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GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery.

Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include:

-Hernia repair as suture line reinforcement

-Muscle flap reinforcement

-General tissue reconstructions

The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web structure that functions as a surgical mesh for soft tissue reinforcement while providing a scaffold for tissue ingrowth. It is used to reinforce soft tissue during the phases of wound healing by filling soft tissue deficits. The device elicits a physiologic tissue response which fills the deficit with native tissue and gradually absorbs the device. The implanted GORE® BIO-A® Tissue Reinforcement is a textured porous fibrous web surface on both surfaces composed solely of synthetic bioabsorbable poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC). In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months. The GORE® BIO-A® Tissue Reinforcement is available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The device is sterilized by gamma irradiation validated to an SAL of 10°. It is for single use only.

I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain the information needed to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The 510(k) submission for the GORE BIO-A Tissue Reinforcement, K191773, explicitly states:

• "No bench, animal, or clinical studies were required to support the labeling modification." (Page 4, under "Summary of Performance Testing")
• The entire submission is focused on a "labeling change that is not related to any safety or effectiveness issue" and clarifies that there are "no differences in technological characteristics between the subject and predicate device." (Page 4, under "Differences in Technological Characteristics")

Therefore, the document does not discuss:

1. A table of acceptance criteria or reported device performance from a new study.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Types of ground truth used.
8. Sample size for training sets.
9. How ground truth for training sets was established.

This is a regulatory clearance for a labeling change only, implying that the device itself was previously cleared or is substantially equivalent to a cleared predicate, and no new performance data was submitted or required for this specific 510(k) application.

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GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery.

Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include: -Hernia repair as suture line reinforcement -Muscle flap reinforcement -General tissue reconstructions

The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web structure that functions as a surgical mesh for soft tissue reinforcement while providing a scaffold for tissue ingrowth. It is used to reinforce soft tissue during the phases of wound healing by filling soft tissue deficits. It elicits a physiologic tissue response which fills the deficit with native tissue and gradually absorbs the device. The implanted GORE® BIO-A® Tissue Reinforcement is a porous, fibrous flat sheet web structure composed solely of synthetic bioabsorbable polyglycolide / trimethylene carbonate copolymer. In vivo studies indicate the bioabsorption process should be complete by six to seven months. The device is available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The device is sterilized by gamma irradiation validated to an SAL of 10-6. It is for single use only.

The provided document is a 510(k) premarket notification for a medical device called "GORE BIO-A Tissue Reinforcement," which is a surgical mesh. This document does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it discusses the substantial equivalence of a bioabsorbable surgical mesh to previously marketed predicate devices.

Therefore, I cannot extract the information required to populate the fields related to an AI/Machine Learning device study, such as

• A table of acceptance criteria and the reported device performance (for an AI/ML device)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance (algorithm only)
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document explicitly states: "No bench or clinical testing was used to support this 510(k) premarket notification. The animal study presented in this submission demonstrated equivalent performance when comparing Gore's synthetic PGA:TMC scaffold to a Cook's SIS collagen-based scaffold structure."

This indicates that the device's substantial equivalence was demonstrated through comparison to predicates and an animal study, not through a performance study against acceptance criteria for an AI/ML algorithm.

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