(44 days)
The GORE POLYPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted Pholypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE® SOLYPROPYLENE HERNIA MESH may be used include, but are not limited to:
Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular).
Muscle flap reinforcement
The GORE POLYPROPYLENE HERNIA MESH is used as reinforcement during surgical repairs of hernias and other soft tissue deficiencies.
GORE POLYPROP YLENE HERNIA MESH is comprised of non-absorbable, knitted 100% polypropylene monofilaments. The GORE POLYPROPYLENE HERNIA MESH is provided STERILE for single use only and offered in several sizes and shapes to accommodate the type and approach of the operation.
The GORE POLYPROPYLENE HERNIA MESH will be supplied in sheets ranging from a rectangular configuration that is 2.5 x 10 cm to a rectangular configuration that is 25 x 35.5 cm. Also available is a pre-shaped oval configuration that is 6.5 x 13 CIII.
The GORE POLYPROPYLENE HERNIA MESH can be trimmed to the desired size and shape using sharp surgical scissors. The mesh should be sutured or tacked to host tissue avoiding excessive tension.
The provided text describes a 510(k) premarket notification for the GORE POLYPROPYLENE HERNIA MESH, which asserts substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies to establish safety and efficacy from scratch.
Therefore, the document does not contain specific acceptance criteria, a standalone study with detailed performance metrics, sample sizes, or information about expert adjudication, as would be expected for a de novo device approval or a clinical trial. Instead, it references "device integrity testing" to support equivalence.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The document indicates that "All device integrity test results for the GORE POLYPROPYLENE HERNIA MESH met specified requirements," but the specific requirements (acceptance criteria) themselves are not detailed.
- Reported Device Performance: Not explicitly detailed with specific metrics. The document only broadly states that the device "met specified requirements" in device integrity testing.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Adherence to "specified requirements" for device integrity testing (Implied) | All device integrity test results for the GORE POLYPROPYLENE HERNIA MESH met specified requirements (No specific metrics provided, only a general statement of compliance). |
| Equivalence to predicate devices in terms of comparable features, materials of construction, and intended use (Implied for 510(k) clearance) | "numerous similarities support a determination of substantial equivalence" to predicate devices (Bard® Mesh, Prolene™ Soft Polypropylene Mesh, Atrium Lite Mesh). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study is described as "device integrity testing," implying laboratory or bench testing, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This type of device integrity testing typically does not involve human experts establishing ground truth in the way a diagnostic AI might.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. Device integrity testing does not involve adjudication in the context of clinical agreement or diagnostic performance.
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:
- MRMC Study: No, this type of study was not conducted or mentioned. This is a physical medical device, not an AI-assisted diagnostic tool.
- Effect Size of AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Algorithm Only Standalone: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: For "device integrity testing," the "ground truth" would be the engineering specifications, material standards, and performance benchmarks against which the mesh's physical properties (e.g., tensile strength, pore size, biocompatibility) are measured and compared to the predicate devices. These are usually defined by industry standards, internal company specifications, or regulatory guidelines relevant to surgical meshes. The document does not explicitly state the specific ground truths, only that "device integrity testing" was performed and "met specified requirements."
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.