SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry

Pulse oximetry monitoring is considered a standard physiological measurement and is used by
clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is
a device that measures the oxygen saturation of arterial blood non-invasively.

The purpose of this study was to evaluate the SpO2 accuracy performance of the Owlet BabySat
v1.0 and Smart SockTM 2 pulse oximetry OSS v1.1 sensors during non-motion conditions over the
range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for a SpO2
validation.

The goal, in its entirety, was to show the SpO2 accuracy performance for the investigational
device Owlet Baby Care, Inc. Smart SockTM V. 2.

It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required
specification of ARMS 3% or lower in non-motion conditions for the range of 70 - 100% SaO2
thereby demonstrating an acceptable SpO2 accuracy performance specification.

No risks or adverse device effects were expected. There were no contraindications for use in
the proposed study population.

The study was conducted in accordance to the code of federal regulations for non-significant
risk medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable
sections of ISO80601-2-61 (1st edition 2011-04- 01), and Pulse Oximeters - Premarket
Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration
Staff (issued: March 4, 2013)

Inclusion Criteria:

- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance,
made up of either.

- Subject must have the ability to understand and provide written informed consent

- Subject is 18 to 50 years of age

- At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger

- Subject must be willing and able to comply with study procedures and duration

- Subject is a non-smoker or who have not smoked within 2 days prior to the study.

Exclusion Criteria:

- Subject is considered as being morbidly obese (defined as BMI >39.5)

- Compromised circulation, injury, or physical malformation of fingers, toes, hands,
ears or forehead/skull or other sensor sites which would limit the ability to test
sites needed for the study

- Females who are pregnant, who are trying to get pregnant

- Smoker Subjects who have refrained will be screened for COHb levels

- Subjects with known heart or cardiovascular conditions

- Subjects with known clotting disorders