(245 days)
Not Found (This is a De Novo classification)
No
The description mentions "feedback control" and "analyses the collected information and generates a report," but there is no explicit mention of AI, ML, or related terms like neural networks, deep learning, or algorithms that typically characterize AI/ML applications in medical devices. The analysis appears to be based on predefined criteria (ODI
No
Explanation: The device is described as an assessment tool to identify suitable candidates for oral appliance therapy and recommend a target mandibular position, rather than providing direct therapy itself. It specifically states that it "does not replace the clinical titration process or the need for follow-up testing to determine the initial and ongoing therapy."
Yes
The "Intended Use / Indications for Use" section states: "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 therapy with an oral appliance and to recommend a target mandibular position." This clearly indicates the device is used to identify a condition (obstructive sleep apnea suitability for therapy) and inform treatment, which are characteristics of a diagnostic device.
No
The device description explicitly lists hardware components including a recorder, tablet, oximeter, effector belt, nasal cannula, and a mandibular positioner.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The description of the MATRx plus device clearly states that it is an automated temporary oral appliance that manipulates the mandible and records changes in respiratory status during an overnight sleep study. It uses inputs like airflow and oxygen desaturation index. These are physiological measurements taken directly from the patient, not analyses of biological specimens (like blood, urine, tissue, etc.).
- The device's function is to assess physiological responses and recommend a treatment parameter. The device's purpose is to identify patients suitable for oral appliance therapy and recommend a target mandibular position based on their respiratory response to mandibular repositioning. This is a functional assessment of the patient's physiology in response to a physical manipulation, not a diagnostic test performed on a biological sample.
While the device is used to assist in the clinical management of a condition (obstructive sleep apnea), its mechanism of action and the data it collects do not align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 therapy with an oral appliance 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.
Product codes (comma separated list FDA assigned to the subject device)
QCJ
Device Description
This De Novo request is for an expanded indication (new intended use) for use 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. 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. From this report, patients may be informed on the future efficaciousness of oral appliance (OA) therapy.
Specifically, the clinical management may be assisted by this type of oral appliance assessment study by prospectively identifying patients that are expected to achieve therapeutic success with oral appliance therapy. The oral appliance assessment study also includes the provision of a recommended target protrusive setting for the mandible through use of a legally marketed intraoral appliance (regulated under 21 CFR 872.5570, product code LQZ). The target protrusive setting is the amount of mandibular protrusion where the patient is expected to achieve efficacious therapy with the intraoral appliance and is used by the HCP to more effectively complete the titration process.
The use of the MATRx plus device for an oral appliance assessment study does not replace the clinical titration process or the need for follow-up testing to determine the initial and ongoing therapy as recommended by clinical practice guidelines.
The MATRx plus test identifies patients as suitable for intraoral therapy if a mandible protrusion level can be found where the patient has an oxygen desaturation index (ODI) of less than 10 events per hour with a 4% desaturation criterion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The predication was done using a trained binary classifier.
Input Imaging Modality
Not Found
Anatomical Site
Mandible, mouth
Indicated Patient Age Range
Between 21 and 80 years
Intended User / Care Setting
Healthcare Provider (HCP), home use device, dental professional's office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical study was completed in two phases. Phase I used a prototype of the device and established proof of concept ahead of Phase II. This review focuses on Phase II, as it is pivotal, uses the final finished device, and includes a human factors assessment. The device was used as intended, unattended in the home environment following deployment from a dental professional's office.
Individuals previously diagnosed with or treated for OSA were recruited for the study. Only the mild to moderate population was used in the final evaluation. The gender distribution, age, and BMI of the study population was representative of the general population of individuals with obstructive sleep apnea.
