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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 < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic dishes have a diameter of 60-mm, well area of 24.07 cm², and well volume of 23.0 mL. The dish is sold in units of 20 dishes per bag, and 500 dishes per case.

The dishes have perfectly flat, optically clear surfaces for optimum manipulation and observation of the ova and embryos. The lids are designed for aseptic manipulation and consistent venting to maintain proper humidification. The dishes are manufactured from virgin crystalline polystyrene tested for USP Class IV, V, and VI cytotoxicity. and the surfaces are treated to provide a more wetable or hydrophilic surface for tissue culture.

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 < 20 EU/device)," and "nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method." These are performance claims based on standard lab tests, but the specific "acceptance criteria" (e.g., SAL must be 10^-6 or better) are not explicitly stated in a table format with corresponding reported values. No performance data related to clinical outcomes (e.g., IVF success rates) is presented using this device vs. others.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided from the text. The document describes laboratory tests (sterility, pyrogenicity, embryotoxicity) but does not provide details about the sample sizes used for these tests or the data provenance. These are typically internal quality control tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Cannot be provided from the text. This device is labware, not an AI or diagnostic device that requires expert ground truth for interpretation of images or other complex data. The "ground truth" for its performance would be derived from objective laboratory assays (e.g., microbial culture for sterility, LAL assay for pyrogenicity, MEA for embryotoxicity).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Cannot be provided from the text. As this device's performance relies on objective laboratory assays, adjudication methods related to human interpretation of outcomes are not relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a piece of labware for assisted reproduction, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness study would not be relevant or expected.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical labware device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Laboratory Assay Results. For sterility, non-pyrogenicity, and non-embryotoxicity, the "ground truth" would be established by the results of validated laboratory assays (e.g., the absence of microbial growth for sterility, LAL results within specification for non-pyrogenicity, and successful embryo development in the MEA for non-embryotoxicity). These are objective tests with predefined acceptance criteria, rather than subjective expert consensus or pathology.

8. The sample size for the training set

• Not applicable. This is a physical labware device and does not involve AI or machine learning models that require a "training set."

9. How the ground truth for the training set was established

• Not applicable. This is a physical labware device and does not involve AI or machine learning models that require a "training set" or its associated ground truth establishment.

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