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For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Malleable catheter with distal side ports and a lumen which can accommodate a fiberoptic device to allow visualization of the interior of the uterus. Allows physician to confirm placement of insemination fluid in the uterine cavity.

The provided 510(k) Premarket Notification for the MedWorks Visualization Insemination Catheter does not include any acceptance criteria or a study proving the device meets said criteria.

Instead, the document explicitly states:

"Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Visualization Catheter are equivalent to those of the predicate devices."

Therefore, based on the provided text, none of the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader studies can be provided. This device's submission relied on demonstrating substantial equivalence to predicate devices without presenting new performance data.

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