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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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(129 days)
The device is indicated for use by the Health Care Professional (HCP), where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of a HCP.
The MATRx plus is a new ventilatory effort recorder device. The MATRx plus recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation, snoring and body position during sleep. The physician prescribed 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 Health Care Professional (HCP) prior to deploying the device to the patient for use in the home. The Tablet runs the MATRx plus application according to the selected study type, 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.
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.
The Zephyr Sleep Technologies MATRx plus device, a ventilatory effort recorder for aiding in the diagnosis and assessment of sleep-disordered breathing in adult patients, underwent bench testing and performance comparisons to demonstrate substantial equivalence to its predicate device, the ApneaLink Air (K143272).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for clinical performance metrics (like sensitivity, specificity for diagnosing sleep-disordered breathing). Instead, it focuses on demonstrating technological equivalence to the predicate device and satisfactory performance in bench testing.
Therefore, the table below reflects the comparison of technological characteristics between the MATRx plus and its predicate device, ApneaLink Air, as presented in the submission. The acceptance criterion is implicit: the MATRx plus should be "substantially equivalent" in its performance and features to the predicate device.
| Feature / Criterion | Acceptance Criteria (Implicit: Substantially Equivalent to ApneaLink Air K143272) | Reported Device Performance (MATRx plus) | Comments on Equivalence |
|---|---|---|---|
| Intended Use | Aid in diagnosis of sleep disordered breathing for adult patients. Records nasal airflow, snoring, SpO2, pulse, resp effort, body position. | Aid in diagnosis and assessment of sleep disordered breathing for adult patients. Records nasal airflow, snoring, SpO2, pulse, resp effort, body position. | Substantially Equivalent (MATRx plus includes "assessment" in addition to "diagnosis"). |
| Environment of Use | Deployed from Clinics, Hospitals; Used unsupervised in Home or Clinic; Analyzed from physician's office. | Deployed from Clinics, Hospitals; Used unsupervised in Home or Clinic; Analyzed from physician's office. | Equivalent. |
| Outcome | Data to aid in the diagnosis of sleep disordered breathing. | Data to aid in the diagnosis of sleep disordered breathing. | Equivalent. |
| Contraindications | Not for use near MRI. | Not for use near MRI; Not an apnea monitor or for life-supporting situations; Not for use by persons under 18. | Substantially Equivalent (MATRx plus has additional safety contraindications). |
| Oximeter Sensor | Third-party sensor (Nonin Xpod 3012 LP), 1 Hz sampling. | Third-party sensor (Masimo SET 2040), 1 Hz sampling. | Substantially Equivalent. |
| Airflow Sensor | Single channel nasal cannula, 100 Hz sampling for pressure, airflow, snoring. | Dual channel nasal cannula, 350 Hz sampling for pressure, airflow, snoring. | Substantially Equivalent - Dual channel can reduce artifact. |
| Respiratory Effort Sensor | Pneumatic principle, 10 Hz sampling. | Inductance principle (third-party belt Sleep Sense, K042253), 25 Hz sampling. | Substantially Equivalent - Both are commonly used and sensitive enough. |
| Position Sensor | 3D axis accelerometer. | 3D axis accelerometer. | Substantially Equivalent. |
| Snoring Detection | Nasal airflow fluctuation envelope (10-60 Hz), user adjustable threshold. | Nasal airflow fluctuation envelope (10-70 Hz), set threshold. | Substantially Equivalent. |
| Recorder Dimensions | Approx. 2.4" x 4" x 1.2" (predicate). | Approx. 2.48" x 3.11" x 0.83" (MATRx plus). | Substantially Equivalent - Compared to reference device (K021176) at 2.5"x4.5"x1.2". |
| Recorder Weight | 66 g (predicate). | 230 g (MATRx plus). | Substantially Equivalent - Compared to reference device (K021176) at 234g. |
| Data Collection | Sensors direct to recorder, stored on recorder, uploaded via USB post-study. | Sensors direct to recorder, wirelessly transferred (Bluetooth) to tablet, stored on tablet, wirelessly uploaded to web portal post-study. | Substantially Equivalent - Bluetooth connectivity comparable to Nox T3 (K082113). Allows earlier data review. |
| Processor | ARM Cortex M3 based LPC1853. | ARM Cortex M4 based, STM32 F4, 168 MHz; Tablet minimum requirements: 1.33 GHz, 1 GB RAM. | Substantially Equivalent - MATRx plus includes a tablet for data storage and user interaction. |
