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The MATRx plus is indicated for use by a lay person in a home and hospital use under the direction of a Health Care Professional (HCP).

MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.

MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.

The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.

MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for oral appliance therapy and to recommend a target mandibular position.

The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.

MATRx plus is a ventilatory effort recorder and closed loop auto-titration device for oral appliances. MATRx plus is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, snoring, respiratory effort, pulse rate, oxygen saturation, and body position during sleep.

The device is worn on the patient's abdomen attached to a reusable effort belt and all relevant respiratory information during sleep is collected via nasal cannula, pulse oximetry module, and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and fixed at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives input from the sensors and wirelessly transmits the data to a bedside Tablet during the study. The Tablet is set up through a connection to the web portal by the healthcare professional (HCP) prior to deploying the device to the patient for home use. The Tablet runs the MATRx plus application and records and stores the data. The MATRx plus application on the Tablet is also used to guide the user through the set up and conduct of the study through a stepwise user interface. At the end of a recording, the Tablet advises the patient if sufficient data for analysis were recorded during the night.

During an auto-titration study, the patient wears temporary Titration Trays connected to a mandibular positioner. During the study, the device moves the mandible in response to respiratory events in order to determine if the patient is a suitable candidate for oral appliance therapy.

After recording, the MATRx plus must be returned to the HCP. The data are automatically uploaded to the secure Portal where they can be accessed and downloaded to the Data Viewer. The Data Viewer can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis (when used as a ventilatory effort recorder) or to assist the HCP in the clinical management of oral appliance therapy for patients with obstructive sleep apnea.

The device is intended to be used on adult patients, upon referral from their healthcare provider.

The device is not to be used as an apnea monitor or in a life supporting or life sustaining situation and must not be used in the vicinity of an MRI device.

The MATRx plus device underwent non-clinical and clinical testing to demonstrate its substantial equivalence to its predicate device (K191925).

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set:

The provided document does not explicitly state the exact sample size for the test sets in either the single-arm or cross-over study. It mentions the "mild/moderate patient population" for the single-arm study.
The provenance of the data is not specified in terms of country of origin. The studies are described as prospective.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document.

4. Adjudication Method for Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. Instead, it describes a "cross over study" to directly compare the subject device's performance to the predicate device, focusing on predictive accuracy and target protrusive position.

6. Standalone Performance:

Yes, a standalone performance study was done. The "single arm study" and "cross over study" evaluate the device's ability to predict outcomes and recommend mandibular positions, which are standalone functions of the algorithm. The device, an "Auto Titration Device For Oral Appliances," appears to operate without direct human intervention in its primary functions during the study.

7. Type of Ground Truth Used:

For the single-arm study, the ground truth was "previously established clinical endpoints used to clear the original MATRx plus device" for determining "responder/non-responder" status in the mild/moderate patient population. For the cross-over study, the ground truth for comparison was the performance of the predicate MATRx plus device (K191925) in terms of predictive accuracy and target protrusive position.

8. Sample Size for Training Set:

This information is not provided in the document. The document describes testing the subject device, suggesting the training would have occurred prior to these validation studies.

9. How Ground Truth for Training Set Was Established:

This information is not provided in the document.

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