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The MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for:

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
2. Patients with dizziness or lightheadedness.
3. Patients with palpitations.
4. Patients with syncope of unknown etiology.
5. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.
6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.
7. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.
8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias.
9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.

The MoMeTM Continuous ECG Monitor and Arrhythmia Detector System (abbreviated to MoMe System in this section) is a remote physiologic monitoring system that detects non-life threatening arrhythmias. The MoMeTM System incorporates a front end device worn by the patient that collects and streams ECG, heart rate and motion (activity) to a dedicated smartphone that continuously transmits the data to remote server. The system then uses proprietary algorithms to continually analyze data and provide reports of detected events. These reports can be accessed anytime, anywhere by a physician using a standard browser or a MoMe iPad App.

The provided text includes a 510(k) Summary for the MoMe™ Continuous ECG Monitor and Arrhythmia Detector System, which details its performance data and the studies conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003) for the acceptance criteria, and states that the device was tested using "standard industry practices and in accordance" with this guidance. However, the specific acceptance criteria (e.g., minimum sensitivity, specificity for certain arrhythmia types) and corresponding reported device performance values are not explicitly detailed in the provided text. The document broadly states: "The MoMe Arrhythmia detection algorithm has been tested using standard industry practices and in accordance with the FDA Guidance 'Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm', released October 2003. The Software Verification and Validation reports, MoMe System Verification and Validation report, Algorithm validation report, Transceiver Verification and Validation report, Usability test reports all demonstrate that the MoMe System meets its intended use and design input requirements."

Without the specific performance targets from the FDA Guidance and the numeric results from the MoMe system's validation reports, a detailed table cannot be created.

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

The document mentions "Algorithm validation report" but does not specify the sample size of the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided in the given text.

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

This information is not provided in the given text.

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:

This information is not provided in the given text. The study mentioned is a "standalone" algorithm validation, not a comparative effectiveness study involving human readers with and without AI assistance.

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

Yes, a standalone algorithm validation was done. The document states: "The MoMe Arrhythmia detection algorithm has been tested..." and refers to an "Algorithm validation report." This implies testing the algorithm's performance independent of human intervention.

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

The document does not explicitly state the type of ground truth used for the algorithm validation. For arrhythmia detection algorithms, ground truth is typically established by expert cardiologists reviewing the ECG tracings.

8. The sample size for the training set:

The document does not specify the sample size for the training set.

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

The document does not specify how the ground truth for the training set was established.

Summary of available information regarding the study:

• Study Type: Algorithm validation, software verification and validation, system verification and validation, transceiver verification and validation, usability testing.
• Standards Followed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, ANSI/AAMI/ISO EC 57:1998/R(2008), ANSI/AAMI EC53:1995/(R)2008, ISO 10993 (various parts for biological evaluation).
• Compliance: The MoMe System complies with applicable clauses of IEC 60601 and was tested in accordance with the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003).

Missing Information (not found in the provided text):

• Specific quantitative acceptance criteria for arrhythmia detection (e.g., sensitivity, specificity, accuracy for different arrhythmia types).
• Specific quantitative reported performance metrics of the MoMe system against these criteria.
• Sample size of the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for ground truth.
• Details of any MRMC comparative effectiveness study or human reader improvement data.
• Type of ground truth explicitly defined (though likely expert review for ECGs).
• Sample size of the training set.
• Method for establishing ground truth for the training set.

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The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for user adjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.

The Respironics Esprit Ventilator is unchanged from K072450. The only change is to include the Respironics Performax Youth SE mask as an option for use by its pediatric users. This mask is the same mask design as is used by the small size of the cleared Respironics Performax SE Total Face Mask (K072588). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Performax Youth SE mask was designed to meet the 90" percentile for pediatrics age 7 and older and > 40 lbs.

The provided text describes a Special 510(k) submission for the Esprit Ventilator, primarily focusing on adding the Respironics Performax Youth SE mask as an option. As such, the study described is a compatibility test rather than a typical clinical performance study for an AI-powered device.

Here's an analysis based on the provided information, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "mask compatibility testing was performed. This testing included pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria." However, the specific quantitative acceptance criteria or detailed numerical performance results are not provided in this document excerpt.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document indicates "mask compatibility testing was performed" but does not specify the sample size (e.g., number of test sessions, number of masks tested, duration of tests).
• Data Provenance: The testing was "performed" by Respironics, Inc. ("This testing is provided in Tab 8 of this submission"). This implies the data is prospective and generated specifically for this submission, likely within a controlled lab or testing environment. The country of origin of the data is not explicitly stated beyond Respironics being based in the US (Monroeville, Pennsylvania).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable in this context. The study is a compatibility test for a medical device (ventilator and mask), not an AI diagnostic tool requiring expert interpretation to establish ground truth for a test set. The "ground truth" here would be the established functional specifications and performance characteristics of the ventilator and mask system, evaluated against engineering and physiological standards.

4. Adjudication Method for the Test Set

This information is not applicable. Since it's a compatibility test, not an expert-based diagnostic study, there's no need for adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC study was not done. This submission is for a ventilator and mask, not an AI system where human readers would interpret results.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, this is not an AI algorithm. The device, the Esprit Ventilator, is a "microprocessor controlled, electrically powered, mechanical ventilator." The "Auto-Trak option" automatically adjusts parameters, which involves an algorithm, but the study described is about the physical compatibility of a new mask with the existing ventilator, not a performance study of the Auto-Trak algorithm itself.

7. The Type of Ground Truth Used

The ground truth used for this compatibility testing would be the engineering specifications, recognized standards, and physiological performance requirements for a ventilator and its compatible components (like a mask). The verification would be against these predefined technical and performance standards, not against "expert consensus, pathology, or outcomes data" in the typical sense of diagnostic AI studies. The statement "All tests were verified to meet the required acceptance criteria" implies testing against these pre-established standards.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI model requiring a training set.

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

This information is not applicable. This is not an AI model requiring a training set with established ground truth.

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