Search Results

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.

Ask a specific question about this device