(296 days)
The SomnaPatch™ is a single use physiologic recorder intended to collect and record data for use by clinical software used in polysomnography and sleep disorder studies by providing the information required for calculation of the apnea-hypopnea index. It is intended for adult use and can be used in a hospital, clinic, or patient home.
The SomnaPatch Home Sleep Test is a single-use disposable physiologic recorder used as an aid in the diagnosis of sleep related breathing disorders. The SomnaPatch device is affixed to the face of the user and is designed to continuously be worn overnight, up to approximately 10-hours. Once activated, the device records and stores patient data for the wear period. After the wear period, the device is returned to the healthcare professional, where the data is downloaded and processed by the SomnaPatch Data Processing Software. The processed data can be viewed by a healthcare professional and analyzed either manually or by third-party sleep data viewing and scoring software. The SomnaPatch device is not involved in the data management performed by the host or third-party data viewing or scoring software.
The forehead patch contains three sensors (Pressure Sensor, Accelerometer, and Optical SpO2), wherein their outputs' are recorded to a secure MicroSD card. The SomnaPatch Data Processing Software installed on a PC downloads the recorded data from the secure MicroSD card to derive 4 channels (nasal pressure, oxygen saturation (SpO2), pulse rate, and head position) of data in EDF format.
Here's an analysis of the provided text to extract information about the SomnaPatch device's acceptance criteria and the study proving it, structured as requested:
Acceptance Criteria and Device Performance for SomnaPatch
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Alice PDx) rather than explicitly stating pre-defined acceptance criteria with precise numerical targets for clinical accuracy. However, based on the clinical study summarized and the comparison section, we can infer the performance considered acceptable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Clinical Study and Comparison) | Reported Device Performance (SomnaPatch) |
|---|---|
| AHI Accuracy (vs. Gold Standard PSG) | Mean difference in AHI: -0.7 events per hour (95% confidence interval -2.4 to 1.1 events/hour). |
| The device "accurately estimates the AHI for values >=15 events/hour as compared with in-lab polysomnography (PSG)." | |
| SpO2 Signal Accuracy | Performs within the standard accuracy range of ±4% for non-invasive pulse oximetry, "the same as compared to Alice PDx." |
| Sensor Performance (Optical SpO2, Accelerometer, Pressure) | Optical SpO2: Comparable performance to Nonin pulse oximeters (mentioned as predicate device's compatible oximeters) and agreed with expected pulse rate. |
| Accelerometer: Performed comparably to the Alice PDx accelerometer, recording all motion as intended. | |
| Pressure Sensor: Detected hypopneas and apneas generated by ASL scripts comparably to Alice PDx pressure-based flow. | |
| Biocompatibility | No potential for cytotoxicity, sensitization, or negligible irritation results. Acute systemic toxicity showed no evidence of mortality or toxicity. (Considered biocompatible per ISO 10993). |
| Safety (General, Electrical, EMC) | Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, IEC 60601-1-11:2015, and ISO 80601-2-61: 2011. All product requirements met with passing test results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study for AHI accuracy): 178 participants
- Data Provenance (Clinical Study for AHI accuracy): Multi-center, open-label study (country of origin not explicitly stated, but submission is to US FDA, implying relevance to US market). The study involved a "within-subject comparison" against overnight polysomnography (PSG) in a laboratory setting. This indicates a prospective study design for data collection against the gold standard.
- Sample Size (Clinical Testing for SpO2 signal): Not explicitly stated, but refers to "arterial blood samples drawn under hypoxic conditions over the SaO2 range of 70-100%."
- Data Provenance (Clinical Testing for SpO2 signal): Partnered with University of California San Francisco (UCSF) Hypoxia Research Laboratory. This is likely a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth for scoring the AHI from the gold standard PSG, beyond referring to "in-lab polysomnography (PSG)" being the gold standard. For the SpO2 testing, the ground truth was "arterial blood samples," which is an objective physiological measure, not dependent on expert interpretation.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method for the test set regarding AHI scoring or any other clinical readouts. It mentions "in-lab polysomnography (PSG)" as the gold standard, implying that the AHI from PSG was considered definitive.
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 involving human readers with and without AI assistance was not conducted or described. The clinical study focused on the device's standalone accuracy in estimating AHI compared to PSG, not on assisting human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The clinical study described for AHI accuracy directly assessed the SomnaPatch device's ability to estimate AHI compared to the gold standard PSG. The SpO2 accuracy validation was also a standalone assessment against arterial blood samples. The device processes data via software to derive channels and calculate AHI, which is then viewed and analyzed by a healthcare professional. The core evaluation is the device's accuracy in producing this data, which is a standalone performance metric.
7. The Type of Ground Truth Used
- For AHI Accuracy: Overnight polysomnography (PSG) in a laboratory setting (clinical gold standard).
- For SpO2 Accuracy: Arterial blood samples (objective physiological measurement).
- For Sensor Performance (Pressure): Hypopneas and apneas generated using ASL scripts, then viewed in Sleepware G3. This appears to be a simulated, controlled environment ground truth rather than real patient data for this specific sensor comparison.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. The device appears to be a physiological recorder that provides raw/processed data channels (like nasal pressure, SpO2) and then relies on clinical software or healthcare professionals to calculate AHI. There's no indication that the device itself uses a trainable algorithm in the sense of deep learning or machine learning that would require a distinct training set for its core function of recording and deriving these physiological channels.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of a trainable algorithm (see point 8), this information is not applicable and therefore not provided in the document. The device's function is data collection and processing based on sensor readings.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).