(77 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 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):
| Acceptance Criterion (Inferred for 510(k) clearance) | Reported Device Performance (as demonstrated by 'in vivo' studies) |
|---|---|
| Substantial Equivalence to Predicate Devices: | "numerous similarities support a determination of substantial equivalence" to SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material (K030782) and GORE-TEX® Vascular Graft (K991683). |
| Safety & Effectiveness for Expanded Indications: | In vivo studies support the modification to the "Indication for Use" for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures. The device is deemed safe and effective for these uses, consistent with the predicates. |
Study Information (as applicable to a medical device 510(k) rather than AI/ML):
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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.