Inclusion Criteria
-
- Aged between 21 and 80 years
-
- Obstructive sleep apnea (only mild to moderate OSA patients' data were used)
-
- Oxygen Desaturation Index > 10 hr-1
-
- Body mass index less than 45 kg/m2
-
- Neck circumference less than 50 cm
-
- Absence of severe oxyhemoglobin desaturation during sleep as indicated by a mean SaO2 value greater than 87%
-
- Mandibular range of motion greater than 5 mm
-
- Adequate dentition (10 upper and 10 lower teeth)
-
- Ability to understand and provide informed consent
-
- Ability and willingness to meet the required schedule
Exclusion Criteria
-
- Inability to breathe comfortably through the nose
-
- Anticipated change in medical therapy that could alter the severity of OSA during the protocol
-
- Anticipated change in body weight (5% or more) during the protocol
-
- Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome or chronic insomnia
-
- Severe respiratory disorder(s) other than sleep disordered breathing
-
- Loose teeth or advanced periodontal disease
-
- Participation in other studies that could interfere with study protocol
-
- Pregnant or nursing (added in phase II)
-
- Heart failure (added in phase II)
-
- Cerebral vascular incident within the last 12 months (added in phase II)
-
- Use of pacemaker or other life supporting device (added in phase II)
Each participant received a two-night baseline, pretreatment, respiratory evaluation in the home using a legally marketed home sleep recorder set to measure 4% oxygen desaturations (Phase I: Snore SAT, K002159; Phase II: MATRx plus, K163665) to determine the presence and severity of obstructive sleep apnea. The baseline study with the Home Sleep Apnea Test was used, in part, to determine eligibility for the MATRx plus study. All baseline data were reviewed by a Sleep Health professional.
Each participant was then evaluated by the dental co-investigator for adequate dentition and other dental criteria. Participants were fitted with upper and lower Titration Trays filled with impression material. The dentist measured the maximum retrusion, normal bite, and protrusion values from the scale on the MATRx plus titration trays. On the first night of the home MATRx plus oral appliance assessment study, the values provided by the dentist for normal bite, retrusion, and protrusion were entered into the software by a technician and used to control the limits of protrusion.
The participants then performed the MATRx plus OA assessment study over a two- or three-night sequence in their own home with no attendant present. At bedtime, the participant independently applied the nares cannula and the finger oximeter, inserted the trays into the mouth and initiated the study. This included establishing the Bluetooth pairing and connecting the sensors to the device, and wearing a respiratory effort belt. 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.
If any of the study nights were incomplete (i.e., less than 4 hours of usable data) the incomplete study night was repeated if the participant was willing. Post-study, the data were reviewed to verify that the device was set up and used properly. Following each study night, the participant completed a safety-related questionnaire in which additional factors relating to the safety (e.g., ease of applying and removing the trays, pain and discomfort, oral obstruction, tray retention, ability to understand alerts, etc.) was recorded. At the end of the complete study, the participant completed additional questions related to the use of the device (e.g., ease of ending the study, difficulty in positioning trays, overall opinion of the device, ability to understand notifications and instructions, etc.). A coordinator interviewed the participants on the results of the questionnaire. A licensed dentist completed an intraoral exam to inspect for any adverse events. The exam was performed within five days of the study and a separate subjective interview was conducted to gather additional information by the dentist related to dental safety, ease of use, comfort and adverse events.
After the completion of the MATRx plus study, the data were automatically analyzed, and the participants labeled as either: 1) predicted success (responder); or 2) predicted failure (non-responder). If insufficient data on which to base a prediction were attained, i.e., less than four hours of sleep on a study night on the required nights, the participant was labeled inconclusive. The predication was done using a trained binary classifier. The test also provided a predictive target protrusive position for participants labeled as predicted responders. Once the target protrusive value was obtained, the protrusion level was transferred to the patient's final oral appliance and was tested as per the sponsor's success criteria with the MATRx Home Sleep Apnea test, which has been validated for using the Oxygen Desaturation Index (ODI).
A successful MATRx plus study was defined as an ODI of less than 10, where ODI is measured as the number of oxygen desaturation events of 4% or greater per hour. If the success criteria were not achieved at the target position, the participant's oral appliance was advanced, and the participant was retested at 1 mm increments from target until the participant was found to be a therapeutic success (ODI
§ 872.5571 Auto titration device for oral appliances.
(a)
Identification. An auto-titration device for oral appliances is a prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate the following:
(i) Performance characteristics of the algorithm; and
(ii) All adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
(i) Validation of the closed loop algorithm;
(ii) Mechanical integrity over the expected use life;
(iii) Characterization of maximum force, distance, and speed of device movement; and
(iv) Movement accuracy of intraoral components.
(3) Performance testing must demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Performance data must validate the reprocessing instructions for any reusable components.
(7) Patient labeling must include:
(i) Information on device use, including placement of sensors and mouthpieces;
(ii) A description of all alarms; and
(iii) Instructions for reprocessing any reusable components.
(8) A human factors assessment must evaluate simulated use of the device in a home use setting.
0
DE NOVO CLASSIFICATION REQUEST FOR MATRx plus
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Auto titration device for oral appliances: An auto-titration device for oral appliances is a prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea.
