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The TeleRehab® Aermos Cardiopulmonary Rehabilitation System is intended to acquire and condition the ECG signal from a patient so that it can be transmitted wirelessly from a radiofrequency transmitter to a workstation in a hospital or a clinical setting where the data is displayed and analyzed. This device also measures heart rate and provides visual and audible alarms if the patient's heart rate goes out of a prescribed range. This device is for use with ambulatory adult patients who need monitoring while undergoing cardiovascular and/or pulmonary rehabilitation. The physiological data from monitoring and other patient information (such as patient demographics, exercise protocol and medical information) is stored in a database for tracking and reporting of the patients' progress through rehabilitation.

The TeleRehab® Aermos Cardiopulmonary Rehabilitation System ("Aermos") provides the ECG monitoring functionality required for performing rehabilitation of cardiovascular and/or pulmonary patients. Patients' ECG may be monitored using the Aermos system during exercise under clinical supervision. During monitoring, Aermos provides both visual and audible alarms if the patient's heart rate goes out of a prescribed range. The heart rate alarm indication is one of multiple inputs a clinician may use to modify and adjust rehabilitation activities such as decreasing the patient's level of physical exertion or halting the exercise entirely.

Aermos also provides the ability to plan a patient's rehabilitation program and document the patient's progress through the creation of various types of reports. The report types supported in Aermos include individual treatment plan reports, daily exercise session reports and various patient information reports. Additionally, the Aermos system provides the ability to transfer various report types to the hospital Electronic Medical Records system.

The main components of Aermos are Argus ECG transmitters, the Aermos Workstation and associated networking equipment.

This FDA 510(k) clearance letter pertains to the TeleRehab Aermos Cardiopulmonary Rehabilitation System, which is a device for monitoring ECG signals and heart rate during patient rehabilitation. The provided documentation (the 510(k) Summary) details non-clinical bench testing for performance and safety but explicitly states that clinical testing was not applicable.

Therefore, based on the provided document, the following information regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning an AI/algorithm-driven component with clinical performance metrics, cannot be fully extracted or is explicitly stated as not performed:

Here's an analysis of the provided information relative to your request:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

Since no clinical study was performed, the "reported device performance" would pertain to the results of non-clinical bench testing against established performance standards. The document does not provide specific quantitative acceptance criteria or reported numerical performance results for the device. Instead, it states that the device's specifications were "verified through internal verification testing" and its usability "evaluated through internal validation testing," and that it complies with various international standards.

Study Details (Based on the provided 510(k) Summary)

1. A table of acceptance criteria and the reported device performance:

   • See the table above. Specific quantitative acceptance criteria beyond "compliance with standard" are not provided in this regulatory summary.

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

   • The document explicitly states "Clinical Testing: Not applicable."
   • For the non-clinical bench testing, specific sample sizes (e.g., number of devices tested, number of test cases) are not detailed in this 510(k) summary.
   • Data provenance for non-clinical testing would typically be internal laboratory data generated during device development and verification. There is no mention of geographical origin or retrospective/prospective nature as this was not clinical data.

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

   • Not applicable, as no clinical study with human interpretation/ground truth was performed. The "ground truth" for bench testing would be defined by validated test equipment and reference standards.

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

   • Not applicable, as there was no study involving human readers or interpretation requiring adjudication.

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:

   • No MRMC study was done, as clinical testing was "Not applicable." The device is a physiological signal monitor, not an AI-assisted diagnostic tool that interprets images or signals requiring human reader comparison.

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

   • The core functionality of the device (ECG acquisition, heart rate measurement, alarms) is algorithmic. The performance of these algorithms would have been assessed during the non-clinical bench testing, which is essentially "standalone algorithm" testing against known inputs and expected outputs. Specific quantitative results (e.g., algorithm accuracy for heart rate) are not provided in this summary beyond "compliance with IEC 60601-2-27" and "ANSI/AAMI EC57: 2012, Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measure Algorithms."

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

   • For non-clinical bench testing, the "ground truth" is typically established by:
     • Reference standards and calibrated test equipment: For electrical performance, signal acquisition accuracy, frequency response, etc.
     • Simulated physiological signals: For testing heart rate calculation and alarm thresholds.
     • Design specifications and established engineering principles: For software functionality and cybersecurity.

8. The sample size for the training set:

   • Not applicable. The device is a monitoring system and not primarily driven by a deep learning or machine learning algorithm that requires a "training set" in the sense of a large dataset for model development. The algorithms for heart rate calculation, etc., are likely traditional signal processing algorithms.

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

   • Not applicable, as there was no training set for a machine learning model.

