(216 days)
The Mosie Baby Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or choose not to conceive through intercourse, for semen collection and the delivery of semen or donor sperm to the vaginal canal. The Mosie Baby Kit should be used during the ovulatory phase of the menstrual cycle.
The Mosie Baby Kit is an over-the-counter (OTC) device intended for intravaginal insemination (IVI) at home. The Mosie Baby Kit includes the following components:
- Two Mosie syringes
- Two Mosie collection cups
- Instructions for Use.
Each component is single-use only and supplied non-sterile. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the sperm into the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally. The syringe features a rounded front end with a slotted tip opening. The syringe has a rounded stopper that fits within the rounded end of the syringe to aid in sperm delivery from the syringe to the vagina. The syringe also contains flanges designed to aid in device handling during use.
The provided text describes the regulatory clearance of the Mosie Baby Kit and includes summaries of non-clinical and clinical performance testing. However, it does not describe an AI/ML-driven medical device and therefore does not contain information related to multi-reader multi-case (MRMC) studies, ground truth establishment by experts, or the effect size of AI assistance.
The document primarily focuses on the physical and functional characteristics of a medical device (a home insemination kit) and regulatory requirements for its approval for over-the-counter use.
Based on the provided document, here's an attempt to answer the questions, highlighting where the information is not applicable to AI/ML devices:
Acceptance Criteria and Device Performance (Based on Mosie Baby Kit Document)
Since this is not an AI/ML device, the acceptance criteria are not in terms of AI model performance metrics like sensitivity, specificity, or AUC. Instead, they relate to the physical and functional properties of the device, as well as user comprehension and self-selection for an over-the-counter product.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Target) | Reported Device Performance |
|---|---|---|
| Shelf Life/Stability | Bioburden: | Met bioburden specifications for vaginal use in accordance with USP at baseline and end-of-shelf-life: |
- TAMC:
§ 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).