging Processes | Equivalent to predicate device. |
| Mechanical Strength | Meets product specifications. |
| Endotoxin | Meets product specifications. |
| Dimensional Verification | Meets product specifications. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of devices, number of tests performed) for the bench testing.
The data provenance is from non-clinical bench testing. The text does not provide country of origin or whether it's retrospective or prospective, though bench testing is inherently prospective in nature.
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 in the document. Bench testing typically relies on predefined engineering specifications rather than expert consensus on a 'ground truth' in the same way clinical data would.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods are typically relevant for human-interpreted data (e.g., imaging studies, clinical endpoints), not for objective bench test results like mechanical strength or endotoxin levels.
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 device is a surgical mesh; the concept of "human readers" and "AI assistance" is not relevant to its type of evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this medical device. The "Endoform Restella" is a physical surgical mesh, not an algorithm or AI performing a task. Its performance is evaluated through physical and material properties, not by an algorithm's output.
7. The type of ground truth used
The ground truth used for the non-clinical performance evaluation was based on product specifications and the characteristics of the predicate device. The device was deemed acceptable if it met these predefined specifications and demonstrated equivalence in key properties to the legally marketed predicate.
8. The sample size for the training set
This information is not applicable/not provided. The "Endoform Restella" is a physical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable to this medical device.
§ 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.