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The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid in the timing of intercourse by identifying those days in a woman's cycle on which intercourse is most likely to lead to conception via a urine test. The device consists of a software-controlled electronic monitor and urine test sticks. The consumer purchases this product through pharmacies and drug stores.

The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the CLEARPLAN EASY FERTILITY MONITOR which allows the information collected by this product to be transferred to and stored on a computer, and viewed on the computer display or printed out. The CLEARPLAN DATA TRANSFER SYSTEM also allows the time of access of the data to be recorded electronically and the data to be collated on the computer.

The target market for the CLEARPLAN DATA TRANSFER SYSTEM is women who have purchased the CLEARPLAN EASY FERTILITY MONITOR. The device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.

The CLEARPLAN DATA TRANSFER SYSTEM is intended to transfer data which have already been collected by the user of the CLEARPLAN EASY FERTILITY MONITOR. The information which is presented to the user of the device is analogous to that which they could have recorded on paper on a daily basis by noting the indications given by the MONITOR. It does not affect the interpretation of the results of the user's own activities. Therefore the CLEARPLAN DATA TRANSFER SYSTEM does not affect the scientific technology of the CLEARPLAN EASY FERTILITY MONITOR.

The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid in the timing of intercourse by identifying those days in a woman's cycle on which intercourse is most likely to lead to conception via a urine test. The device consists of a software-controlled electronic monitor and urine test sticks.

The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the CLEARPLAN EASY FERTILITY MONITOR which allows the information collected by this product to be transferred to and stored on a computer, and viewed on the computer display or printed out. The CLEARPLAN DATA TRANSFER SYSTEM also allows the time of access of the data to be recorded electronically and the data to be collated on the computer. The CLEARPLAN DATA TRANSFER SYSTEM consists of a software controlled electronic card reader, a connecting cable, electronic memory cards and user instructions.

I am sorry, but the provided document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Modification of Clearplan Easy Fertility Monitor" and its accessory, the "CLEARPLAN DATA TRANSFER SYSTEM."

It discusses the device's substantial equivalence to predicate devices and provides information on regulatory classifications and general controls. However, it does not include:

• Acceptance criteria or reported device performance for specific metrics.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, or ground truth details for either training or test sets.

Essentially, this document is a regulatory approval letter, not a scientific study report.

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The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy.

The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.

The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility.

CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.

CLEARPLAN FERTILITY EASY MONITOR will be labelled not for contraceptive use.

The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility. CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.

This is a Premarket Notification (510(k)) for the Clearplan Easy Fertility Monitor, indicating substantial equivalence to a predicate device. This document primarily focuses on regulatory approval and indications for use, without detailing specific performance studies or acceptance criteria for the device itself.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text. The document is a regulatory approval letter, not a detailed study report.

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