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510(k) Data Aggregation
(103 days)
The MATRx plus is indicated for use by a lay person in the home and hospital use under the direction of a Health Care Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
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 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.
MATRx plus is a ventilatory effort recorder and closed loop auto-titration device for oral appliances. MATRx plus is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, snoring, respiratory effort, pulse rate, oxygen saturation, and body position during sleep.
The 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 healthcare professional (HCP) prior to deploying the device to the patient for home use. The Tablet runs the MATRx plus application and 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.
During an auto-titration study, the patient wears temporary Titration Trays connected to a mandibular positioner. During the study, the device moves the mandible in response to respiratory events in order to determine if the patient is a suitable candidate for oral appliance therapy.
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 (when used as a ventilatory effort recorder) or to assist the HCP in the clinical management of oral appliance therapy for patients with obstructive sleep apnea.
Here's a breakdown of the acceptance criteria and study information for the MATRx Plus device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance for the MATRx Plus (K191925) is based on demonstrating substantial equivalence to its predicate devices (K181996 and DEN170090), rather than explicit numerical acceptance criteria for clinical performance. The focus is on showing that the minor changes to the new MATRx Plus device do not alter its safety or effectiveness compared to the predicate MATRx Plus devices. Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the demonstration that the subject device meets the same performance standards.
| Feature/Performance Aspect | Acceptance Criterion (Implied by Predicate) | Reported Device Performance (Subject Device) | Discussion of Differences/Equivalence |
|---|---|---|---|
| Intended Use | Identical to predicate device | Identical to predicate device | Identical |
| Patient Population | Adults (Identical to predicate) | Adults (Identical to predicate) | Identical |
| Environment of Use | Deployed from clinics/hospitals, unsupervised in home/clinic, analyzed from physician's office (Identical to predicate) | Deployed from clinics/hospitals, unsupervised in home/clinic, analyzed from physician's office (Identical to predicate) | Identical |
| Outcome | 1) Data to assist in diagnosis of sleep disordered breathing; 2) Identifying patients with mild to moderate sleep apnea for whom an oral appliance is a suitable therapy (Identical to predicate). | 1) Data to assist in diagnosis of sleep disordered breathing; 2) Identifying patients with mild to moderate sleep apnea for whom an oral appliance is a suitable therapy (Identical to predicate). | Identical |
| Oximeter Sensor | Masimo SET 2040, 1 Hz sampling frequency (Predicate performance) | Masimo SET 2040D, 1 Hz sampling frequency (Functionally identical) | Functionally identical; oximeters have same technology and performance standards. Substantially equivalent. |
| Airflow Signal Alert | Predicate: Airflow signal absent for 90s alert | Subject Device: Airflow signal absent for 120s alert | No changes to airflow collection or analysis. Change to airflow alert in auto-titration study mode has no effect on data collected or test outcome. Substantially equivalent. |
| Mandibular Positioner Actuator Material | Acetal resin or anodized stainless steel (Predicate) | Acetal resin, anodized stainless steel, or anodized aluminum (Subject Device) | Identical aside from addition of anodized aluminum actuator. Mandibular positioner function is not affected by change to actuator material. Substantially equivalent. |
| Titration Trays Use Duration | Predicate: 24 hours | Subject Device: 6 nights (maximum duration allowed by tablet software) | The Titration Trays themselves are unchanged from the predicate. Additional biocompatibility and performance testing (in reference device K190051) demonstrated suitability for longer use. This change increases allowable test duration without changing tray design, thus substantially equivalent. |
| Titration Trays Fitting Personnel | Predicate: Qualified dentist or dental professional | Subject Device: Trained healthcare professional | The change to fitting of Titration Trays is supported by reference devices (e.g., Zyppah K182312) which are OTC oral appliances fitted by untrained individuals. Since a non-HCP fitting for an oral appliance has been cleared as safe and effective, the subject device's trays can similarly be fitted by a non-healthcare professional. Substantially equivalent. |
| Recorder Dimensions/Weight | 6.30 x 7.90 x 6.60 cm, 230 g (Predicate) | 11.0 x 8.0 x 3.5 cm, 166 g (Subject Device) | Subject device is smaller and lighter than predicate. Substantially equivalent. (Implies performance maintained) |
| Mandibular Positioner Dimensions/Weight | 5.2 x 5.7 x 2.8 cm, 80 g (Predicate) | 5.2 x 5.5 x 2.6 cm, 80 g (Subject Device) | Subject device is slightly smaller than predicate and the same weight. New design has been tested to ensure it meets the same performance criteria as predicate device. Substantially equivalent. |
