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510(k) Data Aggregation
(58 days)
Solution for use during In Vitro fertilization procedures
Solution for rinsing of contact materials and for washing of the cervix. Not for culture.
Bicarbonate buffered salt solution. For use after pre-equilibration at +37℃ and 6% CO2.
The provided text is a 510(k) Premarket Notification Summary for the G-RINSE™ Assisted Reproduction Media. It does not contain a study that establishes acceptance criteria or reports device performance through experimental data or clinical trials.
The document primarily focuses on establishing substantial equivalence to a predicate device (ASPTM) based on similar technological characteristics and formulation changes to improve performance without raising new safety or effectiveness concerns.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details. These types of studies are not described in the provided text.
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