(363 days)
Not Found
No
The document mentions "algorithms" but does not explicitly state or provide evidence that these algorithms utilize AI or ML techniques. The description of the clinical study and performance metrics focuses on traditional statistical analysis and comparisons, not on the characteristics typically associated with AI/ML model evaluation (e.g., training/test sets, specific model types).
No
The device is intended for ovulation prediction to facilitate conception, which is a physiological process, not to treat or cure a disease or condition.
No
The device is intended to predict ovulation to facilitate conception, not to diagnose a disease or condition. While it measures physiological parameters, its purpose is to aid in family planning, not to provide a medical diagnosis.
No
The device description explicitly states that the Ava Fertility Tracker is made up of multiple components, including "The Ava bracelet incorporating hardware with electronics and embedded software". This indicates the device includes a physical hardware component with sensors, not just software.
Based on the provided information, the Ava Fertility Tracker is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Ava Fertility Tracker measures physiological parameters directly from the user's body (skin temperature, pulse rate, etc.) through external sensors worn on the wrist. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is to aid in ovulation prediction based on physiological measurements. While this information is related to a biological process, the device itself is not performing a test on a biological specimen.
The device falls under the category of a medical device that uses physiological data to provide information to the user. Its function is to track and analyze these parameters to predict ovulation, not to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
LHD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A single center, prospective clinical study was conducted to support the subject device. The study enrolled 66 women between the ages of 18 and 45 years of age that were not planning to become pregnant in the following three to six months. Also, the women enrolled in the study were not on hormonal birth control, breastfeeding or taking medications that could affect the menstrual cycle. They also did not have any health issues, frequently travel between time zones or have a sleeping disorder. The final analysis was performed on data from 61 women and 154 cycles.
Each woman in the study collected data in each cycle using subject device, Clearblue Digital Ovulation Test, and the Lady-Comp device (predicate).
The primary endpoint assessed the error in detecting the ovulation day using the Ava Fertility Tracker compared to urinary LH tests as a reference. In addition, the difference in the number of temperature shifts detected using basal-body temperature (Lady-Comp) compared to wrist skin temperature (Ava Fertility Tracker) was assessed as a secondary endpoint.
The study demonstrated that the Ava Fertility Tracker was able to accurately predict the day of ovulation. With a mean error of 0.315 days (95% Cl -0.029 to 0.698) the Ava Fertility Tracker was within the limits of the equivalence bounds of ±2 days, showing that the device can predict the time ovulation as compared to the LH reference test (p-value for equivalence
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
January 15, 2021
Ava AG Blathnaid Feldman Director Quality and Regulatory Affairs Gustrasse 73 Zürich 8055 Switzerland
Re: K200163 Trade/Device Name: Ava Fertility Tracker Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LHD Dated: December 4, 2020 Received: December 7, 2020
Dear Blathnaid Feldman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200163
Device Name Ava Fertility Tracker
Indications for Use (Describe)
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).
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
avaco
510(k) Summary K200163 Ava Fertility Tracker
| Date Prepared | January 14, 2020 |
|---|---|
| Applicant | Ava AG |
| Gutstrasse 73 | |
| CH-8055 Zurich | |
| Switzerland | |
| Contact Person | Agata Sroka, Senior Regulatory Affairs Manager |
| Agata.Sroka@avawomen.com | |
| US Contact Person | Stephen La Barbera, VP Marketing & Sales |
| Ava Science Inc. | |
| 77 Geary Street, 5th Floor | |
| San Francisco, CA 94108 | |
| USA | |
| Stephen.LaBarbera@avawomen.com | |
| Proprietary Name | Ava Fertility Tracker |
| Common Name | Proceptive Fertility Tracker |
| Device Classification | Unclassified |
| Product Code | LHD (Device, Fertility Diagnostic, Proceptive) |
| Predicate Device | Lady-Comp® USA (K050094) |
| The predicate device has not been subject to a design-related recall. | |
| Device Description | 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. |
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc. 77 Geary Street – 5th Floo San Francisco, CA 94108 United States
4
- 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.
