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510(k) Data Aggregation
(152 days)
Withings Scan Monitor 2.0
The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a twochannel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVF, aVL. The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician).
The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.
The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.
The Withings Scan Monitor 2.0 is a connected smart scale with a retractable handle, with Bluetooth and Wi-Fi capabilities that connects to a companion mobile application. The Withings Scan Monitor 2.0 is intended to create, record, store, transfer and display lead-III of a two-channel electrocardiogram (ECG).
When a user stands on the scale and holds the handle attached to it, a 30 second ECG recording begins. The Withings Scan Monitor 2.0 software analyzes data collected by the electrical sensors present on the scale to generate lead-III simultaneously and derive lead-I and leads aVR, aVF and aVL, calculate heart rate, and provide a rhythm classification to the user that is displayed on the scale. The companion application is intended to display, store, manage and share data.
The Withings Scan Monitor 2.0 classifies ECG signals as follows:
- Normal Sinus Rhythm
- Atrial Fibrillation
- Inconclusive
- Noise - Inconclusive
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document defines acceptance criteria primarily through the clinical study results and comparison to the predicate device.
| Acceptance Criteria | Reported Device Performance (Withings Scan Monitor 2.0) |
|---|---|
| AF detection sensitivity (all outputs) | 0.73 [95% CI lower bound: 0.639] |
| AF detection specificity (all outputs) | 0.955 [95% CI lower bound: 0.914] |
| AF detection sensitivity (AF/NSR only) | 0.989 [95% CI lower bound: 0.928] |
| AF detection specificity (AF/NSR only) | 0.994 [95% CI lower bound: 0.968] |
| Visibility accuracy of P-waves, QRS complexes, T-waves | Above 0.992 |
| Polarity accuracy of P-waves | 0.986 |
| Polarity accuracy of QRS complex | 0.948 |
| Polarity accuracy of T-waves | 0.911 |
| Standard deviation of difference in PR interval duration (vs 12-lead ECG) |
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(491 days)
Scan Monitor
The Scan Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Scan Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under the care of a physician). The Scan Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.
The Scan Monitor is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2). The Scan Monitor is intended for spot-checking of adult patients in hospitals, clinics, long-term care facilities, and homes.
The Scan Monitor is a wearable, Bluetooth-connected wrist-worn watch that records two medical measurements-heart activity (electrocardiogram (ECG)) and oxygen saturation (SpO2)-as well as other measurements including step cycles, running, biking, and walking. The Scan Monitor has a companion mobile application called Health Mate. The Scan Monitor is available in two sizes, 38 mm and 42 mm, which have different watch faces but are otherwise identical.
The Scan Monitor has two stainless steel electrodes integrated on the back case of the watch and are always in contact with the skin. One of these two electrodes is used to obtain a reference signal and reduce the noise on the ECG signal. A third electrode is accessible by the free hand (the hand that does not wear the device) on the top of the device.
The Scan Monitor classifies ECG signals as follows:
- 0 Normal Sinus Rhythm;
- Atrial Fibrillation; .
- . Inconclusive;
- 0 Noisy.
The SpO2 measurements are obtained by a photoplethysmograph sensor located at the backcase of the product. This sensor is composed of three LEDs (green, red, and infrared) and two photodiodes (one large band and one with a green filter). The Scan Monitor is validated for an SpO2 range of 70% to 100% and an SpO2 range between 85% to 100% is displayed on the gauge.
All measurements obtained by the Scan Monitor are available in the companion Health Mate app.
The Withings Scan Monitor has two main functionalities: ECG rhythm recording and Atrial Fibrillation (AFib) detection, and SpO2 measurement. Here's a breakdown of the acceptance criteria and study information for each:
ECG Rhythm Recording and Atrial Fibrillation (AFib) Detection
1. Table of Acceptance Criteria and Reported Device Performance (AFib Detection)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity (of AFib detection) | 96.3% (95% CI lower bound: 89.4%) |
| Specificity (of AFib detection) | 100% (95% CI lower bound: 96.7%) |
2. Sample Size and Data Provenance
- Test Set Sample Size: 262 participants
- Data Provenance: Prospective, multicentric, comparative, cross-over study. The document does not specify the country of origin of the data.
3. Number and Qualifications of Experts for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience) used to establish the ground truth for the ECG study. It implicitly refers to "clinical performance" evaluation, suggesting medical professionals were involved in defining the ground truth for AFib and normal sinus rhythm.
4. Adjudication Method
The document does not specify the adjudication method (e.g., 2+1, 3+1, none) for the test set's ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly mentioned. The study focused on the performance of the Scan Monitor software itself.
6. Standalone Performance
Yes, a standalone performance study was done for the AFib detection algorithm. The reported sensitivity and specificity are for the device's software detecting AFib.
7. Type of Ground Truth Used
The ground truth for the AFib detection study was established through clinical evaluation, likely by expert interpretation of reference ECGs, given its "clinical performance" context.
8. Sample Size for Training Set
The sample size for the training set is not provided in the document.
9. How Ground Truth for Training Set was Established
The document does not provide details on how the ground truth for the training set was established.
SpO2 Measurement
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Met acceptance criteria set forth in FDA's guidelines and ISO 80601-2-61. | The clinical study results demonstrated that the device met the acceptance criteria and showed comparable performance to the chosen reference device (Oxitone 1000). Specific quantitative metrics (e.g., accuracy, bias) are not provided in this summary but are referenced as meeting the standards. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 15 participants
- Data Provenance: Clinical study. The document does not specify the country of origin or whether it was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications used to establish the ground truth for the SpO2 study. Ground truth for pulse oximetry is typically established using a reference oximeter or arterial blood gas analysis in a controlled setting.
4. Adjudication Method
The document does not specify the adjudication method for the SpO2 test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not mentioned for the SpO2 functionality.
6. Standalone Performance
Yes, a standalone performance study was done for the SpO2 functionality, as the device's measurement performance was evaluated against established standards and a reference device.
7. Type of Ground Truth Used
The ground truth for the SpO2 study was established in accordance with IEC 80601-2-61:2017 and FDA's guidance for pulse oximeters, which typically involves comparing the device's readings to a validated reference method, such as arterial blood gas analysis or a highly accurate laboratory oximeter.
8. Sample Size for Training Set
The sample size for the training set is not provided in the document.
9. How Ground Truth for Training Set was Established
The document does not provide details on how the ground truth for the training set was established.
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