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510(k) Data Aggregation
(476 days)
DUOFERTILITY
The DuoFertility Monitor 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 DuoFertility system is a computerized basal body temperature thermometer with the following features:
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- A temperature Sensor with integrated data logger to monitor temperature throughout sleep and store the temperature readings
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- Measuring accuracy within +/- 0.05 deg C
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- Adhesive patches to hold the temperature Sensor against the users skin
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- Radiofrequency communications hardware to transmit the stored temperature data to a receiving device
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- Microprocessor based Reader to process and display temperature readings and fertility information.
The DuoFertility system is a computerized basal body temperature thermometer intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception.
Here's an analysis of its acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Temperature Measurement Accuracy: within +/- 0.05 degrees C | The tested Sensors were within the required specification of ±0.05 degrees C for each of accuracy, drift, and precision over a 24-hour period. |
| Electromagnetic Compatibility (EMC): Compliance with EN 60601-1-2:2002 and FCC 47 CFR 15 | The DuoFertility System passed all applicable EMC emissions and immunity tests required by EN 60601-1-2:2002 (IEC 60601-1-2:2001) and the FCC requirements defined in 47 CFR 15. |
| Electrical Safety: Compliance with EN 60601-1:1990 + Amendments | All safety tests passed (with 2 labeling issues corrected). |
| Biocompatibility: Safety for use in intended manner (ISO 10993) | All tests showed the DuoFertility sensor and adhesive materials to be safe for use in the intended manner (cytotoxicity, maximization sensitization, and primary skin irritation). |
| Software Verification: Compliance with Software Requirements Specification | Software verification testing has demonstrated that the sensor, reader, PC, and server software comply with the requirements of the Software Requirements Specification. |
| Clinical Performance (Ovulation Prediction): At least equivalent to predicate device | Analysis of data from 21 menstrual cycles demonstrated that the DuoFertility monitor is at least equivalent in performance to the Lady-Comp predicate device for the purpose of identifying the date of ovulation. The study also provided evidence that users are able to follow instructions and use the device as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set Sample Size: Data from 21 menstrual cycles was analyzed. The number of individual subjects is not explicitly stated, but it would be at least 21 women if each provided only one cycle, or fewer women if some provided multiple cycles.
- Data Provenance: The data was collected through a prospective clinical study. The country of origin is not explicitly stated for the clinical study, but the submitter (Cambridge Temperature Concepts Ltd) is based in the United Kingdom.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the clinical test set. The comparison was made against a predicate device (Lady-Comp), implying that the "ground truth" for ovulation prediction was derived from the performance of the predicate device, or implicitly, from the accepted method of BBT interpretation for ovulation as performed by both devices.
4. Adjudication Method
No adjudication method is described for the clinical test set. The "ground truth" for comparison was the performance of the predicate device, Lady-Comp.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. This device is a direct measurement and interpretation system, not an AI-assisted diagnostic aid that human readers would use. The clinical study compared the device's performance to a predicate device, not human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done for the device's core functionality. The "Clinical tests" section describes the device comparing its temperature readings and derived ovulation prediction to a predicate device (Lady-Comp) without human intervention in the interpretation process of the DuoFertility system itself beyond the initial instructions for use. The device itself is designed to process and display fertility information.
7. Type of Ground Truth Used
- For temperature measurement accuracy, the ground truth was "known temperatures, by immersion in a calibrated, computer-controlled waterbath."
- For clinical performance (ovulation prediction), the performance of the Lady-Comp predicate device served as the comparative "ground truth." The study evaluated if DuoFertility was "at least equivalent in performance" to Lady-Comp.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This suggests that the device's algorithm for ovulation prediction might be based on established physiological models of BBT, or if any machine learning was used, the training data details are not provided in this summary.
9. How Ground Truth for the Training Set Was Established
As no training set is described for a machine learning model, there is no information on how its ground truth was established. The device likely relies on conventional BBT interpretation rules rather than a learned model requiring a distinct training set with established ground truth.
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