(633 days)
The Embla BreathSensor provides a qualitative air flow signal by oral and/or nasal temperature sensitive resistive components for recording onto a recording system in support of airflow analysis and sleep studies.
The Embla BreathSensor does not provide any diagnostic conclusion about the patient's condition to the user.
The Embla BreathSensor user is a qualified medical practitioner in a hospital environment only who will exercise their professional judgment in using this information.
The Embla BreathSensors (Model 970 Series) are airflow thermistors used as an accessory to a polysomnogram (PSG) or sleep study recording system. The BreathSensor family is comprised of two different variations: Models 971 Adult and Model 974 Small Adult/Child.
The BreathSensors are for use with any standard PSG amplifier or recorder. An interface cable connects the BreathSensor to the polysomnography equipment.
Embla BreathSensors are designed to provide a qualitative measure of respirations (flow) from the mouth and/or nose. The user selects the appropriate size of BreathSensor based on their clinical judgment.
The nasal and/or oral temperature sensor elements are carbon ink placed on a substrate. The carbon ink is the temperature sensitive material. Silver ink interfaces with the carbon ink temperature sensing elements to provide a connection to the interface cable.
The Embla BreathSensors are non-sterile, single patient use, disposable devices.
The Embla BreathSensors are a medical device used to provide a qualitative airflow signal for sleep studies. The device utilizes oral and/or nasal temperature-sensitive resistive components to record airflow onto a recording system.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria with ranges or thresholds for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various evaluations. The acceptance criterion for each evaluation is simply "Pass", indicating that the device met the specified requirements for that test.
| Feature | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate, meeting specific requirements) | Reported Device Performance |
|---|---|---|
| Dimensions | Verification of dimensions. | Pass |
| Labels and Labeling | Verification of label and labeling content for variations. | Pass |
| Material | Verification of specified materials. | Pass |
| Biocompatibility of patient contact materials | Supported with final finished form cytotoxicity, sensitization, and irritation evaluations. | Pass |
| Resistance | Verify BreathSensor base resistance. | Pass |
| Temperature Sensitivity | Verify minimum temperature sensitivity of resistance change per ℃. | Pass |
| Performance Testing | Comparison with predicate Disposable Flow Sensor, evaluation of qualitative airflow response with Interface Cable. | Pass |
| Electromagnetic compatibility | Compliance with IEC 60601-1-2:2014, 4th edition (for BreathSensor and Interface Cable). | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any of the performance tests.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. The studies are described as "evaluations conducted to confirm compliance with performance requirements," suggesting they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. Given the nature of the device (a qualitative airflow sensor), the "ground truth" for its performance tests likely refers to objective measurements against established standards or comparisons with the predicate device, rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method. As noted above, the evaluation seems to rely on objective measurements and comparisons rather than subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done or reported. The device is a qualitative airflow sensor that provides a signal, not a diagnostic algorithm that human readers would use to make decisions. Therefore, a study to measure human reader improvement with or without AI assistance is not applicable here.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the studies described are for standalone device performance. The performance tests (dimensions, material, resistance, temperature sensitivity, biocompatibility, EMC) evaluate the physical and electrical characteristics of the Embla BreathSensors and its interface cable, independent of a human user's interpretation of the signal provided by the device. The "Performance Testing" which involves "Comparison with predicate Disposable Flow Sensor, evaluation of qualitative airflow response with Interface Cable" also appears to be a standalone assessment of the device's ability to generate the expected signal.
7. Type of Ground Truth Used:
The ground truth used for these evaluations appears to be a combination of:
- Objective measurements against engineering specifications: For features like dimensions, resistance, and temperature sensitivity.
- Compliance with recognized standards: For biocompatibility (cytotoxicity, irritation, sensitization evaluations) and electromagnetic compatibility (IEC 60601-1-2:2014).
- Comparison to predicate device performance: For qualitative airflow response during performance testing.
8. Sample Size for the Training Set:
Not applicable. This device is a hardware sensor, not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As stated above, this device does not involve a training set.
§ 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).