(29 days)
OviTex PRS 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.
OviTex PRS is a sterile reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Polyglycolic Acid (PGA) or Polypropylene (PP), known as OviTex PRS (STR) (or OviTex PRS Short Term Resorbable) and OviTex PRS PP (or OviTex PRS Permanent), respectively. The device contains unidirectional fenestrations to allow for stretching in a uniaxial direction. The polymer imparts additional structure to the ECM and maintains device integrity through the initial phases of healing. OviTex PRS is provided in various shapes and sizes to suit surgeon preference and nature of the soft tissue repair in plastic and reconstructive surgery. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.
The provided text is a 510(k) summary for the OviTex PRS surgical mesh. It describes the device, its intended use, and compares it to a legally marketed predicate device (Endoform Restella).
However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The OviTex PRS is a surgical mesh, a physical medical device, not an AI/ML software device. Therefore, the requested information regarding AI/ML device performance metrics, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details are not applicable to this submission.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section discusses non-clinical testing related to the physical properties of the mesh (tensile strength, compliance, suture retention) and shelf-life, which are relevant for a physical surgical mesh. This section confirms that the two-layer OviTex PRS (STR) devices meet specifications and that the shelf life extension for OviTex PRS Permanent was validated.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and AI/ML study results because the provided text pertains to a physical medical device (surgical mesh), 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.