Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia. The device continuously monitors and records the data, automatically records alarm 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.

TeleSentry is a battery powered ambulatory ECG monitor which analyzes an electrocardiographic signal. The TeleSentry device classifies all detected heart beats and recognizes specific rhythm abnormalities. All detected results, including annotations for every detected heart beat and the ECG signals are securely transmitted via a cellular telephony network to a remote server. The server is accessible by a monitoring center for review and evaluation by trained qualified medical staff. The data transmission is automatically triggered when abnormalities are detected. The triggering criteria are based on physician's recommended predetermined settings and adjustable thresholds programmed for brady, tachy, pause and afib events. The data will also be transmitted when manually triggered by the patient; or periodically if programmed for regular transmission. The TeleSentry device is equipped with sufficient memory and processing capacity to record the signal received from the sensor, even while in parallel, allowing interrogation of the device data or adjustment of triggering thresholds. The TeleSentry device records and stores the entire ECG full disclosure for up to 30 days on its internal storage card. When cellular service is not available, the monitoring center is immediately notified and data can be transmitted via land-line telephone using a USB connection or a Bluetooth connection, or via broadband internet connection.

The provided text describes the ScottCare TeleSentry Wireless Ambulatory ECG Arrhythmia Monitor and its 510(k) submission (K092947). It references performance testing against established standards but does not detail a specific study with acceptance criteria and reported device performance in the format requested.

Here's a breakdown of the available information based on your request, highlighting what is not explicitly stated in the document:

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

The document states: "The TeleSentry device was tested and meets the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm."
It lists the following standards:

• IEC 60601-1:1999 "Medical Electrical Equipment Part 1: General . Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995"
• IEC 60601-1-2:2001/AI:2004 "Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests" Class B
• AAM1/ANSI EC38:2007 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
• AAMI / ANSI EC57:1998/(R)2003 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms

However, the document does NOT provide a table detailing specific quantitative acceptance criteria (e.g., sensitivity, specificity for arrhythmia detection) from these standards and the TeleSentry's reported performance against them. It only states that the device "meets the requirements."

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The device description mentions data review by "trained qualified medical staff" in a monitoring center, but this refers to the operational use of the device, not the ground truth establishment for a validation study.

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

This information is not provided in the document.

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 document. The filing is for a standalone arrhythmia monitor with an algorithm that triggers events for review by medical staff, not a system designed to directly improve human reader performance in a comparative study format.

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

Yes, the device description implies a standalone algorithm performance as it "analyzes an electrocardiographic signal," "classifies all detected heart beats and recognizes specific rhythm abnormalities," and "automatically records alarm events triggered by an arrhythmia detection algorithm." The phrase "automatically records alarm events triggered by an arrhythmia detection algorithm" suggests standalone algorithmic detection. The subsequent review by medical staff is part of the clinical workflow, but the initial detection is algorithmic. The performance testing against AAMI / ANSI EC57:1998/(R)2003 (Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms) would involve evaluating the standalone algorithmic performance.

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

This information is not explicitly stated in the document. For cardiac rhythm algorithms, ground truth is typically established by expert cardiologists reviewing the ECG tracings and marking events. The standards referenced (especially AAMI EC57) define methods for establishing such ground truth, but the specific method used here for the TeleSentry's testing is not detailed.

8. The sample size for the training set

This information is not provided in the document. The document describes performance testing, not details about the development or training of the arrhythmia detection algorithm.

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

This information is not provided in the document, as details about the training set are absent.

Ask a specific question about this device

The intended use of the Chroma Holter Recorder RZ153C is to perform ambulatory ECG on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording.

The basic operation of the Chroma Holter Recorder RZ153C is to collect and store multiple channels of ECG data. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.

The provided text describes a 510(k) premarket notification for the ScottCare Chroma Holter Recorder RZ153C, comparing it to a predicate device, the DXP1000 Holter Recorder. However, the document does not contain specific acceptance criteria, quantitative performance metrics, or detailed study methodology in the way that would typically be presented for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through feature comparison and qualitative outcome of testing.

