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Fertilité OV™ (PSC Fertility Monitor) is an over-the-counter ("OTC") in vitro diagnostic ("IVD") device intended for use by women as an aid in conception by measuring hormone-induced changes in the composition of the perspiration on the skin during the menstrual cycle. Properly used, it gives more notice for conceiving and is not invasive. It is NOT to be used for contraception.

The PSC Fertility Monitor consists of a small wristwatch that houses an interactive microprocessor and a biochemical sensor. The device measures chloride ion levels in female sweat from the skin surface in order to predict current fertility status by displaying the result on the screen. The device provides the user with notice up to four days before ovulation during which the user may have the greatest chance of becoming pregnant.

Here's an analysis of the acceptance criteria and study detailed for the PSC Fertility Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds). Instead, the performance is described in a comparative manner against existing methods.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 100 female research participants.
• Data Provenance: Prospective clinical study. The country of origin is not explicitly stated, but the submitter is based in Toronto, Ontario, Canada.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the text. The ground truth was established by clinical measurements rather than expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established by direct clinical measurements of serum LH levels, not by a panel of experts adjudicating interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compared different fertility monitors (devices measuring different parameters) against a common objective ground truth (serum LH levels), not different human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study evaluated the standalone performance of the PSC Fertility Monitor (and other monitors) directly against serum LH levels. This device is an "over-the-counter" device, implying it provides direct output to the user without a human expert interpreting the device's reading or interacting with an algorithm.

7. The Type of Ground Truth Used

The ground truth used was serum LH levels, which represents an objective clinical measurement.

8. The Sample Size for the Training Set

The text does not mention a separate training set or its sample size. The clinical study described appears to be a validation study for the device's performance. It's common for medical devices, particularly those involving biochemical measurements, to have algorithms or calibration developed prior to a clinical validation, but the details of any such training data are not included here.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not explicitly mentioned, the method for establishing its ground truth is not provided.

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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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The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.

The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques.

The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception.

After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.

The Ovulon Monitor is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.

The provided text is related to the FDA clearance of the Ovulon Monitor, a fertility aid. Unfortunately, the document is a 510(k) clearance letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document confirms the device's clearance based on substantial equivalence to pre-existing devices, but it does not detail the specific performance studies and their results.

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