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510(k) Data Aggregation
(363 days)
Ava Fertility Tracker
The Ava Fertility Tracker is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
The Ava Fertility Tracker aids women in ovulation prediction and to facilitate conception. The Ava Fertility Tracker is a non-invasive device made up of the following components:
The Ava bracelet incorporating hardware with electronics and embedded software
A mobile application running on smartphones (iOS and Android)
A backend server software, including algorithms running on remote servers
The Ava bracelet is worn by women at night and tracks the following physiological parameters with built-in sensors:
Temperature sensor - provides information on skin temperature
Photoplethysmography (PPG) sensor – measures the interbeat interval (IBI) providing information on pulse rate (HR), heart rate variability (HRV), breathing rate (BR) and perfusion. Only HR, HRV, and BR are used by the algorithms for prediction of the fertile window. Perfusion information is used to assess the quality of the PPG sensor data.
Accelerometer provides information on movement and sleep duration and phases
The user synchronizes the bracelet to the mobile app each morning. The mobile app receives the raw datasets via Bluetooth Low Energy (BLE) and transfers this data to the backend server. The algorithm is run on the physiological parameters collected and the prediction of ovulation and the fertile window is determined. This information is transferred and displayed in the mobile app. The mobile app will also display a single mean value for HR, temperature, HRV ratio, BR, and sleep duration from the prior night.
The mobile application has three modes:
Trying to Conceive Mode - The application shows the user the predicted day of ovulation plus five predicted fertile days leading up to the predicted day of ovulation. Users receive the prior night summary of measured parameters displayed in graphs. Users can track additional information on their cycle, such as sexual intercourse or cervical fluid (this information does not feed into the algorithm).
Cycle Tracking Mode– For users not wanting to conceive but wanting to track their cycle. These users receive the same information provided to Trying to Conceive Mode users.
Pregnancy Mode - Users receive the prior night summary of measured parameters displayed on graphs. They can also track additional information as relates to their pregnancy, such as their weight or their daily water intake. For each week of their pregnancy, a different piece of informational content gets displayed in the application, such as typical height and weight of a baby at this stage of their pregnancy.
Here's a breakdown of the acceptance criteria and study information for the Ava Fertility Tracker, based on the provided document:
Acceptance Criteria and Device Performance
| Test Name | Specification | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Transportation test | D.U.T. functional and no visual damage | Pass |
| Connector mating test | >1460 cycles | Pass |
| Battery Test 1 | Battery retains >50% capacity after 730 charging/discharging cycles | Pass |
| Battery Test 2 | Valid physiological data transferred to app after one night of data collection (at end of life with aged D.U.T.) | Pass |
| Cyclic strap elongation | Maximum 10% of straps break completely after 730 cycles of elongation and relaxation by 15% | Pass |
| Drop Test | D.U.T. functional and no visual damage after dropping from 1.5 m onto a hard surface (10 drops) | Pass |
| Shock test | D.U.T. functional and no visual damage after 15g acceleration applied (54 shocks) | Pass |
| Vibration test | D.U.T. functional and no visual damage after broad band random vibration excitation for 4.5h | Pass |
| Load Test | D.U.T. functional and no visual damage after 250N mechanical load for 1 hour | Pass |
| Perfume / insect repellent test | D.U.T. functional and no visual damage after 30-day exposure to perfume and insect repellent housing | Partial pass - Labeling to avoid exposure to ethanol-containing products. |
| Cosmetic cream test | D.U.T. functional and no visual damage after 30-day exposure to cosmetic cream housing | Pass |
| Sweat test | D.U.T. functional and no visual damage after 30-day exposure to artificial sweat housing | Pass |
| Temperature sensor validation | Precision: ± 0.2°C, Accuracy: ± 0.8°C (accelerated aging test) | Pass |
| Accelerometer sensor validation | Accuracy |
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