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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 < 10 with custom appliance) and "unsuccessful treatment" (ODI ≥ 10) was based on "automated analysis of a full night home sleep test," which implies an objective measurement, potentially overseen or interpreted by these professionals. For the "Identification of Efficacious Target Protrusion," if the initial target wasn't successful (ODI < 10), the oral appliance was advanced and retested, indicating involvement of a clinical expert.
  • Human Factors: Not explicitly stated, but the process involved "Participants and providers were evaluated for comprehension-based tasks."
• Qualifications of Experts:
  • Sleep Health Professional: Reviewed baseline HSAT data. (Specific qualifications like "radiologist with 10 years of experience" are not provided, only the role title).
  • Licensed Dentist: Evaluated for adequate dentition, fitted titration trays, measured protrusion values, conducted intraoral exams, and performed subjective interviews post-study. (Specific qualifications like years of experience are not provided).

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal "adjudication method" (like 2+1 or 3+1 consensus) for establishing the ground truth of the test set results. The primary effectiveness endpoint, successful/unsuccessful treatment with an oral appliance, was defined retrospectively by an "automated analysis of a full night home sleep test" using the ODI < 10 criterion. This suggests an objective, rule-based approach rather than a multi-expert consensus for the final outcome. However, "All baseline data were reviewed by a Sleep Health professional," and the follow-up for target protrusion involved clinical discretion ("adjusted accordingly based on clinical expertise of the dentist"), indicating expert involvement in data interpretation and treatment adjustments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study evaluated the standalone performance of the MATRx plus device in predicting OA therapy success and recommending a target mandibular position. It did not compare human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study assessing the algorithm's performance was conducted. The "Predictive Accuracy" effectiveness endpoint explicitly states: "The MATRx plus predictive accuracy endpoint was assigned if the sensitivity and specificity was found to be statistically significant..." and "The predication was done using a trained binary classifier." This refers to the algorithm's ability to identify responders and recommend a target protrusion on its own, based on the collected physiological data. While human factors and clinical oversight were part of the overall process, the core predictive power evaluated was that of the device's algorithm.

7. Type of Ground Truth Used

The primary ground truth for the effectiveness endpoint ("Successful treatment with an oral appliance") was outcomes data: achieving an Oxygen Desaturation Index (ODI) of less than 10 events per hour with a custom oral appliance, determined by automated analysis of a full night home sleep test.
For the target protrusion accuracy, the ground truth was the clinically determined effective protrusion (the position where ODI < 10 was achieved with the custom OA, potentially after clinician-guided titration).

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. It only describes the pivotal clinical trial (Phase II) which appears to be the test set for evaluating the device's performance. It mentions "The predication was done using a trained binary classifier," implying a training phase occurred, but details about the data used for training are absent from this text.

9. How the Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established, as it does not detail the training process or the data used for it. It only mentions that the prediction was made using a "trained binary classifier," implying ground truth data was used for its training.

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The Oximetry Module can be used with Philips Respironics BiPAP C Series (BiPAP AVAPS and BiPAP S/T) ventilators to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate for adult and pediatric patients. The Oximetry module may be used in a hospital or home care environment.

The Philips Respironics BiPAP C-Series Ventilatory System (BiPAP AVAPS and BiPAP S/T) is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of ages; > 18 kg) patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C-Series Ventilatory Support System may be used in the hospital or home.

The Respironics BiPAP C-Series (BiPAP AVAPS and BiPAP S/T) Ventilatory Support Devices when used with the Respironics Link Module Oximetry Interface Kit provides access to patient therapy information through the two-way transfer of data between patient devices and clinicians through the appropriate software including therapy efficacy and device settings as requested by the attending physician.

The Oximetry Interface Kit consists of the following components:

• Respironics Link Module
• SD Card and Mailer
• Masimo Oximetry Module and Sensor

When connected to the flow generator, the oximetry module records treatment and pulse oximetry data during therapy. The data is stored on a secure digital card. After treatment, the secure digital card containing the data can be removed from the device and sent to the clinician for review.

The Respironics BiPAP C-Series (BIPAP AVAPS and BiPAP S/T) devices, cleared under K092818, when used with the Respironics Oximetry Interface Kit are microprocessor controlled blower based positive pressure systems that interface with an with integrated heated humidifier, like the predicate cleared in K102465.

I am sorry, but the provided text does not contain the specific details about acceptance criteria, device performance tables, sample sizes, expert qualifications, or ground truth establishment relevant to the request. The document describes a 510(k) submission for a medical device (Respironics BiPAP Ventilator Series Oximetry Interface Kit) and focuses on administrative information, intended use, device description, non-clinical testing, and a statement of safety and effectiveness, mostly comparing it to predicate devices.

The "Test Execution Summary" section mentions several tests (Time Meters, Standard Regression Test, Pulse Oximetry User Interface, Pulse Oximetry Logging, Serial Port AutoBaud Detection, User Interface – Monitor Parameters Submenu) and states that "All tests have passed and requirements referenced in these tests have been verified," and "All tests were verified to meet the required acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the reported device performance in a table format. It also does not delve into the methodology of studies with details like sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or how ground truth was established for training sets, which are usually part of more comprehensive study reports rather than a 510(k) summary.

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