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The MATRx plus is indicated for use by a lay person in a 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 the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for oral appliance therapy 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.

The device is intended to be used on adult patients, upon referral from their healthcare provider.

The device is not to be used as an apnea monitor or in a life supporting or life sustaining situation and must not be used in the vicinity of an MRI device.

The MATRx plus device underwent non-clinical and clinical testing to demonstrate its substantial equivalence to its predicate device (K191925).

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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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.

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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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 an HCP.

The MATRx plus device is a ventilatory effort recorder. 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 oximeter, and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and positioned 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. The Tablet 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 provided text describes a 510(k) premarket notification for the MATRx Plus device, a ventilatory effort recorder. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (K163665 MATRx Plus) and includes modifications to the scoring algorithms.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided information:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in a table format with specific thresholds. Instead, it demonstrates performance through clinical validation and by showing the new features (3% oxygen desaturation index, 3% and 4% apnea-hypopnea index, preceding peak baseline option, and improved event scoring algorithms) produce "adequate results" and that the device has "comparable sensitivity and accuracy" to a cleared predicate.

However, we can infer the implicit acceptance criteria from the clinical validation study's goal: to demonstrate that the autoscoring algorithm for the detection of apneas and hypopneas was accurate, and that its sensitivity and accuracy are comparable to previously FDA cleared devices.

Inferred Acceptance Criteria & Reported Performance:

Note: The document provides very high-level summaries of the testing and the results. Specific quantitative metrics (e.g., exact sensitivity/specificity values, or statistical results demonstrating "comparable" performance) are not detailed within this 510(k) summary.

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 27 individuals
   • Data Provenance: Subjects had "confirmed or suspected sleep apnea." The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is implied to be prospective clinical validation.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The document states that the performance was compared to "the gold standard, polysomnography." It does not specify the number of experts (e.g., sleep specialists, polysomnography technologists) involved in interpreting the polysomnography or establishing the ground truth, nor their specific qualifications. It is generally understood that polysomnography interpretation is performed by qualified sleep physicians or technologists.

3. Adjudication Method for the Test Set:

   • The document does not describe any specific adjudication method for the ground truth of the test set beyond stating that polysomnography was the "gold standard." There is no mention of 2+1, 3+1, or other multi-reader adjudication processes.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No. The study described is a comparison of the device's autoscoring algorithm against a polysomnography gold standard, not a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no effect size reported for human readers' improvement with AI vs. without AI.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

   • Yes. The clinical validation directly assesses the performance of the "autoscoring algorithm for the detection of apneas and hypopneas" by comparing its output to polysomnography. This is a standalone assessment of the algorithm's performance.

6. The Type of Ground Truth Used:

   • Expert Consensus / Physiological Gold Standard: The ground truth used was polysomnography (PSG), which is considered the clinical gold standard for diagnosing sleep disordered breathing. While PSG involves expert interpretation, the document frames PSG itself as the "gold standard" rather than raw pathological findings or purely outcome data.

7. The Sample Size for the Training Set:

   • The document does not provide any information about the sample size (or any details) of the training set used for the algorithm's development. The focus of this 510(k) summary is on the validation of the modified algorithm.

8. How the Ground Truth for the Training Set Was Established:

   • This information is not provided in the document. As mentioned, the document focuses on the validation of the device's modified algorithms.

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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

Bench Performance Testing

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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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.

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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