(22 days)
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
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility (SAL) | 10⁻⁹ |
| Non-pyrogenic (LAL) |
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.