(118 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 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:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of Apnea and Hypopnea Detection: The autoscoring algorithm for detecting apneas and hypopneas should be accurate. | "The autoscoring algorithm for the detection of apneas and hypopneas was accurate." (This is a qualitative statement of meeting the goal rather than a specific quantitative metric like a percentage, sensitivity, or specificity). |
| Comparability to Cleared Predicates (Sensitivity & Accuracy): The device's apnea and hypopnea detection algorithms should have comparable sensitivity and accuracy to previously FDA cleared ventilatory effort recorder devices (e.g., Embletta MPR Sleep Data Recording System K122516). | "The results of this testing demonstrate that the MATRx plus subject's apnea and hyponea detection algorithms have comparable sensitivity and accuracy with previously FDA cleared ventilatory effort recorder devices such as the Embletta MPR Sleep Data Recording System (K122516)." (Again, a qualitative statement affirming comparability rather than providing specific comparative metrics). |
| Additional Features Performance: The new features (ODI 3% autoscoring, preceding peak baseline, event rounding, reduced erroneous scoring) perform as intended. | "All features that were changed from the predicate devices are covered by additional verification testing to ensure the intended performance and was found to produce adequate results. Performance bench testing was performed to validate the addition of the ODI3% autoscoring method, the preceding peak baseline, event rounding, and the improvements to reduce erroneous scoring." |
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).