- Indications for The Ava Fertility Tracker is intended to measure and display physiological Use 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).
Comparison of The table below includes a comparison of intended use and technological characteristics of the subject and predicate devices: Subject and Predicate Device Intended Use and Technological Characteristics
| Parameter | Subject Device
K200163
Ava Fertility Tracker | Predicate Device
K050094
Lady-Comp
Fertility Monitor | Comparison |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Ava Fertility
Tracker is intended to
measure and
display physiological
parameters (body
temperature, resting
pulse rate, heart rate
variability, and | Lady-Comp USA
is intended for
measuring and
recording basal
body temperature
(BBT) as an aid in
ovulation
prediction to
facilitate | Although there are
differences in the
indications for use
statements, the intended
uses for both devices are
the same (i.e., an aid in
ovulation prediction and to
facilitate conception). |
| | breathing rate) as an
aid in ovulation
prediction to facilitate
conception (not to be
used for
contraception). | conception (not to
be used for
contraception). | |
| General Design | Watch-style sensor
bracelet, phone app,
backend server | Oral temperature
sensor attached
to reader by a
cable | Different: The predicate
device has a temperature
sensor connected to a
reader loaded with the
prediction algorithm that
provides information on
the fertility status of the
user. The subject device
includes a wrist-worn
sensor that wirelessly
transmits data to an app
that connects to a server
where the fertility
algorithms analyze the
information collected and
transfer the prediction to
the app for display to the
user. These differences
do not raise different
questions of safety and
effectiveness (S&E). |
| Sensors | Temperature
PPG Sensor
Accelerometer | Temperature | Different: The subject
device includes additional
sensors to collect
additional information that
is used in by the fertility
prediction algorithm. The
addition of different
sensors does not raise
different questions of
S&E. |
| Parameters
Measured | Skin temperature
Resting pulse rate
Breathing rate
Heart rate variability
(HRV)
Sleep duration/ sleep
phases
Movement
Perfusion | Temperature | Different: The subject
device collects additional
physiological information
beyond that of the
predicate for use by the
fertility algorithm and for
data integrity purposes.
The collection of these
additional parameters
does not raise different
questions of S&E |
| Number of
Measurements
Taken | Periodically each night
while sleeping | Single
measurement
upon waking | Different: The subject
device collects data
throughout the night, while
the predicate is only used
once per day upon
waking. Collecting data
over a longer period does
not raise different
questions of S&E. |
| Location of
Temperature
Measurement | Wrist - skin | Oral | Different: The subject
device incorporates a
wrist-worn sensor, while |
| | | | |
| Temperature
Sensor
Accuracy/Precision | ±0.8°C/ ±0.2°C | ± 0.05°C/unknown | the predicate uses an oral
temperature probe. Use
of a wrist-worn sensor
does not raise different
questions of S&E.
Different: The accuracy
of the temperature sensor
is higher for the predicate
device than the subject
device. This difference
does not raise different
questions of S&E. |
| User Inputs | User can input:
• Period/flow
information
• Cervical fluid
consistency
• Sexual intercourse
• Pregnancy test
results
• Mood
• 10 user defined
functions | Not reported in
predicate 510(k)
Summary | Different: The specific
user inputs for the
predicate device are not
known. However, the
ability to input additional
information for tracking
does not raise different
questions of S&E. |
| User Interface | Smartphone app
showing graphical
display of the
fertility status (5-6
days)
• Fertile Days
• Ovulation day
• Additional
parameters
measured (e.g.,
HRV) for general
wellness
information
• User inputs | Per predicate
510(k) Summary
the user interacts
with the display
on the physical
device displaying
the measured
temperature. | Different: The subject
device provides
information via a
smartphone app, while the
predicate device displays
information on the screen
of the device. Differences
in user interfaces do not
raise different questions of
S&E. |
| Power Source | Rechargeable battery | Not reported in
predicate 510(k)
Summary | Different: Information on
the specific power sources
for the predicate device
are not known. However,
differences in in power
sources do not raise
different questions of
S&E. |
| Data Transmission
Method from
Sensor to Reader | Bluetooth Wireless
(wrist sensor to app
on phone)
Wi-Fi (phone to
backend server) | None | Different: The predicate
device transfers
information from the probe
to the reader using an
attached cable. The
subject device uses
wireless technology to
transfer information
between device
components. This
difference does not raise
different questions of S&E |
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
5
OVACO
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
6
Image /page/6/Picture/8 description: The image shows the word "avac" in a stylized font. The first three letters, "ava", are in black, while the last two letters, "co", are in a light purple color. The letters are connected and have a flowing, cursive appearance. The image is simple and clean, with a white background.