| Indicators | Via LED: Test Complete, Respiratory Flow. | Via Tablet UI: Test Started, Test Paused, Test Complete, Respiratory Flow, Oximetry Connection, Effort Sensor Connection, Battery Charge. | Substantially Equivalent - Additional feedback provided by MATRx plus (via tablet). |
| Recording Time | 4 x 12 hours. | 6 x 8 hours. | The total number of study hours in the MATRx plus is set by the software. |
| Internal Memory | 48 hours. | 48 hours (reported); > 100 hours (comment). | Substantially Equivalent. |
| Patient Set-up | On device software, transferred via USB. | On device software, transferred via internet. | Substantially Equivalent - Removal of USB port to increase cybersecurity. |
| Data Storage and Access | Stored and accessible via local database. Copies downloaded locally. | Stored and accessible via manufacturer's secure internet-accessible server. Copies downloaded locally. | Substantially Equivalent. |
| Data Analysis (Indices) | AHI, RI, Apnea Index (various), Hypopnea Index, flow limited breaths, Cheyne-Stokes, ODI, various saturations, various pulse rates. | ODI, Average Saturation, minimum saturation, maximum saturation, min pulse rate, max pulse rate, average pulse rate. (Does NOT calculate AHI, RI, Apnea Index, Hypopnea Index, flow limited breaths, Cheyne-Stokes). | Substantially Equivalent - Raw data available for manual calculation of uncalculated parameters. |
| Biocompatibility | Cleared under K131932. | All body contacting components previously cleared (Nasal Cannula K151506; Oximeter sensor K051212, K090662, K101896). | Substantially Equivalent. |
| Safety Testing | IEC 60601-1-11: 2010; IEC 60601-1-2:2007; IEC 60601-1:2005. | (Implied equivalent; states "Design and system verification testing included... mechanical and environmental testing according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005+1 and EMC testing according to IEC 60601-1-2:2007 has been performed.") Rechargeable battery tested to IEC 62133:2012. | Equivalent. |
2. Sample size used for the test set and the data provenance
The document mentions validation of the "Autoscoring algorithm for ODI" (Oxygen Desaturation Index) by comparing its output with the Snore SAT monitor (K002159).
- Test Set Sample Size: 179 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's mentioned as "data from 179 patients" when comparing the autoscoring algorithm. The study appears to be retrospective, using existing data for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states: "Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients."
- This implies that the "ground truth" for the ODI autoscoring comparison was the output of the Snore SAT monitor (K002159).
- The document does not specify the number of human experts, their qualifications, or their role in establishing this ground truth for the test set. It relies on the predicate device's (or reference device's) established output as the comparative standard.
4. Adjudication method for the test set
Not applicable. The ground truth for the ODI autoscoring was based on the output of a previously cleared device (Snore SAT monitor), not on human consensus or adjudication in this specific context.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned for the MATRx plus. The submission focuses on demonstrating substantial equivalence to a predicate device through technological comparison and bench testing, not on assessing human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done for the Autoscoring algorithm for ODI.
- "Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients."
- This suggests the MATRx plus's algorithm-driven ODI calculation was directly compared to the output of a reference device without human interpretation as part of this specific comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the ODI autoscoring algorithm validation, the ground truth was the output of a legally marketed predicate/reference device, the Snore SAT monitor (K002159). This is a form of "reference device data" ground truth, not pathology, expert consensus, or outcomes data in this specific study.
8. The sample size for the training set
The document does not provide information on the sample size used for training any algorithms within the MATRx plus device. The focus of this 510(k) summary is on demonstrating equivalence, not on detailing algorithm development and training.
9. How the ground truth for the training set was established
Not provided in the document. As no information on the training set is included, the method for establishing its ground truth is also absent.
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