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The BioBridge™ Collagen Matrix is intended to reinforce soft tissue where weakness and deficiencies exist, specifically, for reinforcement of soft tissue repaired by suture anchors in tendon repair, including small tendons, ligaments, and general surgical procedures for tissue repair where weakness exists, including muscle flap reinforcement.

BioBridge is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair.

BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen that is designed to provide mechanical support for weaknesses and deficiencies in soft tissue. The collapsed ribbon structure contains multiple folds of a thin membrane with aligned collagen fibrils in the same lengthwise direction. This structure provides mechanical properties that contribute to strong tensile strength, that which provides support to weaknesses and deficiencies in soft tissue and aids in bridging a connection between two healthy soft tissues.

BioBridge is fabricated using a proprietary manufacturing process that produces a narrow and very thin ribbon-like membrane comprised of collagen fibrils, creating a multiluminal structure that provides mechanical properties for support of soft tissue repair. This approach presents the opportunity to enable the use of highly purified, pepsin treated collagen, in a defined structure that has mechanical properties similar to those of the predicates. The smaller ribbon-like form factor gives the surgeon greater flexibility to tailor their procedures compared to the predicates without changing the intended use. One or more BioBridge devices can be implanted depending on the surgeon's discretion, including arrangement of the individual devices in bundles or braided together by the physician, to better address a specific patient need. It is particularly well suited, for example, in supporting repair of small tendons and ligaments. Fibralign sources the highly purified porcine-derived Type I collagen from an FDA-registered and ISOqualified supplier. Fibralign employs a proprietary manufacturing process that takes highly purified porcine-derived Type I collagen and produces narrow, ribbon-like membranes comprised of highly aligned collagen fibrils that provides mechanical strength for use in supporting soft tissue. A chemical crosslinking agent is used during the manufacturing process to promote the crosslinking of the collagen but the crosslinker itself is not added to nor bound to the collagen matrix. The crosslinker residuals are water soluble and are removed by product rinsing at the end of the production process. The final product is packaged into individual storage containers and then sealed within an outer tray and terminally sterilized.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the "BioBridge Collagen Matrix."

The provided text, which appears to be an FDA 510(k) summary, does not contain specific acceptance criteria, performance metrics with numerical values, or detailed study results in a format that would allow me to construct the requested table or answer the detailed questions about sample sizes, ground truth establishment, or expert qualifications.

While the document lists various nonclinical tests performed (e.g., Dry Tensile Pull Test, Wet Tensile Pull Test, Biocompatibility testing, in vivo studies), it does not provide the quantitative acceptance criteria for these tests nor the actual reported device performance values against those criteria. It also states that "This section is not applicable as the 510(k) clearance of this device was not supported by clinical testing," which means there would be no information on human reader studies (MRMC or standalone AI performance).

Therefore, with the information given, I cannot generate the specific details you've asked for.

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