Search Results
Found 2 results
510(k) Data Aggregation
(329 days)
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 <50 or >220 bpm and the SpO2<80%. The device calculates the outputs during times of motion and non-motion. The device includes 3 components: the sock hardware, the base station and mobile application. The wearable connects to the base station via Bluetooth (BLE).
The Sock is the skin-contacting component that contains the PPG sensor and accelerometer. The accelerometer is used in signal quality algorithm. If too much motion is detected, then no measurement will be output. The PR and SpO2 algorithms are housed on the Sock. The algorithm uses a 10 second rolling window of the PPG data to calculate a measurement every second. The Sock communicates with the Base station using Bluetooth.
The Base Station receives the readings and status from the sensor. When the PR and/or SpO2 measurement goes outside the preset threshold(s), a visual and auditory alarm will sound alerting the caregiver. When the caregiver acknowledges the alarm, the top of the base station is clicked to silence the alarm. The base station communicates with the Cloud which communicates with the phone application through WIFI. Additionally, this is used to charge the sensor.
The mobile application displays the measurements and trend graphs of previous data. A new measurement is displayed every 5 seconds on the mobile application. If the base station alarms. the mobile application will display a notification.
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
| Test Category | Specific Test/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility/Materials | Cytotoxicity | Grade $\le$ 2 | PASS at 1:8 dilution |
| Sensitization | No evidence of tissue reaction | PASS | |
| Irritation | No evidence of tissue irritation | PASS | |
| Acute Systemic Toxicity | No unscheduled deaths; no weight loss >10% | PASS | |
| Material Mediated Pyrogenicity | Animals survive and are healthy via temperature monitoring | PASS | |
| Electromagnetic & Electrical | Essential Performance | Conforms to IEC 60601-1-2:2014, IEC 60601-1:2006 + A1:2013, ASNI C63.27:2017, AAMI TIR69:2017, IEC 60601-1-11:2015/AMD1:2020 | Conforms to all listed standards |
| Software | Validation (Major LOC) | Appropriate documentation provided to support validation in accordance with FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," (issued May 11, 2005) | Documentation provided and accepted for Major LOC |
| Performance Testing - Bench | Pulse Amplitude (PA) Accuracy | $\le$(b)% ARMS AND As the simulator PA rises from (b)%, the $\Delta$PR $\le$ 1bpm & Simulator PA $\Delta$SpO2 (b)% $\le$ PA $\le$ (b)% (b)% $\le$ PA < (b)% $\le$ (b)% (Specific numerical values for (b) are redacted in the provided text.) | PASS (Specific numerical values for the reported performance are not provided, but it states "PASS") |
| Pulse Rate Accuracy | $A_{RMS} \le$ 1 bpm | PASS | |
| Alarm Testing | Functionality works as intended (per 60601-1-8:2006+ AMD1:2012+AMD2:2020) | PASS | |
| Clinical Performance | SpO2 Accuracy (Breathe-down) | RMS < 3% (for both non-motion and motion) | Non-motion RMS: 2.51% Motion RMS: 2.46% (Meets criteria) |
| Pulse Rate Accuracy (Breathe-down) | RMS < 5 bpm (for both non-motion and motion) | Non-motion RMS: 2.47 bpm Motion RMS: 2.54 bpm (Meets criteria) | |
| SpO2 Accuracy (At-Home Study) | (Implicit: Demonstrate acceptable accuracy for SpO2 in intended use population) | Average Root Mean Square (Ams) of 2.16% (This is a performance result, and while not an explicit "acceptance criteria" value, it shows the device's accuracy in the intended environment, implicitly meeting the expectation for clinical performance.) | |
| Pulse Rate Accuracy (At-Home Study) | (Implicit: Demonstrate acceptable accuracy for PR in intended use population) | Average Root Mean Square (Ams) of 3.53 bpm (Similar to SpO2, this is a performance result indicating acceptable accuracy.) | |
| Alarm Specificity (Bradycardia) | (Implicit: High specificity to minimize false positives) | 100% (High specificity indicates very low false positives, meeting an implied acceptance criterion for alarm reliability.) | |
| Alarm Specificity (Oxygen Desaturation) | (Implicit: High specificity to minimize false positives) | 99.86% (High specificity indicates very low false positives, meeting an implied acceptance criterion for alarm reliability.) | |
| Skin Irritation | Low rate and low severity of skin reactions (Implicit criterion based on biocompatibility and safety.) | Estimated rate of reactions per person per week of 0.16 (95% CI 0.01, 0.40). All skin reactions were severity 1 (Slight indentation or mild color change). (Meets implicit criterion for low rate and severity.) | |
| Human Factors/Usability | Caregiver Use & Interpretation | Caregiver can correctly use the device based solely on reading the labeling and correctly interpret outputs and understand next steps. | All subjects responded to critical tasks by responding to the infant upon annunciation of notification events. Correct response included assessing the infant's condition and correcting the root cause of the notification. (Meets criterion for correct use and response.) |
2. Sample Size for the Test Set and Data Provenance
- Breathe-down Study:
- Sample Size: 18 healthy adults
- Provenance: Prospective, conducted in a controlled environment (likely a lab/clinical setting) with induced lower SpO2. "invasive pulse oximetry and the Masimo pulse oximeter" used as reference.
