(369 days)
The Fertility Focus OvuSense Fertility Monitor (Fertility Focus OvuSense Fertility Monitor Starter Kit M009-US, which includes Reader M010-US and Personal Sensor M011) is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
The Fertility Focus OvuSense Fertility Monitor is intended for measuring and recording core body temperature intra-vaginally on a nightly basis during the non-menstruating phases of the monthly female reproductive cycle. The Fertility Focus OvuSense Fertility Monitor consists of two components made of silicone - a Personal Sensor, which collects the data, and a Reader (with LCD display), which establishes a communication link to the Personal Sensor whereupon the data is transferred to the Reader. Electromagnetic induction communications hardware transmits the stored temperature data from the Personal Sensor to the receiving device, the Reader, activated when the Sensor is placed on the Reader cradle and the Reader's dedicated download button is pressed. The microprocessor based Reader filters the overnight data, then calculates and stores the 25th percentile value, representative of the average basal (lowest) overnight temperature. The Reader then displays these nightly temperature readings on a graph using a relative scale - the kev information for necessary calculations being the temperature changes relative to other recorded temperatures within a cycle for a particular user, and not absolute temperature value. At the start of the next cycle, indicated by the User inputting first day of the bleeding in the cycle, the Reader algorithm calculates the date of ovulation in the prior cycle, and uses this to predict the fertile period for the cycle which has just started. The Reader then displays fertility information in a verbal summary, including: An indication of the day ovulation occurred in the prior cycle, or if ovulation was not detected it displays this information instead. An indication whether the cycle length was within the expected normal parameters.
Here's a summary of the acceptance criteria and the study details for the Fertility Focus OvuSense Fertility Monitor, based on the provided text:
Acceptance Criteria and Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining specific, quantifiable acceptance criteria. However, it does state an overall conclusion regarding the device's performance relative to the gold standard.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ovulation Detection | The OvuSense Fertility Monitor system provided a biological and statistically significant improvement in ovulation detection compared with the traditional method of oral temperature measurement. It demonstrated good linear agreement with the gold standard detection of ovulation using ultrasound and an improved 95% confidence interval for the agreement. |
| Safety & Effectiveness | The Fertility Focus OvuSense Fertility Monitor has been demonstrated to be as safe, as effective, and performs as well as or better than the predicates. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 19 women, measuring 81 cycles.
- Data Provenance: Prospective study. The country of origin is not explicitly stated, but the applicant and official correspondent are based in the UK and USA respectively, suggesting the study likely took place in one of these regions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that "ultrasound" was used as the gold standard for ovulation detection. It does not specify the number or qualifications of experts involved in interpreting the ultrasound results and establishing this ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method for the ground truth.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a standalone monitor for ovulation prediction, not an AI-assisted tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was conducted. The clinical investigation directly assessed the performance of the OvuSense Fertility Monitor system (algorithm only) in detecting ovulation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was ultrasound detection of ovulation ("gold standard detection of ovulation using ultrasound").
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The sample size for the training set:
- The text does not explicitly mention a separate "training set" or its sample size. The clinical investigation appears to be a validation study (test set) for the established algorithm.
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How the ground truth for the training set was established:
- Since a separate training set is not described, the method for establishing its ground truth is not provided. The algorithm's development or initial training phase is not detailed in this 510(k) summary.
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