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510(k) Data Aggregation
(245 days)
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.
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.
Here's a structured breakdown of the acceptance criteria and the study that proves the MATRx plus device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Clinical Endpoints
| Acceptance Criteria Category | Specific Acceptance Criteria (Effectiveness, Safety, Usability) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Effectiveness | 1. Predictive Accuracy (Primary Endpoint): Sensitivity and specificity statistically significant to reject the null hypothesis that sensitivity ≤0.6. | Sensitivity: 94.2% (95% CI: 0.86 – 1.00) |
| Specificity: 75.0% (95% CI: 0.40 – 1.00) | ||
| 2. Target Protrusive Position (Secondary Endpoint): Statistically significant to reject the null hypothesis that target accuracy ≤0.6. | Identification of Efficacious Target Protrusion: 86.3% of participants were correctly predicted as responders and successfully provided with an effective target protrusion. | |
| Safety | No significant safety concerns reported by coordinator, dentist, or participant. | No significant safety concerns reported. Adverse events were temporary discomfort (in teeth, joint, jaw, minor gum irritations, temporary bite changes, soreness in teeth) that resolved within a few hours. |
| Only minor discomfort reported on post-study questionnaires. | Temporary discomfort reported (resolved within hours). | |
| No software failure resulting in injury. | No software failure reported that resulted or could result in injury. | |
| No movement beyond full retrusion and maximum protrusion set values. | No movement beyond full retrusion and maximum protrusion set values reported. | |
| Usability | Accurate prediction for OA therapy and effective titration level demonstrated by actual use testing (setup, placement, use, removal by participant in home). | Human factors assessment conducted as part of the clinical trial showed participants and providers evaluated for comprehension-based tasks. The study supported usability. |
Bench Performance Testing
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|---|
| 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. | The data provided showed each test was passed according to its pre-specified acceptance criteria. |
| 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. | The data provided showed each test was passed according to its pre-specified acceptance criteria. |
| 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). | The data provided showed each test was passed according to its pre-specified acceptance criteria. |
| Impression Material Breakage | 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. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Study: The document provides "49" for "Successful Identification of Responders" and "2" for "Failure to Identify Responders" in the "Predictive Success Category," and "3" for "Successful Identification of Responders" and "6" for "Failure to Identify Responders" in the "Predictive Failure Category." This totals 49 + 2 + 3 + 6 = 60 participants in the mild to moderate OSA population for the effectiveness endpoints.
- Human Factors: 15 patients were recruited for each study.
- Data Provenance: The MATRx plus is by Zephyr Sleep Technology, located in Calgary, Alberta, Canada. The clinical study was conducted in a clinical setting (dental professional's office for deployment, home environment for use). The study is prospective, as it involved recruiting participants, conducting the MATRx plus study, and then following up with custom oral appliance therapy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts:
- Effectiveness Ground Truth (Oral Appliance Outcome): While not explicitly stated how many individual experts reviewed each case, the process involved a "Sleep Health professional" reviewing baseline HSAT data and a "licensed dentist" conducting intraoral exams and subjective interviews post-study. The final determination of "successful treatment with an oral appliance" (ODI
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