(141 days)
TYBR Collagen Gel 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 ligament.
TYBR Collagen Gel is a naturally-derived collagenous semi-permeable barrier device that conforms to the application site and degrades within 30 days. The TYBR Collagen Gel includes a blue color additive to aid with visualization. The applicator provides controlled delivery of the collagen gel to support uniform coverage at the desired location.
I'm sorry, but the provided FDA 510(k) Clearance Letter for TYBR Collagen Gel does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/software-based medical device.
The document describes a physical medical device (collagen gel) and its performance testing, which includes:
- Cadaveric simulated use testing: To assess biomechanical effects and risk of improper gel application (loading for tendon sliding and gliding).
- Animal performance studies (chicken flexor tendon repair model): To evaluate tendon rupture strength, histopathology, gross pathology (adhesion scoring), and range of motion compared to a predicate device.
This type of testing is relevant for a biomedical material, not for an AI device. The questions you've asked (about sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, etc.) are specific to the validation of AI/machine learning algorithms in medical imaging or diagnostics, which are not present in this document.
Therefore, I cannot extract the requested information 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.