(198 days)
The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant is comprised of a section of mesh with suture tails containing suture barbs for tissue securement. The device and the delivery system are delivered sterile and are for single use only.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study proving the device meets those criteria, as one might find for an AI/ML medical device. The document is a 510(k) summary for a surgical mesh, which is a physical medical device.
The information primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against specific acceptance criteria in a quantitative sense typical of AI/ML evaluation.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) cannot be extracted from this document as they are not relevant to the type of device and submission presented.
However, I can extract the general "performance" information that is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance. | The Refine™ Support System is considered substantially equivalent in performance to the predicate device. |
| Conformance to specifications. | The device conforms to specifications. |
| Meets clinical user needs and intended uses. | The device meets clinical user needs and intended uses. |
| Meets user needs and requirements for performance. | Bench studies and cadaver evaluations substantiate that the Refine™ Support System meets user needs and requirements for performance. |
| No new risks or concerns regarding safety or effectiveness. | There are no new risks and concerns regarding safety or effectiveness of the device. |
| Supports reinforcement of soft tissue in plastic/reconstructive procedures. | Indicated for reinforcement of soft tissue in plastic or reconstructive procedures. |
2. Sample sized used for the test set and the data provenance
Not applicable/provided. This document pertains to a physical surgical mesh device, not an AI/ML algorithm that would typically have a "test set" in the computational sense. The "performance evaluations" and "comparison studies" mentioned are likely referring to bench testing and cadaver studies, but specific sample sizes are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided. This is not relevant for this type of device submission.
4. Adjudication method for the test set
Not applicable/provided.
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
For this physical device, "ground truth" would relate to the physical and functional properties of the mesh. The document mentions:
- Bench studies: These would likely test mechanical properties, structural integrity, etc. against pre-defined specifications.
- Cadaver evaluations: These would likely assess ease of delivery, tissue securement, and placement in a cadaveric model.
The "ground truth" for these tests would be the established engineering specifications, anatomical accuracy, and successful completion of surgical tasks in a simulated environment.
8. The sample size for the training set
Not applicable/provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable/provided. This is not an AI/ML 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.