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
As shown in the table above, there are differences in the subject and predicate device indications for use statements. However, the intended uses of both devices are the same as they are both for aiding in ovulation prediction to facilitate conception and not to be used for contraception.
7
Image /page/7/Picture/1 description: The image shows a logo with the letters "AVACO" in a stylized font. The first three letters, "AVA," are in black, while the last two letters, "CO," are in a light purple color. The letters are connected and have a smooth, flowing design. The logo appears to be for a company or organization with the name AVACO.
The subject and predicate devices have different technological characteristics as shown in the table above. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Data
| Biocompatibility
Testing | Biocompatibility testing for the Ava Fertility Tracker device was conducted in
accordance with the 2020 FDA guidance document Use of International
Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process" as follows:
Cytotoxicity: ISO 10993-5:2009 Skin Irritation: ISO 10993-10:2010 Sensitization (Guinea Pig Maximization Model): ISO 10993-10:2010 Testing confirmed that the subject device materials are biocompatible. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software and
Cybersecurity | Software documentation provided in accordance with the 2005 FDA guidance
document Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices to support device software with a minor level of
concern.
Cybersecurity information provided in accordance with the 2014 FDA guidance
document Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices. |
| Electrical Safety
and EMC Testing | Electrical safety of the Ava Fertility Tracker was tested in accordance with:
AAMI/ANSI ES 60601-1:2005/A2:2010 (Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance) IEC 60601-1-11:2015 (Medical electrical equipment - Part 1-11: General
requirements for basic safety and essential performance -- Collateral
standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment) Photobiological safety was conducted in accordance with IEC 62471:2006
(Photobiological safety of lamps and lamp systems)
Battery testing conducted in accordance with IEC 62133-1:2012 (Secondary
cells and batteries containing alkaline or other non-acid electrolytes - Safety
requirements for portable sealed secondary cells, and for batteries made from
them, for use in portable applications)
Electromagnetic compatibility of the Ava Fertility Tracker was tested in
accordance with IEC 60601-1-2:2014 (Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance -- Collateral
standard: Electromagnetic compatibility - Requirements and tests) |
| Wireless
Technology | Wireless technology information provided in accordance with the 2013 FDA
guidance document Radio Frequency Wireless Technology in Medical Devices
Guidance for Industry and Food and Drug Administration Staff. |
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc. 77 Geary Street – 5th Floor San Francisco, CA 94108 United States
avawomen.com
8
Image /page/8/Picture/1 description: The image shows a logo with the letters "ava" in black and the letters "co" in purple. The letters are stylized and connected. The letters are all lowercase.
