(90 days)
ProLite Mesh and ProLite Ultra Mesh are intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material.
ProLite™ and ProLite Ultra™ Mesh are sterile, non-absorbable, knitted polypropylene monofilament mesh material. The ProLoop™ Mesh Plug is a non-absorbable, lightweight, pre-formed, three-dimensional plug constructed of knitted rows of monofilament polypropylene with multiple protruding monofilament loops. The devices are available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.
I am sorry, but based on the provided document, I cannot adequately answer your request. The document is a 510(k) summary for surgical mesh devices (ProLite Mesh, ProLite Ultra Mesh, and ProLoop Mesh Plug) and focuses on establishing substantial equivalence to previously cleared predicate devices.
Here's why I cannot provide the requested information:
- No Acceptance Criteria or Performance Study: The document explicitly states, "This submission does not contain technological changes for subject devices. ProLite, ProLite Ultra and ProLoop have the same technological characteristics as previously cleared ProLite Family devices (K930669 and K002093). The subject devices differ only from the predicate devices in the indications for use and contraindications in the labeling." This means no new performance studies were conducted or acceptance criteria defined for these specific devices in this submission because their core technology and performance are considered identical to their predicate devices. The submission focused on labeling changes.
- No Clinical Study Data: Consequently, there is no information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
This 510(k) is essentially seeking approval for updated labeling for existing devices, leveraging the prior approvals of the predicate devices. Therefore, the detailed study information you're asking for would likely be found in the original 510(k) submissions for the predicate devices (K930669 and K002093), not in this document.
§ 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.