NEW REGULATION NUMBER: 21 CFR 872.5571
CLASSIFICATION: Class II
PRODUCT CODE: QCJ
BACKGROUND
DEVICE NAME: MATRx plus
SUBMISSION NUMBER: DEN170090
DATE OF DE NOVO: December 21, 2017
- CONTACT: Zephyr Sleep Technology #102, 701 64th Ave SE Calgary, Alberta Canada T2H 2C3
INDICATIONS FOR USE
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 therapy with an oral appliance 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.
1
LIMITATIONS
Prescription use only.
In an Oral Appliance Study mode, the device is not recommended for use in patients who:
- . Have loose teeth or advanced periodontal disease
- . Have full dentures or dental implants
This device is not to be used as an apnea monitor or in a life supporting or life sustaining situation.
Warnings
Patients fitted with an oral appliance after their MATRx plus Study, as prescribed by the interpreting physician, should be monitored and undergo further sleep testing with their therapeutic appliance in place to ensure adequate treatment is achieved.
Use of the device during an Oral Appliance Study may cause:
- · Temporary bite changes
- Gum or tooth discomfort
- Jaw discomfort
- Jaw joint discomfort
- Increased salivation
- Dry mouth
Use of the MATRx plus may cause disruption in sleep from the use of the sensors and mandibular positioner.
Inspect the titration trays and tray material carefully prior to each use. Stop the study and return the system to the provider if:
- The tray material has degraded
- · The tray material has come off the Titration Trays during the study. If this occurs, remove any pieces from the mouth
- · The titration trays are uncomfortable due to the tray material
Use of the titration trays is not to exceed 3 nights of sleep (total 24 hours).
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
This De Novo request is for an expanded indication (new intended use) for use 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.
2
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. From this report, patients may be informed on the future efficaciousness of oral appliance (OA) therapy.
Specifically, the clinical management may be assisted by this type of oral appliance assessment study by prospectively identifying patients that are expected to achieve therapeutic success with oral appliance therapy. The oral appliance assessment study also includes the provision of a recommended target protrusive setting for the mandible through use of a legally marketed intraoral appliance (regulated under 21 CFR 872.5570, product code LQZ). The target protrusive setting is the amount of mandibular protrusion where the patient is expected to achieve efficacious therapy with the intraoral appliance and is used by the HCP to more effectively complete the titration process.
The use of the MATRx plus device for an oral appliance assessment study does not replace the clinical titration process or the need for follow-up testing to determine the initial and ongoing therapy as recommended by clinical practice guidelines.
The MATRx plus test identifies patients as suitable for intraoral therapy if a mandible protrusion level can be found where the patient has an oxygen desaturation index (ODI) of less than 10 events per hour with a 4% desaturation criterion.
Device Components
The components of the MATRx plus device for use in a titration study, are shown below in Figure 1:
3
Figure 1: MATRx Plus Device Components
Image /page/3/Figure/1 description: The image shows a collection of medical devices and equipment. There is a tablet displaying a welcome screen for "MATRx plus" by Zephyr Sleep Technologies. Other items include a recorder, mandibular positioner with titration trays, an effort belt, a nasal cannula, and an oximeter.
The MATRx plus comprises the following components that were previously cleared under premarket notifications (510(k)s):
- Body Worn Recorder (with accelerometer sensor) [510(k) #K163665]
- Tablet computer that runs the MATRx plus Application [510(k) #K163665] ●
- . Study Management and Review Software (Portal and Data Viewer) [510(k) #K163665]
- Nasal Cannula [510(k) #K163665] ●
- Respiratory Effort Belt [510(k) #K163665] ●
- Sleep Sense Impendence Belt [510(k) #K042253, not pictured in Figure 1]
- Oximeter Sensors [510(k) #K101896, K051212, K090662]
- Vinyl Polysiloxane 2 Component Vulcanizing System [K930248, not pictured in Figure 1]
- . Titration Trays (same material as in K103704)
- Mandibular Positioner (similar to that cleared in K103704)
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The MATRx plus Recorder, Tablet, Nasal Cannula, Respiratory Effort Belt and Finger Oximeter were previously cleared for the use of the MATRx plus device as a sleep recorder (K163665). There have been no changes to these devices, or their use (type or duration of contact) as part of this product. Biocompatibility for these components was demonstrated in 510(k) #K163665.
