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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.

Study Details

The provided text describes a clinical study conducted for performance validation.

1. 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."

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

   • Not specified in the provided text.

3. Adjudication Method for the Test Set:

   • Not specified in the provided text.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders.

The Noga System is intended to be used for analysis, display, redisplay (retrieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device.

Physiological data includes: ECG, SpO2, EtCO2 and Impedance respiration.

The Noga Automated Study Scoring and Data Management System (Noga System) is a Web-based computer program (software), intended for use as an aid to the diagnosis of respiratory-related sleep disorders.

The Noga System is designed to process the raw signal data acquired by a third party physiological activity monitoring 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 physiological activity monitoring device include the following:

• ECG
• Impedance respiration
• EtCO2
• SpO2

Scoring Analysis includes:

• Apnea/Hypopnea Index (AHI)
• Sleep Staging (Sleep - Wake stages, and Total Sleep Time)
• Respiratory Events Detection (Apnea and Hypopnea)

Here's a summary of the acceptance criteria and the study details for the Noga Automated Sleep Study Scoring and Data Management System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • The document states that "A clinical study was conducted," but it does not explicitly state the sample size (number of patients or studies) used for the test set.
   • Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number of experts used to establish the ground truth for the test set.
   • Qualifications of experts: The ground truth was established against "gold-standard PSG manual scoring." This implies human experts (sleep technologists or physicians) performed the manual scoring, but their specific qualifications (e.g., years of experience, board certification) are not provided.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not specify an adjudication method. It simply refers to "gold-standard PSG manual scoring."

4. 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:

   • The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The study focused on the standalone performance of the Noga system compared to gold-standard and a predicate device.

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

   • Yes, a standalone performance study was done. The clinical study validated "the accuracy of the Noga System to detect respiratory related sleep disorders against both a gold-standard PSG and the Morpheus predicate device." This assesses the algorithm's performance directly.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The primary ground truth used was expert consensus / manual scoring, specifically "gold-standard PSG manual scoring". It was also compared against the performance of a predicate device (Morpheus).

7. The sample size for the training set:

   • The document does not provide information on the sample size used for the training set. It only mentions that the Noga software program is "based on the Morpheus software program."

8. How the ground truth for the training set was established:

   • The document does not explicitly state how the ground truth for the training set was established. Given that the Noga software is based on Morpheus, it is likely that Morpheus's training data and ground truth establishment methods would be relevant, but this is not detailed for Noga itself.

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The Morpheus ™ 1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

The Morpheus ™ 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This device is to be used under the supervision of a physician.

The Morpheus™ 1, Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

The Morpheus 100 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This document primarily focuses on the FDA 510(k) clearance for the Morpheus™ 1 Automated Sleep Study Scoring and Data Management System, establishing its substantial equivalence to a predicate device. It does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and study description based on the provided text. The document is an FDA letter and a declaration of indications for use, not a clinical study report.

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