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The GORE SEAMGUARD® Staple Line Reinforcement Material for circular staplers is indicated for use in surgical procedures in which a soft tissue anastomosis with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.

This 510(k) is being submitted for a minor modification to the product configuration made to the SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material for use with circular staplers cleared under K053200. The proposed modification that is subject of this 510(k) submission is to include a polymer introducer sleeve as an accessory within the current packaging configuration for use as a tool to facilitate the delivery of the CBSG product through the abdominal wall to bariatric anastomotic sites during laparoscopic procedures. No other changes are being made to the SEAMGUARD device or its packaging as cleared under K053200.

The provided text is a 510(k) summary for a medical device modification, specifically for the GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with acceptance criteria and performance metrics as might be found in a Premarket Approval (PMA) application or a de novo submission.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance, or training set details).

The core of this 510(k) is to demonstrate that a minor modification (the inclusion of a polymer introducer sleeve) to an already cleared device does not raise new questions of safety or effectiveness. It relies on the substantial equivalence principle and states that "A variety of tests, assessments, and comparisons demonstrate that the SEAMGUARD® Staple Line Reinforcement Material with optional introducer sleeve for Circular Staplers is substantially equivalent to its predicate in terms of design, intended use, principle of operation, and performance attributes." However, these "tests, assessments, and comparisons" are not detailed in the provided text.

In summary, based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, device performance, and study methodology because this information is not present in a 510(k) summary for a minor device modification.

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The GORE SEAMGUARD Staple Line Reinforcement Material for Circular Staplers is indicated for use in surgical procedures in which a soft tissue anastomosis with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.

The GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material for circular staplers consists of a bioabsorbable membrane comprosed 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 SFAMGUARD® Bioabsorbable Staple Line Reinforcement Material is supplied in sterile polyethylene terphthalate / polyethylenc pouches. These pouches contain the necessary material for the cartridge jaw and the anvil jaw of the surgical stapler.

The provided text is a Premarket Notification 510(k) Summary for the GORE SEAMGUARD® Staple Line Reinforcement Material. This type of document is filed with the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.

It's important to understand that a 510(k) submission primarily focuses on substantial equivalence to an existing device, rather than proving that the device "meets acceptance criteria" in the way one might describe the performance of software or diagnostic AI. The "acceptance criteria" here largely revolve around demonstrating that the new device performs at least as well as and is chemically and physically equivalent to its predicate.

Therefore, many of the specific questions about acceptance criteria, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training sets – which are typical for AI/software device evaluation – are not applicable to this type of medical device submission. This submission is for a material (staple line reinforcement) and not a software or AI device.

However, I can extract the relevant information from the provided text in the spirit of your request:

1. A table of acceptance criteria and the reported device performance

For a material device like the GORE SEAMGUARD®, "acceptance criteria" are generally understood as demonstrating equivalence to the predicate device in terms of design, materials, and functional attributes. The document does not specify quantitative performance metrics as "acceptance criteria" in a table format, but rather relies on a general statement of substantial equivalence.

2. Sample sizes used for the test set and the data provenance

The document does not specify sample sizes for any "test set" or data provenance (e.g., country of origin, retrospective/prospective). Substantial equivalence for this type of device is typically established through a combination of engineering tests (e.g., material testing, mechanical strength), biocompatibility testing, and comparison of design features, rather than a clinical "test set" in the sense of patient data.

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

Not Applicable. This is a material device, not a diagnostic or AI device that relies on expert ground truth for performance evaluation in a "test set."

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

Not Applicable. See point 3.

5. 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 is a physical medical device, not an AI or software device. No MRMC study was mentioned or would be relevant.

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.

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

Not Applicable. See point 3. The "ground truth" for a device like this would be established through established engineering standards for material properties, biocompatibility, and functional performance in relevant models or in vitro tests. Clinical outcomes would be observed over time post-market, but aren't typically part of the 510(k) "ground truth" for demonstrating substantial equivalence.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

9. How the ground truth for the training set was established

Not Applicable. See point 8.

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The device is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using linear surgical staplers. The device can be used to reinforce staple lines during lung resections, abdominal and thoracic wall repairs, gastric banding, muscle flap reinforcement, repairs, vaginal prolanse, maluing il vaginal prolapse, pelvic floor reconstruction, urethral sling and diaphragmatic, femoral, incisional, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernial, The device may be used with anastomotic staplers and with non-anastomotic staplers.

Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve form. The sleeve is configured for use with commercially available linear surgical stapless

Here's an analysis of the provided text regarding the acceptance criteria and study for the SEAMGUARD™ Staple Line Reinforcement Material:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not explicitly stated as a numerical count, but it is implied that "tests conducted" involved multiple staples and material samples to derive mean values.
   • Data Provenance: The mechanical tests were conducted by the applicant (W.L. Gore and Associates). The country of origin of the data is not specified, but the applicant is based in the USA. The study appears to be a prospective mechanical testing study conducted in a lab setting, not a clinical trial withpatient data.

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

   • This question is not applicable in this context. The "ground truth" for the mechanical performance was established through physical measurements of staple failure force and material failure force, not through expert consensus or interpretation of medical images. For biocompatibility, the ground truth was based on the known properties of ePTFE and observations from animal studies.

3. Adjudication method for the test set:

   • Not applicable. As noted above, the "ground truth" was determined by direct physical measurement, not by expert review requiring adjudication.

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:

   • No. This is not a medical imaging device or an AI-enabled diagnostic tool. Therefore, an MRMC study is not relevant.

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

   • Not applicable. This is not an algorithm or an AI device. The device's performance was evaluated through direct mechanical testing in a standalone manner (the material itself was tested).

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

   • For mechanical performance: Directly measured physical properties (force required to cause staple straightening/failure and material tear/failure).
   • For biocompatibility: Established material properties (ePTFE's known biocompatibility) and observations from animal studies (histologic reactions).

7. The sample size for the training set:

   • Not applicable as this is not an AI/ML device requiring a training set. The "training" for this device would be its design and manufacturing process, optimized through engineering principles.

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

   • Not applicable, as there is no training set for an AI/ML model.

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