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The FALCON® IVF Round Dish is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.

The FALCON® IVF Round Dish is sterile, nonpyrogenic, embryotoxicity tested, single-use plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.

The FALCON® IVF Round Dish is sterile (SAL of 10.9), non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of

The provided document is a 510(k) summary for the FALCON® IVF Round Dish, a medical device for use in assisted reproduction. The information provided outlines the device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any data from a clinical or performance study to prove the device meets specific acceptance criteria.

The document primarily focuses on:

• Device Identification: Name, classification, and contact information.
• Substantial Equivalence: Claiming equivalence to existing devices based on regulatory reclassification.
• Device Characteristics: Describing it as sterile, non-pyrogenic, non-embryotoxic, made from specific materials, and with certain physical dimensions and features.
• Intended Use: For preparing, storing, manipulating, or transferring human gametes or embryos in IVF and other assisted reproduction procedures.
• FDA Clearance: The letter from the FDA confirming clearance based on substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria with reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided text.

Based on the nature of this 510(k) submission (which focuses on substantial equivalence for a labware device), a formal clinical trial with human subjects or a comparative effectiveness study with AI is highly unlikely to have been performed or required for this type of product clearance in 1999. The "studies" mentioned are laboratory tests to demonstrate sterility, non-pyrogenicity, and non-embryotoxicity, which are standard for this class of device.

Below is an outline of the types of information requested, with an explanation of why it cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided from the text. The document lists characteristics like "sterile (SAL of 10.9)," "non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of

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