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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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