(41 days)
SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and for reinforcement of gastric staple lines during bariatric surgical procedures of gastric bypass and gastric banding.
The 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 SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is to be used with surgical stapling devices.
The 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 document is a 510(k) summary for a medical device (SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material), not a study report for a diagnostic AI device. Therefore, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/diagnostic performance.
The document primarily focuses on establishing substantial equivalence to existing predicate devices based on device integrity testing rather than diagnostic performance metrics.
Specifically, it states:
"WL Gore & Associates, Inc. performed device integrity testing to support that the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is equivalent to the predicate devices. All device integrity test results for the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material met specified requirements."
This indicates that internal device integrity tests were conducted, and the results "met specified requirements." However, the document does not elaborate on:
- The specific acceptance criteria (e.g., numerical thresholds for sensitivity, specificity, accuracy, or other performance metrics).
- The detailed methodology of these "device integrity tests."
- Any quantitative performance metrics.
- Ethical statements found at the beginning of AI/Diagnostic studies.
- Statements about reproducibility of the study.
- Statements about the generalizability of results.
- Statements about bias.
- Statements about the impact of covariates such as age, gender, race, etc.
- Statements about the effect of dataset shift.
- Statements about the interpretability of AI models.
- Identification of which statistical endpoints are primary or secondary.
- Methods for statistical analysis.
- Approaches for handling missing data.
- Strategies for avoiding overfitting.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/diagnostic study design and results from the provided text. The document clearly states that "Performance standards do not currently exist for these devices. None established under Section 514." This further confirms the absence of a defined set of performance-based acceptance criteria in the context of the device's regulatory submission.
§ 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.