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The SPARC™ Sling System is intended for the placement of a The SFARO - Oling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The SPARC™ Sling System as currently marketed 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 1.1 cm width x 50cm length. A fixed blue polypropylene tensioning 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.
• In K013355, 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 proposed device that is the subject of this 510k will not include the cystoscopy aids.

The provided text is a 510(k) summary for the SPARC™ Sling System, a surgical mesh, and a letter from the FDA stating substantial equivalence. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/algorithm performance. The device described is a physical surgical implant, not an AI-powered medical device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used for ground truth and qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

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