What happened
Zephyr Sleep Technologies of Calgary, Canada, makes MATRx plus, a sleep test done at home with a motorized mouthpiece that moves the lower jaw forward during the night. After up to six nights, a trained binary classifier predicts whether a patient will respond to an oral appliance, and the test recommends a jaw position. In the study that FDA reviewed, adults with mild to moderate obstructive sleep apnea used the device at home, unattended. Their custom appliances were then set at the recommended position and tested with another sleep test at home. Success meant fewer than 10 drops in blood oxygen of 4% or more per hour. FDA reviewers report a sensitivity of 94.2%, a positive predictive value of 96.1% and a success rate of 86.7% for identifying responders. They report that 86.3% of participants were correctly predicted as responders and given an effective jaw position. Specificity (75.0%) and negative predictive value (66.7%) were low. FDA granted the De Novo request on 23 August 2018. Participants reported temporary jaw and tooth discomfort and disturbed sleep.
Sources
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Regulatory document, by authors with no tie to the system.
U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo Classification Request for MATRx plus (DEN170090): decision summary. Granted 2018-08-23.
Though the specificity and Negative Predictive Value (NPV)were low, the predictive success rate was high (87%). The validity of the test in this population was confirmed by the PPV
Details
AI system
- Workflow
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A dentist measured the range of jaw motion before the first night. Each night's data set the range of jaw positions for the next night, for up to six nights. The classifier labeled each participant a predicted responder or non-responder after the last night.
Follow-up
- Conditions for replication
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The patient has mild to moderate obstructive sleep apnea and enough healthy teeth to hold the trays. Patients fitted with an appliance have further sleep testing to confirm that it works.
Entry details
- Sector
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Healthcare.
- Purpose
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Zephyr Sleep Technologies built MATRx plus to predict which patients with mild to moderate sleep apnea will respond to an oral appliance and to recommend a jaw position.
Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.
Cite this record
Peter H. Vartanian. (2026). MATRx plus picked apnea patients who did well with a mouthpiece (AIBD-0785). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0785.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)