The MATRx plus Titration Tray and Impression material are of the same material and contact as the Titration Tray and Impression material for the in-lab version of the device (MATRx, K103704). Type and duration of contact remain the same (95% drop, 5s |
| Radiated Disturbance | FCC 47 CFR Part 15, Subpart B
CISPR 11, Group 1, Class B | |
| Conducted Disturbance | CISPR 11, Group 1, Class B | |
| RF Emissions | IEC 61000-3-2 Harmonics
IEC 61000-3-3 Flicker | |
Table 1: Electromagnetic Compatibility (EMC) Safety Tests
With the exception of FCC 47 CFR Part 15, all the other standards are normative references of IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General
5
requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests and conform to IEC 60601-1-2:2014
The MATRx plus was tested in accordance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 +CORR. 2:2007 + A1:2012 and passed the following wireless safety and radio frequency wireless coexistence safety tests:
| Basic EMC Standard | Test Name | |
|---|---|---|
| ETSI EN 300 328 v1.8.1 | Wireless Safety Test | Electromagnetic compatibility and Radio |
| spectrum Matters (ERM) | ||
| ETSI EN 300 328 v1.8.1 | Wireless Safety Test | Wideband transmission systems |
| ETSI EN 300 328 v1.8.1 | Wireless Safety Test | Data transmission equipment operating in |
| the 2,4 GHz ISM band and using wide band | ||
| modulation techniques | ||
| ETSI EN 300 328 v1.8.1 | Wireless Safety Test | Harmonized ENcovering the essential |
| requirements of article 3.2 of the R&TTE | ||
| Directive | ||
| ETSI EN 301 489-1 v1.9.2 | Wireless Safety Test | Electromagnetic compatibility and Radio |
| spectrum Matters (ERM) | ||
| ETSI EN 301 489-1 v1.9.2 | Wireless Safety Test | ElectroMagnetic Compatibility (EMC) |
| standard for radio equipment and services; | ||
| Part 1: Common technical requirements | ||
| ETSI EN 301 489-17 v2.2.1 | Wireless Safety Test | Electromagnetic compatibility and Radio |
| spectrum Matters (ERM) | ||
| ETSI EN 301 489-1 v1.9.2 | Wireless Safety Test | ElectroMagnetic Compatibility (EMC) |
| standard for radio equipment Part 17: | ||
| Specific conditions for Broadband Data | ||
| Transmission Systems | ||
| AAMI TIR69:2017 | Radio frequency wireless | |
| coexistence safety test | Risk management of radio-frequency | |
| wireless coexistence for medical devices | ||
| and systems |
| Table 2: Wireless Safety and Radio Frequency Wireless Coexistence Safety Tests | |||
|---|---|---|---|
MAGNETIC RESONANCE (MR) COMPATIBILITY
The device has not been tested for MRI compatibility and should not be used in the vicinity of an MRI device.
SOFTWARE
The De Novo request provided adequate software documentation consistent with a "Moderate" level of software concern as discussed in the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005.
Software validation and verification testing demonstrated that the device met its design, implementation, and cybersecurity requirements.
HUMAN FACTORS
A human factors assessment was conducted as part of the clinical trial for the MATRx
6
plus device. Please refer to the 'Summary of Clinical Information' below.
PERFORMANCE TESTING - CLOSED LOOP ALGORITHM
The MATRx plus device is considered a Physiological Closed-Loop Controlled (PCLC) medical device. The sponsor has provided a conformity report to the following consensus standard:
IEC 60601-1-10 The General requirements for basic safety and essential performance -Collateral Standard: Requirements for the development of physiologic closed-loop controllers.
The sponsor has adequately addressed the following elements in the closed-loop system :
- Control scheme and method
- Rationale for choice of controller ●
- Control parameters (e.g., Proportional and Integral (PI) gains) ●
- Control variables (e.g., infusion rate) .
- Controller robustness (i.e., against patient variability). .