| Battery Amperage | 5V - 2A medical grade wall power supply (Predicate) | 5V - 1A medical grade wall power supply (Subject Device) | Decrease in amperage leads to slightly increased charging time (5 h vs 4 h). Device is usable at 85% charge. Deemed negligible. Substantially equivalent. |
| Study Setup and Management | Setup on device software and transferred to Device via internet (Predicate) | Setup on device software and transferred to Device via internet. HCP may start new study directly on Tablet. HCP may opt to set up a study containing both study types (basic sleep study preceding or following auto-titration study). | HCP may continue to set up study in web Portal and load on Tablet or can alternatively start the study directly on the Tablet. No new functionality introduced (just change of function location). Addition of option for HCP to set up multiple studies for one patient removes the need for the device to be returned to the HCP between studies. Study types remain the same. Addition of risk that is mitigated by Tablet software. Substantially equivalent. |
| Reprocessing Instructions | (Original instructions) | Simplified instructions for reprocessing | No changes to reprocessing requirements. New instructions have been validated for cleaning and low-level disinfection. Substantially equivalent. |
| Biocompatibility | All body contacting components previously cleared | All body contacting components previously cleared. Titration Trays cleared for use up to 29 nights (in K190051) – allowed test duration changed from 3 to 6 nights. | Change to auto-titration test duration supported by biocompatibility testing on file for reference device (K190051). Substantially equivalent. |
| Other (Respiratory Effort, Position, Snoring, Data Collection, Processor, Indicators, Recording Time, Internal Memory, Battery Cover, Data Display, Data Reporting/Analysis - Indices Generated) | Identical to predicate | Identical to predicate | Identical |
| Safety Testing | Tested to IEC 60601-1, IEC 80601-2 | Tested to IEC 60601-1, IEC 80601-2 | Testing performed as necessary for subject device to demonstrate updated standards as predicate devices. Substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical performance testing was not required for the changes made to the subject device." This means there was no new clinical test set used for this specific 510(k) submission (K191925) to demonstrate the device meets acceptance criteria. The clearance relies on the existing clinical data and performance of the predicate devices (K181996 and DEN170090).
Therefore, details like sample size, data provenance (country of origin, retrospective/prospective) for a new clinical test set are not provided for this submission. The original predicate devices would have undergone such studies, but that information is not detailed here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no new clinical performance testing was conducted for this submission, there's no mention of experts establishing ground truth for a new test set. For the predicate devices, it's assumed appropriate medical experts (likely sleep specialists/physicians) would have been involved in establishing ground truth for their respective clinical studies.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical performance testing was performed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
Not applicable, as no new clinical performance testing was performed, and the device is a diagnostic/therapeutic aid, not an AI interpretation system requiring MRMC for reader improvement.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The regulatory submission focuses on the safety and performance changes of a medical device hardware and software update, not on a standalone algorithm's performance in a traditional AI sense. The device does perform automated data processing (e.g., auto-scoring of events, calculating indices), which represents an "algorithm only" component. The performance of these algorithmic aspects is implicitly validated through the equivalence to the predicate devices and their prior clearance. For example, the document states: "autoscored 4% desaturation and 4% or 3% apnea-hypopnea events," indicating an algorithm operating on the collected data.
7. The Type of Ground Truth Used
For the predicate devices, the ground truth for diagnosing sleep-disordered breathing and assessing oral appliance efficacy would have been established through methods standard in sleep medicine, likely including:
- Expert Consensus: Interpretation of polysomnography (PSG) data by board-certified sleep physicians.
- Outcomes Data: Demonstrating clinical benefit (e.g., reduction in AHI, improvement in ODI) with the oral appliance therapy guided by the device.
For this specific 510(k) (K191925), the ground truth for demonstrating equivalence rests on the technical performance of the modified components meeting the standards and identical functional outcomes of the previously cleared predicate. For example, performance bench testing was completed to demonstrate the mandibular positioner and oximeter meet the same performance criteria as the predicate.
8. The Sample Size for the Training Set
Not applicable, as this submission did not involve the development or re-training of a new AI model with a distinct training set. The device is an updated version of existing hardware and software, with the core analytical algorithms presumably carried over from the predicate.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #8. For the original development of the algorithms in the predicate device, ground truth would have been established through expert-labeled sleep study data.
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