Search Results

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.

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.

Ask a specific question about this device

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 subject GORE® SEAMGUARD® Reinforcement device is an assembly of three components: 1) the implantable device, 2) two (2) loading carriers (for anvil & cartridge side of stapling device), and 3) a protective cover. The implantable device consists of three layers - Web, Film, and Adhesive. The Web and Film layers are comprised of synthetic bioabsorbable polyglycolide (PGA) and trimethylene carbonate (TMC). A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device, and is composed of a synthetic bioabsorbable polylactide and trimethylene copolymer. The adhesive's function is to affix the device onto the surgical stapler for delivery to the implant site. The bioabsorbable copolymers degrade via a combination of hydrolytic and enzymatic pathways. The device is supplied sterile for single use only.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: GORE® SEAMGUARD® Reinforcement (K131658)

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not explicitly state a numerical sample size for the "simulated use performance testing" (bench study) or the "in vivo safety studies" (animal study). It mentions "testing" and "studies" in plural, implying multiple tests/animals, but no specific numbers are given.
• Data Provenance:
  • Bench Study: Not specified, but generally performed in a laboratory setting.
  • Animal Study: Animal data (in vivo). The country of origin for the studies is not specified. Both studies are prospective as they were conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is not provided in the summary. The evaluations appear to be objective measurements (e.g., performance metrics in bench testing, histological analysis in animal studies) rather than interpretations requiring expert consensus on a subjective ground truth.

4. Adjudication Method for the Test Set:

• Not applicable as the ground truth establishment method (if any) is not specified as requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This device is a medical implant (staple line reinforcement material), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Not applicable. This device is a passive implant; it does not involve any algorithms or AI to be evaluated for standalone performance.

7. The Type of Ground Truth Used:

• Bench Study: The "ground truth" for the simulated use performance testing would be objective measurements and observations of the device's functional characteristics (e.g., successful loading, secure attachment, integrity after stapling, comparison to predicate device performance specifications).
• Animal Study: The "ground truth" for biocompatibility and in vivo safety studies would be:
  • Biocompatibility: Conformance to ISO 10993-1 standards, which involve specific tests for cytotoxicity, sensitization, irritation, etc.
  • In Vivo Safety: Histological analysis of tissue response (e.g., inflammation, foreign body reaction) and clinical observation of device-related complications in animal models. The comparison was made to the predicate device's expected tissue response.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, no training set is involved for this type of medical device.

Ask a specific question about this device