(113 days)
The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Chevne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB). The Morpheus Ox System is intended to be used for analysis, display, redisplay (retrieve), reports generation and networking of physiological data received from an oximeter device. It does not perform automatic classification of respiratory events as central or obstructive. This system is to be used under the supervision of a physician.
Morpheus Ox displays heart rate, saturation and photoplethysmograph signals, acquired from an oximeter device. Morpheus Ox may also display signals including: EtCO2, Respiratory impedance, Plethysmograph Derived Respiratory (PDR) calculated signal, Activity, ECG, EEG, P flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP.
The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Cheyne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB).
The Morpheus Ox System is designed to process the raw signal data acquired by an oximeter device in standard medical download format, analyze them, obtain the study's analysis results, generate summary reports, and display the signals' data and reports on a personal computer, using a standard Internet Explorer Browser.
Signals from the oximeter device include the following:
- o Saturation
- o Photoplethysmograph signal
Scoring analysis and display includes:
- O Cheyne-Stokes Respiration (CSR)
- 0 Apnea/Hypopnea Index (AHI)
- o Display of acquired signals such as EtCO2, Respiratory impedance, Photoplethysmograph Derived Respiratory (PDR) calculated signal, ECG, EEG, P flow, T flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP, and Heart rate.
Here's an analysis of the acceptance criteria and study details for the Morpheus Ox Automated Sleep Study Scoring and Data Management System, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity values) that the device must meet. Instead, the "Performance Testing" section broadly states that the study was conducted "to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device."
Therefore, I will present the reported device performance as described in the "Substantial Equivalence" section, where it highlights its capabilities in relation to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Aid in diagnosing sleep-related breathing disorders | The Morpheus Ox System is intended for use as an aid in diagnosing sleep-related breathing disorders, similar to cleared predicate devices. |
| Aid in detection of Cheyne-Stokes Respiration (CSR) | The Morpheus Ox System is indicated to aid in the detection of Cheyne-Stokes Respiration (CSR). This is noted as being similar to ApneaLink and SOMNOscreen devices, which also provide CSR information. |
| Estimation of Apnea Hypopnea Index (AHI) | The Morpheus Ox System is indicated to estimate Apnea Hypopnea Index (AHI). This is noted as being similar to SOMNOscreen, Noga System, and ARES devices, which also calculate AHI. |
| Processing and analysis of raw signal data from an oximeter | Like the Noga System, the Morpheus Ox System processes raw signal data from an oximeter device, analyzes signals, obtains study results, generates reports, and displays data on a PC using Internet Explorer. This demonstrates its capability in handling the defined data processing pipeline. |
| Display of additional physiological signals from an oximeter | The Morpheus Ox System is indicated to display heart rate, saturation, and photoplethysmograph signals, as well as other signals like EtCO2, Respiratory impedance, PDR, Activity, ECG, EEG, P flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, and IPAP, consistent with information provided by cleared predicates. |
| Functionality as a software-only program | The device functions as a software-only program used in conjunction with a cleared pulse oximeter, and its core software components and architecture are substantially equivalent to the Noga System. |
| Used in a Cardiac patient population suspected of SDB | The system's specific application to a cardiac patient population suspected of Sleep Disordered Breathing is an intended use, which the "Performance Testing" aimed to validate. The text does not provide specific performance metrics for this population but states the clinical study validated accuracy against gold-standard PSG and predicate. |
Study Details
The provided text describes a clinical study conducted for performance validation.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It only mentions "a clinical study was conducted."
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not specified in the provided text.
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Adjudication Method for the Test Set:
- Not specified in the provided text.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study is not explicitly mentioned. The study is described as validating the accuracy of the device "against both a gold-standard PSG and predicate device," implying a standalone or comparative study of the device, not an assessment of human readers with vs. without AI assistance.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment of the algorithm appears to have been conducted. The text states: "...a clinical study was conducted to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device." This refers to evaluating the Morpheus Ox System (the algorithm/software) directly.
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The Type of Ground Truth Used:
- The primary ground truth used was "a gold-standard PSG" (Polysomnography). The text states: "...a clinical study was conducted to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device." Polysomnography is generally considered the gold standard for diagnosing sleep disorders.
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Sample Size for the Training Set:
- Not specified in the provided text. The text mentions "The Morpheus Ox software program is based on the Noga software program with the changes required to support its intended use and indications for use from the analysis of a different set of signals." This might imply that some underlying training or development was based on data used for the Noga system, but no specific training set size for Morpheus Ox is given.
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How the Ground Truth for the Training Set was Established:
- Not specified in the provided text. Given that Morpheus Ox is based on the Noga system, the ground truth for the Noga system's training would likely have involved expert-scored PSG recordings, but this is not explicitly stated for Morpheus Ox's development.
§ 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).