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510(k) Data Aggregation
(192 days)
The Maxxi Flow sensor is a respiratory sensor. It is placed under the patient's and produce a signal that is directly proportional to the temperature changes of air inhaled and exhaled during respiration. Maxxi Flow sensors generate a small analog electrical signal that provides a clear, reliable indication of respiration airflow. This sensor is intended to be used with polysomnography devices and adult patients.
Intended to be use in a sleep laboratory, clinics or hospitals.
MAXXI FLOW SENSOR Thermocouple based sensors detect change of breath temperature between ambient temperature (inhalation) and lung temperature (exhalation). A thermocouple placed in front of a nostril detects breathing as a temperature change.
The product is offered in 2 different length sizes, 3ft and 7ft.
Maxxi Flow sensor is compatible with Neurovirtual PSG devices.
Here's an analysis of the acceptance criteria and study information for the Maxxi Flow Sensor, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance for Maxxi Flow Sensor (K201495)
The Neurovirtual Maxxi Flow Sensor is a respiratory thermocouple flow sensor intended for use with polysomnography devices in adult patients within sleep laboratories, clinics, or hospitals. It is designed to detect temperature changes of inhaled and exhaled air to provide a signal indicating respiration airflow.
Here's the detailed breakdown of its acceptance criteria and the study that proves its compliance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Parts Dimensions | Verify if the dimensions of the thermocouple unit are within the acceptable range and equivalent to the predicate. | Allowance: +/- 10% compared to predicate. | The dimensions of the thermocouple unit are within the acceptable criteria as when compared to the predicate device. |
| Cable Length | Verify if the wire lead length is within the acceptable range and equivalent to the predicate. | Expected: 3 ft and 7 ft. | |
| Allowance: +/- 5%. | The cable length of the sensor is within the acceptable criteria as when compared to the predicate device. | ||
| Visual Conditions | Verify the visual aspects of the product and equivalency with the predicate. Cable aspects, labeling, flexibility, plastic finishing, and connector conditions. | All aspects must be substantially equivalent to the predicate device. | Maxxi Flow sensor was inspected, and the result is equivalent to the predicate device. |
| Sensor Resistance | Verify the resistance of the sensor using the ohmmeter in a controlled test environment where the temperature is stable. | Expected: 0-10 ohms. | The Maxxi Flow was inspected, and the resistance is between the acceptable criteria range (2.0 ohms). |
| Output signals Frequency and Amplitude | The sensor Maxxi Flow and the predicate Easy Flow were connected to the same PSG recorder and the acquired data was compared in frequency and amplitude. | Allowance: +/- 15%. | Both sensors acquired equivalent signals within the acceptable range. |
| Environment Temperature Performance | Test performance with different environment temperatures. (Specific criteria not numerically stated, but the conclusion focuses on equivalence to the predicate.) | Expected to show equivalent performance to the predicate device at different temperatures. | The results showed exact same frequency as the predicate, with minimal difference on voltage amplitude and resistance measurement values. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size of Maxxi Flow Sensors used for the non-clinical testing. However, the tests are described as comparing the Maxxi Flow sensor directly against a single predicate device (Easy Flow manufactured by S.L.P Ltd.). This suggests a comparative test design.
The provenance of this test data is non-clinical testing, performed by the manufacturer, Neurovirtual USA, Inc., implying internal validation. There is no information regarding the country of origin of the data beyond the manufacturer's location in Fort Lauderdale, Florida, USA. The testing appears to be prospective in nature, as it involves newly manufactured devices undergoing specific tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. For this type of non-clinical, performance-based testing of a sensor, "expert ground truth" as typically understood in AI/image analysis studies (e.g., radiologist consensus) is not directly applicable. The "ground truth" for these tests is based on objective measurements against engineering specifications and comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable for these non-clinical, objective performance tests. The criteria are quantitative (e.g., +/- 10% allowance, 0-10 ohms) or qualitative but directly observable (e.g., visual equivalency). Discrepancies would be identified through measurement, not through expert opinion requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI algorithms on human readers' performance, typically in diagnostic imaging. The Maxxi Flow Sensor is a physical medical device (a respiratory sensor), not an AI-powered diagnostic tool, so such a study would not be applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone performance study, as typically understood for AI algorithms, was not conducted because the Maxxi Flow Sensor is a physical device, not an AI algorithm. Its performance is inherent to its physical and electronic design and is measured directly through non-clinical testing. The performance evaluated here is the device's ability to generate signals based on temperature changes.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical testing was based on:
- Engineering Specifications: Pre-defined acceptable ranges for physical dimensions, cable length, and sensor resistance.
- Predicate Device Performance: Direct comparison of output signals (frequency and amplitude) against a legally marketed predicate device (S.L.P. Ltd.'s Thermocouple Flow Sensor (Easy Flow)) under controlled conditions.
- Visual Inspection Criteria: Equivalence to the predicate device in visual aspects.
8. Sample Size for the Training Set:
This information is not applicable as the Maxxi Flow Sensor is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical medical device like the Maxxi Flow Sensor.
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