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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 One Well Dish is sterile, nonpyrogenic, embryotoxicity tested, singleuse 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 One Well Dish is sterile (SAL of 10-9, non-pyrogenic by Limulus Amebocyte Lysate (LAL of < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic dish diameter is 60-mm, the well area is 2.45 cm2, the well volume is 2.5 mL, and the total volume is 20 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 text describes a 510(k) submission for the FALCON® IVF One Well Dish. This document, however, focuses on regulatory approval and substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria in the manner typically associated with medical imaging or diagnostic AI devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set, ground truth methods) are not applicable to the information provided.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance:

The "acceptance criteria" for this device are primarily related to its manufacturing quality and safety for its intended use, rather than a quantifiable performance metric for accuracy or effectiveness in a clinical diagnostic sense. The text highlights the following characteristics:

Points that Cannot be extracted from the provided text:

• Sample sized used for the test set and the data provenance: Not applicable. This device is labware, not a diagnostic tool that relies on a test set of data. The "testing" refers to manufacturing quality control.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI device or a diagnostic device that human readers would use in conjunction with.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is established through standard laboratory testing for sterility, pyrogenicity, embryotoxicity, and material biocompatibility. For example, embryotoxicity is determined by the mouse embryotoxicity assay (MEA) 2-cell method.
• The sample size for the training set: Not applicable. This device does not use a training set as it's not based on machine learning or AI.
• How the ground truth for the training set was established: Not applicable.

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The FALCON® IVF Four Well Plate is sterile, nonpyrogenic, embryotoxicity tested, singleuse 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 Four Well Plate is sterile (SAL of 10%), non-pyrogenic by Limulus Amebocyte Lysate (LAL of < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic plate has four wells, each well area is 1.39 cm2 and each well volume is 1.8 mL. The plate has a unique lid which provides access to two wells at a time, while two remain covered. The wells are numbered and a large writing patch allows clear sample identification. Plates are packaged in individual peel-open trays for sterile presentation and are shipped in cases of 100 plates per case.

The plates 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 plates 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 text describes a 510(k) summary for the FALCON® IVF Four Well Plate, a medical device used in assisted reproduction. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text focuses on the device description, intended use, and substantial equivalence to a predicate device, as required for a 510(k) submission.

Based on the available information, here's what can be extracted and what cannot:

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

The document mentions several characteristics that serve as performance criteria for the device. These are inherent properties of the plate that ensure its suitability for IVF procedures.

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

The document does not specify the sample sizes used for testing each of the performance criteria (e.g., how many plates were tested for sterility, pyrogenicity, or embryotoxicity). It also does not provide details on data provenance (country of origin, retrospective/prospective).

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)

This information is not provided in the document. The tests performed (sterility, pyrogenicity, embryotoxicity) are typically laboratory-based assays with defined pass/fail criteria, rather than those requiring expert consensus for "ground truth" in the way clinical diagnostic devices might.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for human interpretation, not for validating the intrinsic properties of a labware device.

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

This is not applicable to the FALCON® IVF Four Well Plate. This device is labware, not an AI-assisted diagnostic tool.

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

This is not applicable to the FALCON® IVF Four Well Plate. It is not an algorithm-based device.

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

The "ground truth" for the performance criteria mentioned are established through validated laboratory assays and standards:

• Sterility: Measured by a Sterility Assurance Level (SAL) of 10⁻⁶, a standard microbiological test.
• Non-pyrogenicity: Measured by the Limulus Amebocyte Lysate (LAL) assay, a standard test for bacterial endotoxins.
• Non-embryotoxicity: Measured by the mouse embryotoxicity assay (MEA) 2-cell method, a standard biological assay using mouse embryos.
• Material properties: Compliance with USP Class IV, V, and VI cytotoxicity standards involves specific material testing protocols.

8. The sample size for the training set

This is not applicable. The device is labware, not a machine learning model requiring a training set.

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

This is not applicable.

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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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