(26 days)
GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement 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® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
The modified GORE® SEAMGUARD® Reinforcement possesses the same indications for use and fundamental scientific technology as the predicate GORE® SEAMGUARD® Reinforcement. The implantable device and loading carriers of the predicate GORE® SEAMGUARD® Reinforcement are being modified to permit the reinforcement material to be loaded onto the stapler and attach via adhesive-coated tabs that wrap around the side/back of the cartridge/anvil jaws of a surgical stapling device, in lieu of attaching a fully-coated device surface to the top surfaces of the cartridge/anvil jaws, to minimize the impact of the surface topography of surgical staplers in establishing compatible device fit. The implantable materials of the modified GORE® SEAMGUARD® Reinforcement and predicate GORE® SEAMGUARD® Reinforcement are the same bioabsorbable PGA:TMC. Both utilize the same bioabsorbable PLA:TMC adhesive to secure the device onto the jaws of a surgical stapler.
This document is a 510(k) premarket notification for a medical device (GORE® SEAMGUARD® Reinforcement), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details (sample sizes, ground truth, expert opinions, MRMC studies, standalone performance, training sets), and adjudication methods for an AI/ML device is not applicable here.
The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria using AI/ML methodology.
Here's what can be extracted from the document regarding the device's evaluation, framed in the context of the prompt's request, but clearly indicating the differences:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a list of specific, quantifiable acceptance criteria with corresponding numerical performance metrics as would be expected for an AI/ML device. Instead, the "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to a predicate device through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Deployment reliability under simulated use conditions. | "The tests demonstrated the performance of the modified GORE® SEAMGUARD® Reinforcement device is substantially equivalent to the predicate GORE® SEAMGUARD® Reinforcement device." (This broadly implies the modified device performed similarly well in deployment reliability as the predicate, meeting its established functional standards). |
| Substantial Equivalence (overall) in terms of: - Indications for Use - Design - Materials - Biocompatibility - Packaging - Sterilization - Labeling - Performance | "W.L. Gore & Associates concludes that the modified GORE® SEAMGUARD® Reinforcement device is substantially equivalent to the predicate GORE® SEAMGUARD® Reinforcement device in terms of indications for use, design, materials, biocompatibility, packaging, sterilization, labeling, and performance." (This is the overarching conclusion, indicating that all aspects were deemed sufficiently similar to the predicate.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated with a numerical value. The document mentions "deployment reliability testing under simulated use conditions," which implies testing on a sample of devices, but the number of devices or trials is not provided.
- Data Provenance: The "Pre-Clinical: Bench study" implies testing performed in a laboratory setting, likely within the manufacturer's facilities. It is a prospective test specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This type of information is typically relevant for studies involving human interpretation (e.g., radiology images). The testing described here is a bench study evaluating mechanical/functional performance, which does not involve "ground truth" established by experts in the context of a diagnostic interpretation.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a bench test for mechanical/functional performance (deployment reliability), no adjudication method (like 2+1 or 3+1 for expert discrepancies) is described or relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is for evaluating human reader performance, often with AI assistance (e.g., radiologists interpreting images). This device is a surgical reinforcement material, and its evaluation did not involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The "bench study" is analogous to a standalone functional test for the physical device.
7. The Type of Ground Truth Used:
- For the "deployment reliability testing," the "ground truth" would be the successful or unsuccessful deployment of the device as per pre-defined functional specifications, measured by objective metrics in a simulated environment. It is based on engineering specifications and direct observation of device function rather than expert consensus, pathology, or outcomes data in a diagnostic sense.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. There is no training set for this device.
§ 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.