Performance
Testing - Bench
Bench testing shown in the table below was conducted to demonstrate that the Ava Fertility Tracker device meets its predetermined performance specifications.
| Test name | Summary | Specification | Pass / Fail |
|---|---|---|---|
| Transportation test | Drop test of | ||
| Device Under | |||
| Test (D.U.T.) in | |||
| transportation | |||
| box | D.U.T. functional | ||
| and no visual | |||
| damage | Pass | ||
| Connector | |||
| mating test | Check expected | ||
| mating cycles of | |||
| charging | |||
| connector within | |||
| component | |||
| specification | >1460 cycles | Pass | |
| Battery Test 1 | Lifetime test | ||
| after 730 | |||
| charging / | |||
| discharging | |||
| cycles | Battery retains |
50% capacity | Pass |
| Battery Test 2 | Sufficient battery
capacity at end
of life with aged
D.U.T. | Valid
physiological
data transferred
to app after one
night of data
collection | Pass |
| Cyclic strap
elongation | Cyclic elongation
of strap following
730 cycles of
elongation and
relaxation by
15% | Maximum 10%
of straps break
completely | Pass |
| Drop Test | Drop D.U.T.
from 1.5 m onto
hard surface (10
drops) | D.U.T. functional
and no visual
damage | Pass |
| Shock test | Acceleration of
15g is applied to
D.U.T. (54
shocks) | D.U.T. functional
and no visual
damage | Pass |
| Vibration test | Broad band
random vibration
excitation is
applied to D.U.T.
for 4.5h | D.U.T. functional
and no visual
damage | Pass |
| Load Test | Mechanical load
of 250N is
applied to D.U.T.
for 1 hour | D.U.T. functional
and no visual
damage | Pass |
| Perfume / insect
repellent test | Perfume and
insect repellent
applied to D.U.T. | D.U.T. functional
and no visual
damage | Partial pass -
Labeling to
avoid exposure |
| | housing (30-day
exposure) | | to ethanol-
containing
products |
| Cosmetic cream
test | Cosmetic cream
applied to D.U.T.
housing (30-day
exposure) | D.U.T. functional
and no visual
damage | Pass |
| Sweat test | Artificial sweat
applied to D.U.T.
housing (30-day
exposure) | D.U.T. functional
and no visual
damage | Pass |
| Temperature
sensor validation | Accelerated
aging test to
assess
temperature
sensor function
over time | The temperature
sensor chip
stays within
specification:
Precision:
$\pm$ 0.2°C
Accuracy:
$\pm$ 0.8°C | Pass |
| Accelerometer
sensor validation | Accelerated
aging test to
assess
accelerometer
function over
time | Accuracy $\lt\pm$
0.02 g
Precision $\lt\pm$
0.001g | Partial Pass –
Precision met at
all timepoints,
while accuracy
passed in aged
devices.
Justification
provided in
support of
precision as the
more important
factor as the
device only uses
relative
acceleration
changes that are
used in the
sleep state
computation. |
| PPG sensor
Validation | Assessed the
ability of the
device to
measure IBI,
HR, BR, and
HRV | PPG sensor
signal $\pm$ 3% error
for IBI and HR,
and $\lt$ 2.5%
signal error for
BR and HRV | Pass |
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
9
avo
Summary of Clinical Data
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Performance Testing - Clinical
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
A single center, prospective clinical study was conducted to support the subject device. The study enrolled 66 women between the ages of 18 and 45 years of age that were not planning to become pregnant in the following three to six months. Also, the women enrolled in the study were not on hormonal birth control, breastfeeding or taking medications that could affect the menstrual cycle. They also did not have any health issues, frequently travel between time
10
zones or have a sleeping disorder. The final analysis was performed on data from 61 women and 154 cycles.
Each woman in the study collected data in each cycle using subject device, Clearblue Digital Ovulation Test, and the Lady-Comp device (predicate).
The primary endpoint assessed the error in detecting the ovulation day using the Ava Fertility Tracker compared to urinary LH tests as a reference. In addition, the difference in the number of temperature shifts detected using basal-body temperature (Lady-Comp) compared to wrist skin temperature (Ava Fertility Tracker) was assessed as a secondary endpoint.
The study demonstrated that the Ava Fertility Tracker was able to accurately predict the day of ovulation. With a mean error of 0.315 days (95% Cl -0.029 to 0.698) the Ava Fertility Tracker was within the limits of the equivalence bounds of ±2 days, showing that the device can predict the time ovulation as compared to the LH reference test (p-value for equivalence