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Oocyte Flushing & Retrieval Medium is intended for use during and oocyte collection procedures for use in in vitro fertilization procedures.

Gamete Buffer is indicated for use in short-term handling gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).

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I am sorry, but the provided FDA letter for Gimbo Medical Technology Shenzhen Co., Ltd. regarding K234023 does not contain the information needed to answer your request. The document is a 510(k) clearance letter for "Oocyte Flushing & Retrieval Medium; Gamete Buffer" and outlines regulatory information and indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies, which are typically found in a full submission or study report.

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 the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and any effect size
6. If a standalone performance (algorithm only) study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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