Summary of Device Nature and Regulatory Pathway:

The TeleRehab Aermos Cardiopulmonary Rehabilitation System is a Class II device (Product Codes DRG, DRT) which functions as a physiological signal transmitter and receiver. It monitors ECG and heart rate and provides alarms. Its 510(k) clearance relied on demonstrating substantial equivalence to predicate devices primarily through non-clinical bench testing against recognized industry standards (e.g., IEC 60601 series, ANSI/AAMI, ISO standards) and adherence to FDA guidance documents (e.g., for software, cybersecurity, reprocessing). The explicit statement "Clinical Testing: Not applicable" indicates that the nature of the device and its intended use, combined with the comprehensive non-clinical data, satisfied the FDA's requirements for demonstrating safety and effectiveness without the need for a human-subject clinical study. This is common for devices that are evolutionary improvements on existing technologies with well-understood performance parameters.

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The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.

The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer the Electrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi. TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended for pediatric use. Examples of applications are:

• Cardiology
• Pulmonary Care
• Home Care
• General Practitioners

The basic operation of the TeleSense platform is to collect and store multiple channels of ECG data. The TeleSense platform was developed to be used as basic platform for 4 different variants on the product, hereafter called "modes". The electronic platform of the different versions is identical but the different modes have some features added or removed from the electronic platform. The differences are related to features. All versions have the same intended use, intended users and intended environment. The different versions are described below.

1. Basic Mode (Remote cardiac monitor)
   TeleSense's Basic Mode is the basic version of the product. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer the Electrocardiogram (ECG) in mobile patients, as well as cardiac event data. The device only uses non-invasive sensors. The available integrated data transfer methods are USB and Wi-Fi.

2. Event Mode
   TeleSense's Event Mode operates as a traditional event recorder. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer manually indicated or automatically detected cardiac events in mobile patients. The device only uses non-invasive sensors. The available integrated data transfer methods are Wi-Fi and USB.

3. Holter Mode
   TeleSense's Holter Mode operates as a traditional Holter recorder. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer the electrocardiogram (ECG) in mobile patients. The device only uses non-invasive sensors. The available integrated data transfer methods are Wi-Fi and USB. In this version, there is no automatic cardiac event detection.

The provided text describes the 510(k) Summary for the TeleSense device and its comparison to a predicate device, the ScottCare TeleSentry. Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than explicitly detailing a study to prove acceptance criteria for novel performance claims. The "testing results summary" primarily discusses adherence to established safety, electrical, and performance standards and internal tests with simulated signals. It does not provide detailed performance metrics for arrhythmia detection or a traditional clinical study with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity for arrhythmia detection). Instead, it compares specific features and technical specifications to a predicate device, arguing that differences do not adversely impact safety and effectiveness. The "Testing Results Summary" states: "The TeleSense meets the safety, mechanical, electrical, and performance requirements requirements of IEC 60601-1, the emissions requirements of IEC 60601-1-2:2007, and the safety, electrical, and performance requirements of IEC 60601-2-47 Part2."

The key performance statement related to the device's diagnostic function is: "In all tests, the TeleSense produced consistent and acceptable results." This refers to internal tests conducted with simulated ECG signals.

Here's an adaptation based on the provided technical specifications and the comparison with the predicate:

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention human patient data for the test set. The performance testing was conducted using "simulated normal ECG signals and simulated paced ECG signal tests." Therefore, there is no specific "sample size" of real-world patient data or data provenance (country of origin, retrospective/prospective) for a clinical test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Since the testing involved simulated ECG signals, no human experts were used to establish ground truth for this performance "test set." The ground truth was inherent in the simulated signals themselves (e.g., a simulated tachycardia signal would be known ground truth as tachycardia).

4. Adjudication Method for the Test Set

Given that the test set consisted of simulated ECG signals and the ground truth was inherent to these signals, an adjudication method for human review was not applicable or mentioned.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or appears not to have been done for the TeleSense device. The submission focuses on the performance of the device itself relative to technical standards and a predicate, not on how it impacts human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Yes, a form of standalone performance assessment was conducted for the arrhythmia detection algorithm. The "Internal tests" section states: "Data recorded was loaded and analyzed in the HolterCare (K042463) and EventCare (K061780) software. In all tests, the TeleSense produced consistent and acceptable results." This indicates that the device's automatic detection capability with simulated signals was tested without direct human intervention in the detection process itself (though humans would typically review the output).

7. The Type of Ground Truth Used

The ground truth used for the performance testing was based on simulated normal ECG signals and simulated paced ECG signals. This means the "truth" of the arrhythmia or normal rhythm was pre-defined by the simulation parameters.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This type of detail is usually associated with machine learning models that require training. The TeleSense device's arrhythmia detection algorithm appears to be based on established algorithms for which specific training data may not have been detailed in this regulatory filing, or it may use more traditional signal processing methods.

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

Since a training set is not mentioned, the method for establishing its ground truth is not provided in the document.

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