MATRx plus

DEN170090

Zephyr Sleep Technologies · granted 2018-08-23 · product code QCJ · Dental

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“The device is an automated temporary oral appliance that manipulates the mandible through multiple protrusion levels during an overnight sleep study in the home. The device uses the same interface as the MATRx plus Home Sleep Apnea Test, also from Zephyr Sleep Technologies, cleared under product code MNR, regulation 21 CFR 868.2375, cleared in K163665. These components include the recorder, tablet, oximeter, effector belt, and nasal cannula. The MATRx plus device for a titration study includes a mandibular positioner to determine an optimal titration position based on inputs of airflow and an oxygen desaturation index (ODI) of less than 10 events per hour. The device analyses the collected information and generates a report to assist the Healthcare Provider in the clinical management of oral appliance therapy for patients with mild to moderate obstructive sleep apnea.”
AlgorithmPhysiological Closed-Loop Controlled (PCLC) medical device; trained binary classifier
source quote (p.7)
“The MATRx plus device is considered a Physiological Closed-Loop Controlled (PCLC) medical device. The predication was done using a trained binary classifier.”
Adaptive (vs locked)Yes
source quote (p.11)
“The participant then fell asleep and the device adjusted the position of the mandible in response to changes in detected airflow and oximetry according to the device's control algorithms. The following morning, the participant removed the titration trays and other sensors and terminated the program. The night's data were used by the system to determine the parameters for the subsequent night's settings, for a total of up to six nights.”
PCCPNo
Cybersecurity addressedYes
source quote (p.6)
“Software validation and verification testing demonstrated that the device met its design, implementation, and cybersecurity requirements.”

Validation studies (2)

Bench

sample size not stated

endpoints: Accuracy Data; Force Limit Test; Device Force Limitation Simulation; Impression material breakage

standards: IEC 60601-1-10, IEC 60601-1-2:2014, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-8, IEC 61000-4-6, IEC 61000-4-11, IEC 61000-3-2, IEC 61000-3-3, FCC 47 CFR Part 15, Subpart B, CISPR 11, Group 1, Class B, IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 +CORR. 2:2007 + A1:2012, ETSI EN 300 328 v1.8.1, ETSI EN 301 489-1 v1.9.2, ETSI EN 301 489-17 v2.2.1, AAMI TIR69:2017, FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” issued May 11, 2005

Retrospective clinical

n=60 patients

endpoints: Predictive Accuracy; Safety; Usability

standards: FDA Guidance Document “Applying Human Factors and Usability Engineering to Medical Devices” issued February 3, 2016

Reported performance (4 observations)

sensitivity94.2CI 0.86-1.00
source quote (p.12)
“Sensitivity 94.2 Lower Confidence Limit 0.86 Upper Confidence Limit 1.00”
specificity75CI 0.40-1.00
source quote (p.12)
“Specificity 75.0 Lower Confidence Limit 0.40 Upper Confidence Limit 1.00”
ppvas written: “Positive Predictive Value”96.1CI 0.88-1.00
source quote (p.12)
“Positive Predictive Value 96.1 Lower Confidence Limit 0.88 Upper Confidence Limit 1.00”
npvas written: “Negative Predictive Value”66.7CI 0.34-1.00
source quote (p.12)
“Negative Predictive Value 66.7 Lower Confidence Limit 0.34 Upper Confidence Limit 1.00”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Dental panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN170090