(273 days)
Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.
Kerecis SecureMesh can be used for reinforcement of staple lines during:
- Bariatric surgical procedures
- Colorectal and Colon surgical procedures
- Gastric, small bowels and mesentery procedures
- Lung and bronchus resections
Subject Device is formed of intact acellular fish skin and is intended to be used as a staple line buttress with surgical staplers. The buttress material is supplied in a double pouch sterile packaging (EtO), where a pair of buttresses is provided on a pair of carriers to be used by a healthcare professional, to transfer the buttresses to the opposed jaws of a surgical stapler in the operating theatre prior to a stapling procedure. One pair of carrier and a buttress is used for each stapler firing.
The provided text is a 510(k) summary for the Kerecis SecureMesh, a surgical mesh. This document describes the device, its intended use, comparison with predicate devices, and performance testing to demonstrate substantial equivalence for regulatory clearance.
However, the questions you've asked are typically relevant to the development and validation of an AI/Machine Learning medical device, particularly concerning diagnostic or interpretative capabilities. The Kerecis SecureMesh is a physical surgical implant, not a software or AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test sets) do not apply to this medical device.
The document describes performance testing for a surgical mesh, which includes:
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Bench Testing:
- Biocompatibility (by leveraging prior testing on a similar product).
- Viral-inactivation evaluation (also leveraged from similar product).
- Tensile strength comparison with predicate.
- Usability (loading time, transfer to stapler, ease of use, force to fire, slippage).
- Performance (leak at staple line, leak pressure, seal burst).
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Animal Studies:
- An acute porcine ex-vivo study comparing the Subject Device to a predicate device and un-buttressed stapling (negative control). The conclusion was "no significant difference."
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Clinical Studies:
- "No clinical testing was included in this submission." This means no human clinical trials were performed for the 510(k) clearance based on substantial equivalence to predicate devices and the non-clinical testing.
Given the nature of the device and the provided text, I cannot answer the questions about AI/ML device validation. The "acceptance criteria" for this device would be established engineering and performance specifications, and the "proof" is the bench and animal testing demonstrating equivalence to a legally marketed predicate 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.