(229 days)
The Nexo-Gide™ Bilayer Collagen Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
The Geistlich Nexo-Gide™ device, manufactured by Geistlich Pharma AG, is a resorbable collagen membrane of porcine origin, consisting of a compact smooth structure and of a porous structure that serves as an interface between the tendon and the surrounding tissues. Nexo-Gide™ Bilayer Collagen Membrane will be used as a tendon protector sheet that provides a nonconstricting, protective encasement for injured tendon, in the same manner as other tendon cover products like the predicate device TenoGlide (K053655, Integra Life Science).
The Nexo-Gide membrane is made of collagen type I and III without further cross-linking or chemical additives and is sterilized by gamma irradiation. The available sizes are 20x30mm, 30x40mm and 40x50 mm.
The provided text describes a medical device called Nexo-Gide™ Bilayer Collagen Membrane and its substantial equivalence determination to a predicate device, Tendon Wrap Tendon Protector (TenoGlide). However, the document does not describe a study involving an AI or algorithmic device that requires the detailed acceptance criteria and study information typically associated with such submissions (e.g., sample size, expert ground truth, MRMC study, training set details).
This document is a 510(k) summary for a physical medical device (a collagen membrane), not an AI/algorithm-based diagnostic or assistive device. Therefore, the questions related to AI/algorithm performance metrics, ground truth establishment by experts, MRMC studies, training set sizes, and data provenance in the context of an algorithm are not applicable to this submission.
The "Performance Data" section (Page 8-9) details bench testing and animal studies conducted to demonstrate that the Nexo-Gide membrane is substantially equivalent to its predicate.
Here's an attempt to extract relevant information from the provided text, while acknowledging that many of your questions are not applicable due to the nature of the device:
Device: Nexo-Gide™ Bilayer Collagen Membrane (a physical collagen membrane)
Purpose of Study/Submission: To demonstrate substantial equivalence to a predicate device (Tendon Wrap Tendon Protector) for the management and protection of tendon injuries.
Key Findings: The studies concluded that Nexo-Gide™ is substantially equivalent to the predicate device in terms of safety and effectiveness, despite differences in tissue source (porcine vs. bovine) and composition (Type I and III collagen vs. cross-linked Type I collagen and GAG).
1. Table of Acceptance Criteria and Reported Device Performance
The document describes pre-determined acceptance criteria for various bench tests and animal study outcomes, indicating that the device "passed" or "met all acceptance criteria" and demonstrated "similar performance." Specific numeric acceptance criteria are provided for mechanical properties.
| Characteristic | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Nexo-Gide™) |
|---|---|---|
| Physical Appearance | Beige collagen membrane | Almost white collagen membrane |
| Handling | Product is soft and conformable | Product is soft and conformable |
| Thickness | ≥ 0.2 mm | ≥ 0.2 mm |
| Porosity | Pores from 1 – 120 μm | Pores from 1 – 120 μm |
| Tensile Strength (maximal stress) | ≥ 0.06 MPa | ≥ 0.06 MPa |
| Stiffness (elasticity) |
§ 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.