(81 days)
VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligaments.
In these procedures, VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples, and sutures.
VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear hydrogel (Sheet) and a wetting Solution. The clear Sheet is a thin membrane of alginate and hyaluronic acid. VersaWrap Sheet is easy to handle, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet a gelatinous, tissue adherent layer (gel). The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a double peel pouch.
The provided text is a 510(k) premarket notification decision letter and a 510(k) summary for a medical device called VersaWrap®. This document primarily focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device, rather than detailed performance and validation studies typically found for AI/ML-based devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves an AI device meets acceptance criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance data, or ground truth types.
- Information on training set sample size or how ground truth was established for a training set.
The document states: "Based on the risk-based assessment no additional testing is required to support the additional determination of substantial equivalence. The prior non-clinical and animal testing for the device were used to support the extended indications. Based on the risk-based assessment no clinical testing is required to support the additional determination of substantial equivalence." This indicates that the approval is based on equivalence to a previously approved device, not on new performance studies for an AI/ML component.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.
§ 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.