(233 days)
The Soules Intrauterine Insemination Catheter is used to access the uterine cavity for saline infusion sonohysterography or for the introduction of washed spermatozoa into the uterine cavity.
The Soules Intrauterine Insemination Catheter consists of a 5.3 French polyethylene catheter that is 25 cm in length with a polyethylene female luer adapter hub. The tip of the device features an oval side port located ~2.5 mm from the distal end of the catheter. A 3 mm movable silicone positioner is also present on the shaft of the catheter that can be adjusted to aid in positioning the device to the targeted depth within the uterine cavity during a procedure.
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered medical device. The document is a 510(k) summary for a Soules Intrauterine Insemination Catheter, which is a physical medical device, not an AI/ML device.
Therefore, I cannot provide a response based on the requested categories such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, and how ground truth for training set was established. These categories are relevant to AI/ML device studies, not the type of device described in the document.
The document does mention some performance testing for the physical catheter, but it does not fit the format requested for an AI/ML device.
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).