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Phosphate Buffered Saline With Cations and Phenol Red (PBSW) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).

Phosphate Buffered Saline (PBS) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).

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I am sorry, but this document is an FDA 510(k) clearance letter for a medical device (Phosphate Buffered Saline solutions) and does not contain the information requested about acceptance criteria, study details, or ground truth.

The document primarily focuses on:

• Confirming that the device, PBS and PBSW, is substantially equivalent to a legally marketed predicate device.
• Stating its indications for use (in vitro procedures like oocyte recovery, gamete washing, micromanipulation, embryo transfer, and cryopreservation).
• Providing regulatory information and contact details.

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

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone performance details
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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