(266 days)
The Maxxi Snore Sensor is a device intended to acquire snore bursts. It responds to snoring and other sounds in the audio range picked up through the skin and convert them to a small analog voltage that provides an indication of the presence of these sound/vibration bursts. 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 SNORE SENSOR piezo electric based sensors detect sound and vibration of the snore through skin contact. The sensor is placed on the patient neck surface where it can easily detect the snoring bursts during the sleep study. The product is offered in 2 different length sizes, 3ft and 7ft. The sensor is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for PSG recording machines.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Maxxi Snore Sensor:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Parts Dimensions | Allowance: +/-10% | "The dimensions of the piezo electric unit are within the acceptable criteria as when compared to the predicate device." |
| Cable Length | 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 | All aspects must be substantially equivalent to the predicate device. | "Maxxi Snore sensor was inspected, and the result is equivalent to the predicate device." |
| Output Signals Frequency and Amplitude Tests | Allowance: +/-15% | "Both sensors acquired equivalent signals within the acceptable range." (meaning within +/-15% of each other, assuming the predicate device's output is the reference) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the performance testing.
The data provenance is also not explicitly stated beyond comparing the Maxxi Snore Sensor to a predicate device. It is indicated as performance testing rather than a study on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance testing appears to be a direct comparison of physical properties and signal output against a predicate device, rather than a clinical study requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (dimensions, cable length, visual inspection, signal comparison against a predicate), a formal adjudication method by experts is not described or implied.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
A MRMC comparative effectiveness study was not done. The device is described as a sensor that outputs analog voltage for polysomnography devices, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
A standalone performance study of an algorithm was not done. The device is hardware. The performance described is related to its physical characteristics and direct signal output, not algorithmic interpretation.
7. The Type of Ground Truth Used
The "ground truth" used for performance testing was the specifications and output of a legally marketed predicate device (S.L.P. Ltd.'s Snoring Sensor K941759). The Maxxi Snore Sensor's performance was evaluated against the predicate device to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable as the Maxxi Snore Sensor is a hardware device (piezoelectric sensor) that detects sounds/vibrations and converts them to an analog voltage. It does not involve machine learning or AI that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for this type of device.
§ 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).