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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.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Animal Study):
  • Chicken Tendon Flexor Model: Not explicitly stated, but implies a "control article" (TenoGlide) for comparison. The study used a "chicken flexor tendon repair model."
  • Rat Achilles Tendon Study: The study used a "rat achilles tendon study." No specific number of animals is provided.
• Data Provenance: The animal studies were conducted to generate performance data for this submission. The origin of the animals (e.g., country) is not specified. They are inherently prospective studies as they were conducted to test the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not Applicable: This is a physical device, not an AI/algorithm. Ground truth was established via direct measurement in bench tests and histological/functional assessments in animal models, not through expert human interpretation of images for an algorithm.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this is a physical device. Outcomes were assessed objectively through measurements (bench testing) and biological/histological evaluations in animal models. No multi-reader adjudication process is mentioned or relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No: This is a physical device, not an AI-assisted diagnostic or workflow tool. Therefore, MRMC studies are not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable: This is a physical device. There is no algorithm.

7. The Type of Ground Truth Used

• Bench Testing: Quantitative measurements of physical properties (thickness, porosity, tensile strength, stiffness, suture pull-out forces), and qualitative assessment of appearance and integrity.
• Animal Studies:
  • Chicken Flexor Tendon Model: Histological evaluation of tissue reaction, functional assessment (WOF - presumably "Work Of Flexion" or similar mechanical outcome), assessment of tendon healing and adherence.
  • Rat Achilles Tendon Study: Assessment of degradation profile and local tissue effects (inflammation response).

8. The Sample Size for the Training Set

• Not Applicable: This is a physical device, not an AI/algorithm-based device that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not Applicable: As above, there is no training set for a physical device.

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