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The Dream Sock analyzes photoplethysmography data to identify instances when the infant's pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant's PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.

The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level: rather, the feature is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The feature is not intended to replace traditional methods of monitoring, diagnosis or treatment.

The Dream Sock is not intended for use with infants previously diagnosed with cardiovascular or respiratory disease or conditions.

The Dream Sock uses photoplethysmography (PPG) on the infant's foot to measure the continuous pulse rate (PR) and oxygen saturation (SpO2) in the home environment. The device is intended to monitor healthy infants 1 to 18 months of age and between 6 to 30 lbs. The device includes alarms to alert the caregiver that the pulse rate or SpO2 has gone outside a preset range. The alarm thresholds are pulse rate 220 bpm and the SpO2

Here's a breakdown of the acceptance criteria and the studies proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

*   **Provenance:** Prospective, conducted in a home environment. Independent from the algorithm training set.

• NICU Study:
  • Sample Size: 66 patients (infants postmenstrual age $

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The BabySat 3 pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment

The Owlet BabySat 3 is a Pulse Oximeter for use in the home while the baby is resting or sleeping. The Sock secures the Sensor to the baby's foot. The Sensor measures the baby's readings (SpO2 and Pulse Rate) and transmits the baby's readings to the Base Station directly via Bluetooth. The Base Station monitors the baby's readings and will alarm if the readings are outside prescribed limits. The Base Station also relays the data to the App and to the Owlet servers. The Owlet BabySat 3 mobile device application displays the baby's readings.

The device is stand-alone and not part of a multiparameter module. The device is non-sterile, single patient use reusable and cleanable. The device is not reprocessed.

The BabySat 3 Pulse Oximeter is comprised of several components:

• Sock
• Sensor
• Base Station
• Mobile App

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: BabySat 3 (K222597)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for each clinical study (desaturation, signal quality/at-home, observational, human factors). However, it mentions:

• Desaturation Study: Included subjects across the "full Fitzpatrick Scale score."
• Signal Quality and At-Home Study: Covered a "full spectrum of evidence supporting the form factor of the Owlet device under review, accuracy related to the gold standard of arterial blood gas measurements, and accuracy in a real world, intended use population against a transfer standard." This implies a sufficiently diverse and representative sample.
• Observational Study: Conducted "in the intended population" for skin irritation.
• Provenance: The studies are clinical studies, implying prospective data collection for the specific device in question. No specific country of origin for the clinical data is mentioned, but the implication is data collected for the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts or their specific qualifications for establishing ground truth in any of the studies mentioned.

4. Adjudication Method for the Test Set

The document does not specify any adjudication methods (e.g., 2+1, 3+1) used for establishing ground truth in the clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, nor any effect size regarding human reader improvement with AI assistance. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool for interpretation by human readers.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies performed (desaturation, signal quality, accuracy measurements) represent the standalone performance of the device (algorithm and hardware) in automatically measuring and displaying SpO2 and pulse rate. The human factors study involved lay users, but the performance criteria like SpO2 and Pulse Rate accuracy are intrinsic to the device's measurement capabilities.

7. Type of Ground Truth Used

• SpO2 Accuracy: The ground truth for SpO2 accuracy in the desaturation study is implicitly stated to be the "gold standard of arterial blood gas measurements."
• Skin Irritation: Ground truth for skin irritation was established through observation for "clinically important skin reactions."
• Human Factors: Ground truth for human factors involved the "successful implementation of all critical tasks" by lay users.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for a training set. This device is a traditional pulse oximeter and not described as using a machine learning algorithm that requires a distinct "training set" in the sense of AI/ML development. Its performance is validated through traditional clinical and non-clinical testing.

9. How the Ground Truth for the Training Set was Established

As noted above, the document does not indicate the use of a "training set" for an AI/ML algorithm. Therefore, "how the ground truth for the training set was established" is not applicable based on the provided information.

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