(32 days)
The ULTRAPRO* Hernia System is intended for use in open repairs of abdominal wall hemia defects. This product is indicated for open repair of abdominal wall hernia defects
The proposed ULTRAPRO* Hernia System (UHS) is a sterile, pre-shaped, three-dimensional device constructed of an undyed onlay patch connected by a mesh cylinder to an underlay patch which is reinforced by a flat undyed absorbable film of Poliglecaprone-25 (MONOCRYL*). The underlay patch is marked with dyed polypropylene fibers to be clearly distinguishable from the onlay patch. The onlay patch, connector and underlay patch are manufactured from approximately equal parts of absorbable Poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. The polymer of the undyed and dyed polypropylene fibers (phthalocyanine blue, Color Index No. 74160) is identical to the material used for dyed/undyed PROLENE* suture material. Poliglecaprone-25 fiber consists of a copolymer containing glycolide and e-caprolactone. This copolymer is also used for MONOCRYL* suture material. After absorption of the Poliglecaprone-25 components only the polypropylene mesh remains. The structure and size of this remaining mesh are designed for the physiological stresses to which the abdominal wall is subject. The UHS is available in different sizes.
The provided text describes a 510(k) premarket notification for the ULTRAPRO* Hernia System, a Class II surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, performance studies, expert involvement, and ground truth establishment is not present in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no table of acceptance criteria or specific quantitative performance metrics reported in this document. The submission is focused on demonstrating substantial equivalence to predicate devices. The performance data section broadly states:
- Acceptance Criteria Mentioned: N/A (not applicable in this type of submission for specific performance targets)
- Reported Device Performance:
- "Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, with results demonstrating that the materials are acceptable for the intended use."
- "Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements."
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. This submission does not include a test set in the sense of a clinical or analytical performance study with a defined sample size for comparison against a ground truth. The "performance data" refers to biological and functional testing, not a dataset for evaluating an algorithm or diagnostic accuracy.
- Data Provenance: The document mentions "bench and animal testing," indicating experimental data, but does not provide specifics on the origin (e.g., country) for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This device is a surgical mesh; it does not involve establishing ground truth by expert review in the context of diagnostic or interpretive performance.
4. Adjudication Method for the Test Set:
- Not applicable.
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 not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used:
- Not applicable in the context of diagnostic accuracy. However, for the "biological reactivity" and "functional performance testing," the "ground truth" would be established by validated test methods (e.g., ISO standards, engineering specifications for functional requirements).
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary, the provided document is a 510(k) submission for a surgical mesh and therefore primarily relies on demonstrating equivalence to predicate devices and adherence to established material/functional testing standards rather than presenting data from clinical performance studies with specific acceptance criteria as would be seen for diagnostic or AI-powered devices.
§ 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.