- . Controller stability
- Details of signal processing that enable the feedback system and how different . sensors (e.g. oximeter and flow sensor) are combined to inform the positioner controller
- Sensor accuracy variability and potential detrimental effects on the positioner ●
- Reliability of the sensor in situations that may pose disturbance to the reading . (e.g., patient movement)
PERFORMANCE TESTING - BENCH
The following testing was reviewed as a part of the bench performance testing:
| Test | Test Objectives |
|---|---|
| Mandibular | |
| Positioner, | |
| Accuracy Data | (i) Device will be able to send a position feedback signal to the |
| controller that reports a new position within 0.5mm of the | |
| actual physical position of the trays/mandible; and the accuracy | |
| will be maintained under expected clinical loads. | |
| (ii) The mandibular positioner will be able to physically endure | |
| the use life of the device under normal operating load without | |
| failure and maintain the accuracy. Simulated use life testing | |
| was conducted based on days of single patient use, movements | |
| per patient use, and approximated number of insertion and | |
| removal cycles per patient use. This number was extrapolated | |
| for the final use life determination, and testing was conducted | |
| at this value. |
Table 3: Bench Performance Testing
7
| Mandibular
Positioner, Force
Limit Test | Mandibular positioner will be incapable of applying a force that
could induce serious injury under a worst-case fault scenario of
70 Newtons as reported in the literature. This is a force that the
average patient should be able to voluntarily counteract by
resisting anterior/posterior motion or clenching. The literature
supported forces in a range of 150N or more, therefore, a
conservative acceptance criteria has been established. |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Force
Limitation
Simulation | (i) Demonstrate the ability of users to voluntarily stall the
mandibular positioner in a fault position (i.e., full stroke speed)
(ii) Demonstrate that without voluntary action to resist the
force, the trays dislodge from their seated position on the teeth
prior to injury or maximum force (i.e., 70N) |
| Impression
material
breakage | (i) Demonstrate the ability of the impression material used to
form the temporary oral appliance to maintain integrity over the
use life of the temporary oral appliance |
The data provided showed each test was passed according to its pre-specified acceptance criteria.
SUMMARY OF CLINICAL INFORMATION
Objective
To evaluate the ability the MATRx plus to safely and effectively identify which patients with obstructive sleep apnea are expected to achieve therapeutic success with oral appliance therapy and to recommend an efficacious target mandibular position at which intraoral therapy may be effective.
Study Design
The clinical study was completed in two phases. Phase I used a prototype of the device and established proof of concept ahead of Phase II. This review focuses on Phase II, as it is pivotal, uses the final finished device, and includes a human factors assessment. The device was used as intended, unattended in the home environment following deployment from a dental professional's office.
Human Factors
Human factors verification and validation testing was also evaluated as part of the pivotal clinical trial. The study provided a human factors assessment as per the FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices" issued February 3, 2016.
As per the guidance, 15 patients were recruited for each study which were conducted in a bedroom environment. Each patient had been previously diagnosed with OSA. Participants and providers were evaluated for comprehension-based tasks.
The human factors evaluation included the following:
- Simulated device set-up of the portal and tablet device set up, tray fabrication, patient ● self-insertion of trays, and reprocessing
8
- Actual use testing- actual patient overnight use, technician reading and understanding the ● report
Clinical Endpoints
Effectiveness
-
- Predictive Accuracy
Successful treatment with an oral appliance was defined prospectively as achieving an oxygen desaturation index (ODI) with the custom appliance, by the automated analysis of a full night home sleep test, of less than 10 desaturation events per hour. Unsuccessful treatment with an oral appliance was defined as achieving an ODI on the home sleep test greater than or equal to 10 desaturation events per hour.
- Predictive Accuracy
-
The MATRx plus predictive accuracy endpoint was assigned if the sensitivity and . specificity was found to be statistically significant to reject the null
hypothesis that sensitivity was ≤0.6 -
A secondary outcome was assigned if the MATRx plus target protrusive position . was found to be statistically significant to reject the null hypothesis that target
accuracy was ≤0.6 -
- Safety
The pivotal study success criteria are as follows:
- Safety
-
No significant safety concerns reported by the coordinator, dentist, or participant. ●
-
Only minor discomfort reported on the MATRx plus post-study device participant . questionnaires.
-
No failure of the software that resulted or could result in injury to the participant . if it were to recur.
-
No movement beyond full retrusion and maximum protrusion set values. ●
-
- Usability
- The MATRx plus usability endpoint was assigned if usability testing of the device ● produced an accurate prediction for oral appliance therapy and effective titration level as demonstrated by actual use testing relating to the set-up, placement, use, and removal of the device by the participant in the home environment
Statistical Methodology
The predictive accuracy endpoint for the study was determined by calculating the sensitivity and specificity of the predictions made from the MATRx plus test, where 95% confidence intervals were obtained using 1-sided binomial calculations, which were sufficient to reject the null hypothesis that sensitivity was ≤0.6. A secondary predictive accuracy outcome was assigned if the MATRx plus target protrusive position was found to be statistically significant, where 95% confidence intervals were obtained using 1-sided binomial test calculations, which were
sufficient to reject the null hypothesis that target accuracy was ≤0.6.
