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The 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 for open staplers consists of a bioabsorbable membrane comprosed of a microporous structure of synthetic bioabsorbable glycolide and trimethylenc 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 polyethylene terphthalate / polyethylene pouches. These pouches contain the necessary material for the cartridge jaw and the anvil jaw of the surgical stapler.

This is a 510(k) premarket notification for a medical device (Staple Line Reinforcement Material), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, are not present in this document.

The document states that the device is "substantially equivalent" to a predicate device based on "A variety of tests, assessments, and comparisons" in terms of "composition, design, intended use, mode of operation and performance attributes." However, it does not provide specific details about these tests, the acceptance criteria, or the reported performance outcomes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or address the other points related to AI/ML device validation.

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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.

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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 lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

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.

Attached is an analysis of the provided text regarding the GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material.

Acceptance Criteria and Device Performance:

The provided document (K032865) does not explicitly list quantitative acceptance criteria in a table format alongside specific device performance metrics in the way one would typically expect for a software or AI/ML device. This is a 510(k) premarket notification for a medical device (surgical mesh), not an AI/ML diagnostic tool. Therefore, the "acceptance criteria" here refer to the demonstration of substantial equivalence to a predicate device, as required for 510(k) clearance, rather than performance against predetermined statistical thresholds for accuracy, sensitivity, or specificity.

The document states: "Performance standards do not currently exist for these devices. None established under Section 514." This confirms that there are no formal performance standards or acceptance criteria defined by a recognized body for this type of device at the time of clearance.

The study presented is an in vivo study demonstrating the expansion of the device's "Indication for Use" statement, concluding that the device is substantially equivalent to existing predicate devices.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) process):

Study Information (as applicable to a medical device 510(k) rather than AI/ML):

1. Sample size used for the test set and the data provenance:

   • The document mentions "In vivo studies" but does not specify the sample size (e.g., number of animals or human subjects) used in these studies.
   • Data provenance: Not explicitly stated, but "In vivo studies" typically refer to animal studies or potentially human clinical data. Given the context of a 510(k) for a material, it's highly likely to be animal studies focusing on biocompatibility, integrity, and performance in relevant anatomical locations. It is retrospective as it is a premarket notification, referencing studies already completed. Geographic origin is not stated, but given WL Gore & Associates is based in Flagstaff, AZ, USA, it's likely U.S.-based or conducted under applicable U.S. regulatory standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of this 510(k) for a medical device material. "Ground truth" as understood in AI/ML (e.g., expert consensus on images) is not a concept applied here. Device performance is assessed through material properties, in vivo biological response, and mechanical integrity, which are evaluated by engineers, pathologists, and surgeons/veterinarians involved in the in vivo studies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This concept pertains to resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant for this type of medical device clearance.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This type of study design is specifically for evaluating the impact of AI on human reader performance, which doesn't apply to a bioabsorbable staple line reinforcement material.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a physical medical implant, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the in vivo studies, the "ground truth" would be established through direct observation during surgery, histological/pathological examination of tissue samples, and potentially necropsy results for animal models. Clinical outcomes data (e.g., incidence of leakage, bleeding, healing rates) would also contribute to the understanding of device performance in a functional context.

7. The sample size for the training set:

   • Not applicable. This refers to AI/ML model training data. For a physical device, prior research, and manufacturing/testing data inform its design and expected performance, but there isn't a "training set" in the AI sense.

8. How the ground truth for the training set was established:

   • Not applicable. As above, this is for AI/ML models. For this device, in vitro material testing, initial animal studies, and engineering principles guide the device development and manufacturing processes.

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