(141 days)
The Serenity Piezo and Serenity Thermocouple Sensors are intended to measure and limb movement and thermal respiratory flow signals, respectively, from a patient for archival in a polysomnography study.
The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders.
The Serenity Piezo and Serenity Thermocouple Sensors are intended for use on both adults and children by healtheare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional.
The Serenity Piezo and Serenity Thermocouple Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of:
- an alarm or alarm system;
- · an apnea monitor or apnea monitoring system; or
- · life monitor or life monitoring system.
Serenity sleep sensors are intended to measure and output physiologic signals used for Polysomnography (PSG) or Sleep Studies. These devices are to be used as an accessory to compatible amplifiers.
Typical sleep amplifiers use sensors and electrodes to collect physiological signals to further digitize, and the amplifiers send these signals to a host PC.
Serenity sleep sensors are worn by the patient and connected directly to compatible inputs of an amplifier. The amplifier and related software then processes the signal for review by qualified practitioners to score polysomnograms and diagnose Sleep Disorders.
The Serenity Piezo Sensor uses an embedded piezo sensing element to detect the vibrations of snoring or to sense a patient's limb movement. The sensor outputs a signal which corresponds to movements of the limbs or snore vibrations. The Piezo sensor can be placed on the skin or worn in a heel strap.
The Serenity Thermocouple Sensor uses thermocouple wire that is ioined together to form sensing elements. Thermocouple junctions under each nostril and in front of the mouth output a signal which corresponds to the patient's thermal airflow. The Serenity Thermocouple sensor is available with an optional cannula hanger to aid in patient usability when worn with an airflow pressure cannula.
The Neurotronics Serenity Piezo Sensor and Serenity Thermocouple Sensors are medical devices intended to measure and output physiological signals (snore, limb movement, and thermal respiratory flow) for polysomnography studies. The provided text describes several non-clinical tests conducted to demonstrate the device's performance and safety.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Specified in 60601-1, Dielectric Strength (1.5 kVAC, 10s ramp, 1 min), Ingress of Liquids, Patient Leads (21CFR898) | All samples passed the acceptance criteria. |
| Piezo Sensor Verification | Signal Level: Movement and vibration clearly visible with recommended configuration. Output signal within listed specifications. | All samples passed the acceptance criteria. |
| Wire Test: Connector Retention >= 4.5N, Tensile Strength >= 50N, Leadwire Resistance = 3,650 | All samples passed the acceptance criteria. | |
| Thermocouple Sensor Verification | Signal Level: Oral and Nasal breathing clearly visible at sensitivity of 20. Output signal within listed specifications. | All samples passed the acceptance criteria. |
| Wire Test: Connector Retention >= 4.5N, Tensile Strength >= 50N, Leadwire Resistance = 3,650 | All samples passed the acceptance criteria. | |
| Reference Device Comparison (Piezo) | Sensor snore response to vibration relative to noise floor (SNR) at varied frequencies and complex waveforms using recommended polysomnography montage configuration. Sensor limb movement response to movement. Output signal within listed specifications. | Comparison testing shows equivalent performance of the Serenity sensors and the reference devices. |
| Reference Device Comparison (Thermocouple) | Sensor response as warm air passes (signal cessation attenuated by >=90% of pre-event baseline). Output signal within listed specifications. | Comparison testing shows equivalent performance of the Serenity sensors and the reference devices. |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5 (in vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization). | All samples passed the acceptance criteria for the performed biocompatibility testing. |
| Sterility | Not applicable (device is not sterile). | Not applicable (device is not sterile). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific numerical sample size used for each individual test (e.g., "50 devices were tested"). Instead, it states "All samples passed the acceptance criteria" for electrical safety, piezo sensor verification, and thermocouple sensor verification. The reference device comparison also mentions "comparison testing shows equivalent performance."
- Sample Size: Not explicitly quantified. "All samples" is used consistently, implying a sufficient number were tested to be representative and satisfy the acceptance criteria.
- Data Provenance: The studies are non-clinical testing conducted by the manufacturer, Neurotronics, Inc. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human patient data. These are engineering and performance validation tests, not clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable as the tests described are non-clinical engineering and performance validations, not studies involving human interpretation or diagnosis. Therefore, there is no "ground truth" established by human experts in the context of the device's diagnostic performance. The ground truth for these tests is defined by the technical specifications and standards (e.g., signal level, resistance, tensile strength, ISO standards).
4. Adjudication Method for the Test Set
This section is not applicable as the tests are non-clinical and do not involve human interpretation or subjective assessment that would require adjudication. The results are objective measurements against defined technical criteria.
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
This section is not applicable. The device (Serenity Piezo Sensor, Serenity Thermocouple Sensor) is a sensor that collects physiological signals, not an AI-powered diagnostic tool for interpretation by a human reader. Its function is to accurately measure and output signals, not to process them with AI or aid in human interpretation improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a sensor; it does not contain a standalone algorithm for diagnostic performance. It outputs raw physiological signals for analysis by a polysomnography system and qualified sleep clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" is based on:
- Technical Specifications: Defined parameters for signal level, electrical properties (dielectric strength, resistance), mechanical properties (connector retention, tensile strength, mating cycles).
- International Standards: ISO 10993 for biocompatibility and IEC 60601-1 for electrical safety.
- Reference Device Performance: The performance of the Serenity sensors was compared to established performance characteristics of predicate and reference devices, implying these established devices serve as a benchmark for "ground truth" equivalence in signal output.
8. The sample size for the training set
This section is not applicable. The device is a sensor, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML development.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).