9
Participant Selection
Individuals previously diagnosed with or treated for OSA were recruited for the study. Only the mild to moderate population was used in the final evaluation. The gender distribution, age, and BMI of the study population was representative of the general population of individuals with obstructive sleep apnea.
Inclusion Criteria
-
- Aged between 21 and 80 years
-
- Obstructive sleep apnea (only mild to moderate OSA patients' data were used)
-
- Oxygen Desaturation Index > 10 hr-1
-
- Body mass index less than 45 kg/m2
-
- Neck circumference less than 50 cm
-
- Absence of severe oxyhemoglobin desaturation during sleep as indicated by a mean SaO2 value greater than 87%
-
- Mandibular range of motion greater than 5 mm
-
- Adequate dentition (10 upper and 10 lower teeth)
-
- Ability to understand and provide informed consent
-
- Ability and willingness to meet the required schedule
Exclusion Criteria
-
- Inability to breathe comfortably through the nose
-
- Anticipated change in medical therapy that could alter the severity of OSA during the protocol
-
- Anticipated change in body weight (5% or more) during the protocol
-
- Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome or chronic insomnia
-
- Severe respiratory disorder(s) other than sleep disordered breathing
-
- Loose teeth or advanced periodontal disease
-
- Participation in other studies that could interfere with study protocol
-
- Pregnant or nursing (added in phase II)
-
- Heart failure (added in phase II)
-
- Cerebral vascular incident within the last 12 months (added in phase II)
-
- Use of pacemaker or other life supporting device (added in phase II)
Study Procedure
Each participant received a two-night baseline, pretreatment, respiratory evaluation in the home using a legally marketed home sleep recorder set to measure 4% oxygen desaturations (Phase I: Snore SAT, K002159; Phase II: MATRx plus, K163665) to determine the presence and severity of obstructive sleep apnea. The baseline study with the Home Sleep Apnea Test was used, in part, to determine eligibility for the MATRx plus study. All baseline data were reviewed by a Sleep Health professional.
Each participant was then evaluated by the dental co-investigator for adequate dentition and other dental criteria. Participants were fitted with upper and lower Titration Travs filled with impression material. The dentist measured the maximum retrusion, normal bite, and protrusion values from the scale on the MATRx plus titration trays. On the first night of the home MATRx plus oral appliance assessment study, the values provided by the dentist for normal bite,
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retrusion, and protrusion were entered into the software by a technician and used to control the limits of protrusion.
The participants then performed the MATRx plus OA assessment study over a two- or threenight sequence in their own home with no attendant present. At bedtime, the participant independently applied the nares cannula and the finger oximeter, inserted the trays into the mouth and initiated the study. This included establishing the Bluetooth pairing and connecting the sensors to the device, and wearing a respiratory effort belt. 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.
If any of the study nights were incomplete (i.e., less than 4 hours of usable data) the incomplete study night was repeated if the participant was willing. Post-study, the data were reviewed to verify that the device was set up and used properly. Following each study night, the participant completed a safety-related questionnaire in which additional factors relating to the safety (e.g., ease of applying and removing the trays, pain and discomfort, oral obstruction, tray retention, ability to understand alerts, etc.) was recorded. At the end of the complete study, the participant completed additional questions related to the use of the device (e.g., ease of ending the study, difficulty in positioning trays, overall opinion of the device, ability to understand notifications and instructions, etc.). A coordinator interviewed the participants on the results of the questionnaire. A licensed dentist completed an intraoral exam to inspect for any adverse events. The exam was performed within five days of the study and a separate subjective interview was conducted to gather additional information by the dentist related to dental safety, ease of use, comfort and adverse events.
After the completion of the MATRx plus study, the data were automatically analyzed, and the participants labeled as either: 1) predicted success (responder); or 2) predicted failure (nonresponder). If insufficient data on which to base a prediction were attained, i.e., less than four hours of sleep on a study night on the required nights, the participant was labeled inconclusive. The predication was done using a trained binary classifier. The test also provided a predictive target protrusive position for participants labeled as predicted responders Once the target protrusive value was obtained, the protrusion level was transferred to the patient's final oral appliance and was tested as per the sponsor's success criteria with the MATRx Home Sleep Apnea test, which has been validated for using the Oxygen Desaturation Index (ODI).
A successful MATRx plus study was defined as an ODI of less than 10, where ODI is measured as the number of oxygen desaturation events of 4% or greater per hour. If the success criteria were not achieved at the target position, the participant's oral appliance was advanced, and the participant was retested at 1 mm increments from target until the participant was found to be a therapeutic success (ODI