- At-Home Study:
- Sample Size: 35 subjects (infants between post menstrual age $> $44 weeks and $\ge$ 18 months, weighing 6-30 lbs)
- Provenance: Prospective, conducted in a home environment. Independent from the algorithm training set.
- NICU Study:
- Sample Size: 66 patients (infants postmenstrual age $< $44 weeks)
- Provenance: Prospective, single-center clinical study conducted in a Neonatal Intensive Care Unit (NICU).
- Skin Observation Study:
- Sample Size: 43 participants (infants with an average age of 7.0 $\pm$ 4.7 months). 30 wore the device for $\ge$ 48 hours.
- Provenance: Prospective study.
- Usability Testing:
- Sample Size: 20 participants (lay caregivers)
- Provenance: Conducted in a simulated-use environment.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number or specific qualifications of experts used to establish a "ground truth" for the test sets in the typical sense of expert annotation for machine learning.
- For the Breathe-down Study, an "invasive pulse oximetry and the Masimo pulse oximeter" served as reference devices for SpO2 and Pulse Rate measurements.
- For the NICU Study, "hospital grade pulse oximeters and electrocardiogram (ECG)" were used as continuous monitoring references.
- For the Skin Observation Study, the skin inspections were likely performed by trained medical personnel, though their specific qualifications or number are not detailed.
4. Adjudication Method for the Test Set
The provided text does not mention any formal adjudication methods (like 2+1 or 3+1) for establishing ground truth for the test sets. The ground truth seems to be established through:
- Comparison against established reference medical devices (invasive pulse oximetry, Masimo pulse oximeter, hospital-grade pulse oximeters, ECG).
- Direct observation for events like skin irritation.
- Observation of user actions in usability testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was mentioned or conducted, as this device is a direct monitoring device and not an AI-assisted diagnostic tool for human interpretation.
6. Standalone (Algorithm Only) Performance
Yes, standalone (algorithm only) performance was evaluated for the Dream Sock.
- Breathe-down Study: This study directly measured the SpO2 and Pulse Rate accuracy of the device (algorithm) against reference methods under simulated motion and non-motion conditions.
- At-Home Study: This study evaluated the SpO2 and Pulse Rate accuracy of the device in a home environment.
- NICU Study: This study evaluated the alarm functionality (specificity) of the device's algorithms against reference monitoring.
These studies assess the device's inherent ability to measure and alarm without direct human input beyond setting up the device and receiving notifications.
7. Type of Ground Truth Used
The ground truth used in the studies includes:
- Reference Medical Devices: Invasive pulse oximetry, Masimo pulse oximeter, hospital-grade pulse oximeters, and electrocardiogram (ECG) for SpO2 and Pulse Rate measurements and alarm validation.
- Direct Observation/Subjective Assessment:
- Skin irritation assessed through inspections (Skin Observation Study).
- Caregiver responses to notifications in usability testing.
8. Sample Size for the Training Set
The document explicitly states that the subjects in the At-Home Study (35 subjects) were "independent from the algorithm training set." However, it does not provide the sample size for the training set itself.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set was established. It only mentions that the At-Home study's subjects were independent from the training set, implying a separate training phase occurred, but offers no specifics on its data sources or annotation methods.
Ask a specific question about this device
(291 days)
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
| Acceptance Criteria | Reported Device Performance (BabySat 3) | Comments |
|---|---|---|
| SpO2 Accuracy | Non-motion and motion: 70-100% ±3.0% Arms | This includes performance under motion, which the predicate device did not specify. |
| Pulse Rate Accuracy | Non-motion: ±3 bpm Arms; Motion: ±5 bpm Arms | This includes performance under motion. |
| Cleaning/Durability | Components met intended service-life and pre-defined acceptance criteria after testing | Performed on reusable sock and sensor. |
| Electrical Safety, EMC, RFID, Wireless Co-existence | Met performance requirements for intended use and environment, tested against AAMI ANSI ES 60601-1:2005 + A1: 2012, IEC 60601-1-2: 2014, IEC 60601-1-11: 2015 +AMD1: 2020, IEC 60601-1-8 2020, AIM Standard 7351731, and Wireless coexistence standards. | |
| Software | Met all requirements after verification and validation testing | |
| Biocompatibility | Materials met applicable requirements for biocompatibility safety for surface contact, intact skin, permanent use (>30 days). Tested per ISO 10993-5, ISO 10993-10, ISO 10993-11. | Additional ISO 10993-1 testing was performed per Agency feedback. |
| Desaturation Study (SpO2 Accuracy) | Met requirements and was similar to the predicate. Included subjects across the full Fitzpatrick Scale score. | Performed in accordance with FDA guidance and ISO 80601-2-61. |
| Signal Quality (Non-Clinical) | Studied on bench and from clinical data. Results were reportable, but no pass/fail criteria specified. | Additional testing beyond what the predicate performed. |
| Skin Irritation (Observational Study) | No clinically significant skin irritation events were reported when instructions for use were followed. | Collected signal quality data across various use conditions and Fitzpatrick skin tones. |
| Human Factors/Usability | Successful implementation of all critical tasks by intended users (lay people). | Human Factors study was performed with lay users, which was not done for the predicate device. |
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.
Ask a specific question about this device
Page 1 of 1