(99 days)
Polydioxanone Surgical Scaffold is indicated for use in reinforcement of soft tissue where weakness exists.
Polydioxanone Surgical Scaffold™ is a resorbable, colorless, monofilament knit surgical mesh. Polydioxanone Surgical Scaffold™ is packaged individually and is provided sterile as a flat mesh that can be cut to the desired shape and size. Polydioxanone Surgical Scaffold™ is made entirely of uncolored and undyed polydioxanone (PDO) thread, which is similar in form to PDO sutures. The threads degrade via bulk hydrolysis once implanted. Strength retention decreases followed by mass loss in the threads. In vitro degradation studies show that Polydioxanone Surgical Scaffold™ threads retain some burst strength for 3 months, but not beyond that time. In vivo implantation studies in swine demonstrate that Polydioxanone Surgical Scaffold™ takes up to 9 months to fully absorb.
The provided text describes the submission for a 510(k) premarket notification for the "Polydioxanone Surgical Scaffold™" surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device (TIGR® Matrix Surgical Mesh), rather than proving that the device meets specific acceptance criteria through a clinical study involving AI or human readers evaluating patient data.
Therefore, I cannot fulfill your request to describe a study that proves the device meets acceptance criteria using the information provided. The document outlines:
- Bench testing: Comparison of physical properties (dimensions, burst strength, suture pullout strength, tear strength, stiffness, tensile strength) between the Polydioxanone Surgical Scaffold™ and the predicate device.
- In vitro degradation study: To confirm strength loss duration and time to full absorption.
- Biocompatibility testing: According to ISO 10993 standards (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, mutagenicity, hemocompatibility, intramuscular implantation).
- Animal study (porcine): Comparison of mechanical testing and local host responses between the two meshes for 90 days, with interim data at 30 days.
There is no mention of:
- Acceptance criteria related to AI performance or human reader performance.
- A test set of patient data, data provenance, ground truth establishment by experts, or adjudication methods for such data.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance or training set details.
The document's purpose is to show that the new surgical mesh is as safe and effective as an already cleared device based on material properties, degradation, biocompatibility, and animal (not human patient) study outcomes, which is typical for 510(k) submissions of this type of medical device.
In summary, the provided text does not contain information to answer the specific questions related to AI device evaluation, clinical study design for AI models, or human reader performance.
§ 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.