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510(k) Data Aggregation
(29 days)
Huxley Medical
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, 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 the clinical and home use setting under the direction of a Healthcare Professional (HCP).
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 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 (reference channel only). 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. The ECG channel is used for diagnostic purposes and is not intended by any automated ECG analysis system or algorithm.
This document (K244027) is a Special 510(k) submission for the SANSA HSAT device, focusing on adding cellular capability. This type of submission is used when a modification to an already cleared device does not significantly change its safety or effectiveness or its indications for use. Therefore, the information provided primarily concerns the equivalence of the modified device to its predicate (which is its own previous version, K240285).
The document states that there are no changes to the Indications for Use, physical hardware, principles of operation, device offerings, manufacturing process, or device packaging as part of the cellular update. This means that the core performance characteristics related to sleep apnea detection and physiological measurements have already been established and cleared with the predicate device.
Given this context, the document does not contain a new, comprehensive clinical study proving the device meets new acceptance criteria for its core function (sleep apnea detection). Instead, it focuses on non-clinical testing to demonstrate that the addition of cellular capability does not negatively impact the device's original performance and introduces no new safety or effectiveness concerns.
Therefore, many of the requested points regarding acceptance criteria and clinical study details for the sleep apnea detection function are not included in this specific Special 510(k) document, as they were addressed in the original clearance (K240285). The performance claims for the device (e.g., Sensitivity, Specificity for OSA) are listed as "Identical" to the predicate, meaning these were established in the predicate's clearance.
However, I can extract the information related to the changes made and the testing performed for this specific submission (K244027):
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For the specific change (cellular capability), the document does not present a table of new clinical acceptance criteria. Instead, it asserts that the performance remains "Identical" to the predicate, and non-clinical testing verifies that the cellular addition does not degrade this performance.
The "Performance" criteria listed under the "Device Comparison" table are for the main function of the device (sleep apnea detection and physiological measurements), which are stated to be identical to the predicate. These are not new acceptance criteria for the cellular update, but rather the previously established performance of the base device.
| Performance Metric (from Predicate) | Acceptance Criteria (from Predicate) | Reported Device Performance (for Subject Device) |
|---|---|---|
| Heart Rate | Rms ≤ 3 bpm (range 30-250 bpm) | Rms ≤ 3 bpm (range 30-250 bpm) (Identical) |
| SpO2 | Rms ≤ 3% (range 70-100%) | Rms ≤ 3% (range 70-100%) (Identical) |
| Aid to Diagnosis of Moderate to Severe OSA (AHI ≥ 15) Sensitivity | 88.2% | 88.2% (Identical) |
| Aid to Diagnosis of Moderate to Severe OSA (AHI ≥ 15) Specificity | 87.3% | 87.3% (Identical) |
For the cellular capability itself, the acceptance is implicitly based on:
- Successful wireless data transfer via Cellular (LTE-M).
- No regression in existing functionality.
- Maintenance of data integrity during upload.
- Meeting cybersecurity requirements.
- Compliance with wireless testing standards (FCC 47 CFR Part 15, Part 24, Part 27, Part 2).
2. Sample Size Used for the Test Set and Data Provenance
This Special 510(k) primarily relies on non-clinical testing for the cellular capability. Therefore, there is no "test set" in the sense of a patient cohort for a clinical study.
- Test Set (for the cellular update): Not applicable in terms of patient data. The testing involved software testing, cybersecurity testing, and wireless testing. The sample size for these types of tests would be in terms of test cases, configurations, and test environments, not patient data.
- Data Provenance: Not applicable for the cellular update. The statement "Identical" for performance refers to the original data from the predicate device's clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable for this Special 510(k) submission, as no new clinical study requiring ground truth establishment by experts for sleep apnea diagnosis was performed for the cellular update. The "Identical" performance refers to the ground truth established for the predicate device.
4. Adjudication Method for the Test Set
Not applicable for this Special 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This submission is for a modification (cellular capability) to an existing device, not a new AI-assisted diagnostic tool requiring a human-in-the-loop MRMC study. The "device performance" listed is for the standalone device, not in assistance with human readers in a comparative setting.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the performance metrics (Sensitivity, Specificity for OSA, Heart Rate, SpO2 accuracy) listed in the "Device Comparison" table represent the standalone performance of the SANSA HSAT device's algorithms, without human intervention in the interpretation of these core metrics. These metrics are stated to be "Identical" to the predicate, implying this standalone performance was established during the predicate's clearance.
7. The Type of Ground Truth Used
For the core function of sleep apnea evaluation (sAHI, etc.), the document does not explicitly state the ground truth used. However, for sleep apnea diagnostics, the common ground truth is Polysomnography (PSG) scored by board-certified sleep technologists and interpreted by board-certified sleep physicians. Since the device aids in the evaluation of sleep-related breathing disorders, it's highly likely that full PSG served as the ground truth for the predicate device's performance validation. This document does not provide details of the ground truth for the predicate.
