(16 days)
The SPARC™ Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The SPARC™ Sling System is a sterile, single use procedure kit consisting of:
- Two stainless steel, curved, 22-cm long, needle passers (also called insertion ● tools).
- One piece of AMS Polypropylene sling mesh with attached dilating ● connectors. The AMS Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.0cm width x 50cm length. A fixed blue polypropylene anchoring suture runs through the middle of the sling mesh. Two plastic sheaths that overlap in the center of the sling mesh, cover the sling mesh and protect it during placement.
Dilating connectors are attached to either end of the plastic sheaths. The dilating connectors are used to attach to the vaginal ends of the SPARC™ needle passers during the procedure to facilitate sling placement. - Two blue colored plastic cystoscopy aids are included in the kit in order to ● facilitate cystoscopic viewing of the bladder. The use of these cystoscopy aids is optional.
The provided text is a 510(k) summary for the SPARC™ Sling System, a surgical mesh device. It details the device description, indications for use, comparison to a predicate device, and the FDA's substantial equivalence determination.
However, the document does not contain any information about acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.
The "Supporting Information" section briefly mentions: "A risk analysis of the proposed modification and bench test data reported in this 510(k) application substantiate equivalence to the predicate and did not raise any new questions of safety or effectiveness." This implies that some form of bench testing was conducted, but no details are provided regarding:
- Specific acceptance criteria
- Reported device performance values
- Sample sizes
- Ground truth establishment
- Expert involvement
- Adjudication methods
- Multi-reader multi-case studies
- Standalone algorithm performance (not applicable for a medical device that isn't AI/software)
- Training set information
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other study details based on the provided text. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against predefined acceptance criteria.
§ 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.