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510(k) Data Aggregation
(219 days)
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing and cardiac disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only.
The SANSA device records and stores ECG recording for up to 10 hours of wear time which can be displayed in the software portal for manual annotation and analysis. The SANSA does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm and is not intended for pacemaker analysis.
The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only. The SANSA™ device records and stores ECG recording for up to 10 hours of wear time which can be displayed in the software portal for manual annotation and analysis. The SANSA™ does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm and is not intended for pacemaker analysis.
The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output. The device outputs the following time-series channels: Oximetry, Heart Rate, Chest Movement, Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging (Sleep/Wake), and ECG. The following summary metrics are calculated: sansa-Apnea Hypopnea Index (sAHI) and Total Sleep Time (TST).
Recorded data are uploaded to a software portal where physiological tracings are made available for review and event editing by a qualified healthcare professional. The device is intended to be worn for 10 hours per study.
Here's a breakdown of the acceptance criteria and the study information for the SANSA HSAT device, based on the provided FDA 510(k) clearance letter:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are primarily found on Page 9 of the document, under the "Performance" section within "Table 1: Device Comparison."
| Performance Metric | Acceptance Criteria / Predicate Performance (K202359) | Reported Device Performance (SANSA HSAT) | Comparison |
|---|---|---|---|
| Heart Rate (Arms) | No Heart Rate Analysis (Predicate) | ≤ 3 bpm (range 30-250 bpm) | N/A |
| SpO2 (Arms) | Does not collect SpO2 (Predicate) | ≤ 3% (range 70-100%) | N/A |
| Aid to Diagnosis of Moderate to Severe OSA (AHI≥15) - Sensitivity | Not applicable (Predicate does not diagnose OSA) | 88.2% | N/A |
| Aid to Diagnosis of Moderate to Severe OSA (AHI≥15) - Specificity | Not applicable (Predicate does not diagnose OSA) | 87.3% | N/A |
| ECG Recording Accuracy: Frequency Response | 0.67 Hz to 40 Hz | 0.67 Hz to 40 Hz | Identical |
| ECG Recording Accuracy: Input Impedance | >10 MΩ | >10 MΩ | Identical |
| ECG Recording Accuracy: Gain Accuracy | Maximum amplitude error ±10% | Maximum amplitude error ±10% | Identical |
| ECG Recording Accuracy: Gain Stability | <3% over a 24-hour period | <3% over a 24-hour period | Identical |
| ECG Recording Accuracy: Timing Accuracy | <30 seconds | <30 seconds | Identical |
Note: For Heart Rate, SpO2, and OSA diagnosis metrics, the predicate device (iRhythm Zio Monitor) does not provide these analyses or collect SpO2. Therefore, the "acceptance criteria" for these aspects are implicitly met by the absence of safety/effectiveness concerns with the SANSA HSAT's reported performance, which aligns with its intended use in sleep apnea evaluation. The ECG recording accuracy metrics are directly comparable and are identical between the subject device and the predicate.
2. Sample Size and Data Provenance for the Test Set
The document does not explicitly state the sample size used for the clinical performance validation of the SANSA HSAT's ECG, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions:
- Sample Size: Not specified.
- Data Provenance: Not specified (country/retrospective/prospective).
For the Aid to Diagnosis of OSA, a sensitivity of 88.2% and specificity of 87.3% are reported. The document does not provide the sample size or provenance for this particular study, but it was leveraged from a previous clearance (K244027).
3. Number of Experts and Qualifications for Ground Truth - Test Set
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set specifically for the ECG clinical performance validation.
For the "Aid to Diagnosis of Moderate to Severe OSA", the percentages suggest a comparison against a diagnostic standard, which would typically involve expert interpretation, but the details are not provided in this document.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size related to human reader improvement with or without AI assistance. The SANSA device explicitly states it "does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm." (Pages 4 and 5).
6. Standalone Performance Study
Yes, a standalone performance study was done for the SANSA HSAT's ECG:
- Study Type: "Sansa ECG clinical performance was validated through comparison to a simultaneously collected reference standard Holter monitor." (Page 11)
- Performance: "Clinically acceptable performance was demonstrated through qualitative and quantitative analysis of the ECG signal." (Page 11)
The reported sensitivity and specificity for OSA diagnosis (Page 9) also represent standalone algorithm performance.
7. Type of Ground Truth Used
- For ECG Clinical Performance: "simultaneously collected reference standard Holter monitor." (Page 11)
- For Aid to Diagnosis of OSA (reported sensitivity/specificity): While not explicitly stated, the context of "Aid to Diagnosis" for Sleep Apnea typically implies comparison to a polysomnography (PSG) study, which is the gold standard, interpreted by sleep specialists. This data was "leveraged from previous clearance."
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for a training set. This is consistent with the statement that the device does not provide automated analysis of the ECG and explicitly states that it is not intended for use with a 3rd party automated algorithm. While the device uses "AI/ML components" for other signals (Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging), the training set size for these components is not detailed in this document.
9. How Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established. Given the focus on manual annotation and analysis for ECG, and the lack of detail on the AI/ML components for other signals, this information is not present in the clearance letter.
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