8. The Sample Size for the Training Set
The document does not provide information on the training set sample size. This would have been part of the original K240285 submission, as this document focuses only on changes related to cellular connectivity.
9. How the Ground Truth for the Training Set was Established
The document does not provide information on how the ground truth for the training set was established. This would have been part of the original K240285 submission.
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(165 days)
Huxley Medical
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, 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 the clinical and home use setting under the direction of a Healthcare Professional (HCP).
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 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 Al/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 (reference channel only). 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. The ECG channel is intended to be used as a reference channel and is not intended to be used for diagnostic purposes and is not intended by any automated ECG analysis system or algorithm.
Here's a breakdown of the acceptance criteria and study details for the Huxley SANSA Home Sleep Apnea Test (SANSA HSAT), based solely on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (SANSA HSAT) |
|---|---|---|
| Heart Rate Accuracy | 30-300 bpm ± the greater of ±10% or ±5 bpm | Arms ≤ 3 bpm (range 30-250 bpm) |
| SpO2 Accuracy (70-100%) | Arms ≤ 3% | Arms ≤ 3% |
| Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Sensitivity | 90% | 88.2% (95% Cl: 81.3, 93.2) |
| Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Specificity | 98% | 87.3% (95% Cl: 82.1, 91.5) |
| SpO2 Average Root Mean Square Error (Agrms) | ≤ 3.5% (for reflectance technology) | 2.4% (Overall) |
| Sleep/Wake Classification: Sensitivity (Sleep) | (Not explicitly stated in reported predicate performance) | 95% (95% Cl: 95, 95) |
| Sleep/Wake Classification: Specificity (Sleep) | (Not explicitly stated in reported predicate performance) | 63% (95% CI: 62, 64) |
Note: The table combines the "Performance" section for the predicate and subject devices from the Device Comparison table (page 7) and the "Clinical Performance Data" section for additional reported performance values (page 12). For Sleep/Wake classification, no direct "acceptance criteria" based on the predicate were provided in the document.
2. Sample size used for the test set and the data provenance:
- SpO2 Accuracy Test Set: The number of subjects is not explicitly stated, but the test was conducted on "healthy subjects" (page 12).
- Comparison to PSG (Moderate to Severe SDB Diagnosis Test Set):
- Sample Size: n = 533
- Data Provenance: Prospective multi-center clinical study in the United States (page 12).
- Sleep/Wake Classification Validation Test Set:
- Sample Size: n = 340 (ITD - likely "Intention To Diagnose")
- Data Provenance: Not explicitly stated beyond being "gold standard scored PSG data" (page 12).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not explicitly provided in the text. The ground truth for the comparison to PSG study is stated as "gold standard polysomnography (PSG)" (page 12), and for SpO2, it's "arterial blood gas samples" (page 12). While PSG scoring generally involves experts (e.g., sleep specialists, polysomnographic technologists), the number and specific qualifications of these experts are not detailed in this document.
4. Adjudication method for the test set:
This information is not explicitly provided in the text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not explicitly described. The study focused on the standalone diagnostic performance of the SANSA device compared to PSG. The predicate device's diagnostic performance is noted as being based on "manual scoring of data by HCP" (Healthcare Professional), while the subject device "utilizes an autoscored algorithm with no overread and correction." This suggests a comparison of the AI-driven auto-scoring performance to a human-scored gold standard, but not a study of human readers improving with AI assistance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The "Comparison to PSG" study (n=533) directly evaluates the diagnostic performance of the SANSA device's algorithm for moderate to severe SDB, stating it "utilizes an autoscored algorithm with no overread and correction" (page 7) and yielded specific sensitivity and specificity values. The Sleep/Wake classification also reports algorithm-only performance.
7. The type of ground truth used:
- For SpO2 Accuracy: Arterial blood gas samples (page 12).
- For comparison to PSG (SDB diagnosis) and Sleep/Wake classification: Gold standard polysomnography (PSG) data (page 12).
8. The sample size for the training set:
- For the Sansa device AI-based Sleep/Wake classification algorithm: 101 subjects (page 12).
- For other algorithms (e.g., AHI calculation): This information is not explicitly provided.
9. How the ground truth for the training set was established:
- For the Sansa device AI-based Sleep/Wake classification algorithm: The algorithm was "trained on 101 subjects and validated against the validation dataset (n=340 ITD) taken from gold standard scored PSG data" (page 12). This implies the ground truth for the training set was also established using "gold standard scored PSG data."
- For other algorithms: This information is not explicitly provided.
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