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To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.

Preparing, storing and transferring human embryos. To be used only with the MIRI TL device.

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This document is a 510(k) clearance letter from the FDA for two devices: AT Medical MIRI TL and AT Medical CultureCoin. It does not contain information on device acceptance criteria or a study proving that the device meets such criteria. Therefore, I cannot fulfill your request with the provided information.

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The AT MEDICAL XQ-1 Incubator is intended to be used to provide an environment with controlled temperature at or near body temperature and CO2, O2, and N2 gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/ assisted reproduction technology (ART) treatments.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the AT Medical XO-1 device does not contain the detailed information necessary to answer your request.

Specifically, the document focuses on the regulatory clearance for the device, stating its intended use as an incubator for gametes and embryos during in vitro fertilization (IVF)/assisted reproduction technology (ART) treatments. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, it does not include:

• A table of acceptance criteria or specific reported device performance metrics.
• Details about a study that proves the device meets acceptance criteria, such as:
  • Sample sizes (test or training sets)
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • MRMC comparative effectiveness studies or effect sizes
  • Standalone algorithm performance
  • Type of ground truth used or how it was established.

This type of detailed study information is typically found in the full 510(k) submission, which is not provided here, or in associated clinical or validation reports, rather than the FDA clearance letter itself.

Ask a specific question about this device