(47 days)
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures.
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is also intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
The GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material consists of a bioabsorbable membrane formed into a sleeve with use of a polyester braided suture pullcord. The bioabsorbable material is comprised of a microporous structure of synthetic bioabsorbable glycolide and trimethylene carbonate copolymer. The GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is to be used with surgical stapling devices.
The GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is supplied in sterile, foil film laminate pouches. Pouches contain the necessary material for the cartridge jaw and the anvil jaw of the surgical stapler. Tyvek® inserts facilitate placement of the reinforcement material onto the stapler jaws.
The provided text is a 510(k) Premarket Notification for a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a study with the detailed information requested.
Therefore, the prompt's request for specific acceptance criteria, device performance tables, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance cannot be answered from the provided text.
The document does mention studies, but not in the format or with the detail required by the prompt's specific questions.
Here's what can be extracted from the provided text regarding studies:
Summary of Studies Mentioned:
- Type of Study: "In vivo studies"
- Purpose: To support the modification to the "Indication for Use" for specific surgical procedures (hysterectomy, liver resection, bladder reconstruction, bronchial, cardiac, esophagus, pancreas, and spleen).
- Conclusion: These studies, along with other data and information, were deemed sufficient to support a determination of substantial equivalence to predicate devices.
Why the requested information is not available:
- Acceptance Criteria/Performance Table: The 510(k) submission process for substantial equivalence does not typically require the establishment of, or reporting against, specific performance acceptance criteria in the way a PMA (Pre-Market Approval) might. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
- Sample Sizes (Test/Training): The document generally refers to "in vivo studies" without specifying sizes, whether they were test or training sets, or their provenance.
- Expert Ground Truth/Adjudication/MRMC/Standalone: These concepts are relevant to studies involving qualitative assessments, particularly in areas like imaging diagnostics or where expert review forms the basis of "truth." This device is a physical reinforcement material, so these types of studies are not applicable in terms of its primary function. The "ground truth" for its performance would likely be physiological outcomes, not expert interpretation of an image or data.
- Type of Ground Truth: While "in vivo studies" are mentioned, the specific nature of the "ground truth" (e.g., successful staple line reinforcement, reduction in complications) is not detailed.
In conclusion, the provided text does not contain the information necessary to complete the table or answer most of the specific questions about acceptance criteria and detailed study methodology. The 510(k) process relies on demonstrating equivalence rather than comprehensive performance against predefined, quantitative criteria.
§ 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.