Here's an analysis based on the information provided, addressing your specific questions to the best of my ability with the given text:

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

The document does not explicitly state quantitative acceptance criteria or performance metrics for the Chroma Holter Recorder RZ153C's functionality. The evaluation is based on demonstrating "substantial equivalence" to the DXP1000 Holter Recorder via comparison of features and functional outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "The Chroma Holter recorder RZ153C was tested alongside the DXP1000 Holter recorder in a number of situations, including simulated normal ECG signals, simulated paced ECG signals, and on-person ECG signals in laboratory tests."

• Sample Size: Not specified. The phrase "a number of situations" implies multiple tests but no specific count of patients, simulated signals, or recording durations.
• Data Provenance: Not specified. It mentions "laboratory tests" and "on-person ECG signals," implying some form of prospective data collection during testing, but details on location or patient demographics are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a Holter recorder, which collects and stores ECG data; it does not perform diagnosis or interpretation itself (as stated: "This recorder is not capable of any diagnosis nor can it provide any interpretation of the data."). The "Holter for Windows software" is mentioned as reading and providing the ability to review, edit, and print the collected data. Therefore, the concept of "ground truth established by experts" for the device's output (raw ECG data) is not applicable here in the same way it would be for an AI/CADe diagnostic device. The ground truth for its performance would be the accurate capture and storage of ECG signals, which was compared against a predicate device. No details on expert involvement for ground truth establishment for the test set are provided.

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

Not applicable, as this is a device that records physiological signals, not an interpretive AI system requiring adjudication of diagnostic outputs. The evaluation focused on the similarity of recorded data between the new device and the predicate.

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 such study was conducted or reported. This device is a data acquisition tool, not an AI/CADe system designed to improve human reading performance.

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

The device is a standalone Holter recorder. Its performance was assessed in "laboratory tests" by comparing its recorded output with that of a predicate device against "simulated normal ECG signals, simulated paced ECG signals, and on-person ECG signals." The assessment was qualitative ("produced results very similar").

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

The "ground truth" implicitly used for the recorder's function would be the known characteristics of the "simulated normal ECG signals" and "simulated paced ECG signals," and the actual cardiac activity of the individuals providing "on-person ECG signals." The assessment compared the device's recorded output against the known inputs or the output of a trusted predicate device, rather than against an expert-adjudicated diagnostic label.

8. The sample size for the training set

This device does not use an "AI algorithm" or machine learning in the sense that would require a dedicated training set. It is a hardware device for recording physiological signals. Therefore, the concept of a "training set" is not applicable.

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

Not applicable, as there is no training set for an AI algorithm.

Ask a specific question about this device

The intended use of the ScottCare Genesis ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

The "Genesis" is a non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therapy. The microprocessor's primary function is to serve as an R-wave detector, calculate the R-wave rate (heart rate), and deliver triggering signals to actuate valves that allow the cuffs to be filled during the diastolic period and then emptied prior to systole. The secondary function of the microprocessor is to output, through a serial port, information necessary for displaying patient treatment data on a video monitor. This data allows a trained operator to finetune the inflation/deflation signals to optimize a patient's diastolic augmentation. The cuffs are snugly wrapped around the patient's calves, thighs, and buttocks to allow compression of vascular beds in these body areas. To prevent skin irritation the patient is typically dressed in tight fitting, stretchable treatment pants prior to being fitted with the cuffs. As diastole begins, the cuffs inflate sequentially proceeding from the calves, to the thighs, to the buttocks, with the inflation sequence taking a total of approximately 200ms. The inflation sequence generates and drives an arterial counter pulsation wave creating an increase in coronary perfusion pressure and coronary blood flow. The compression sequence also increases venous return, which increases stroke volume and cardiac output. At the end of diastole, and just before the next QRS complex, the cuffs are evacuated simultaneously over a period of approximately 120ms. The course of treatment is typically 35 1-hour treatments administered 5 days a week. The device automatically stops compression of the cuffs and releases all pressure in the cuffs upon completion of the pre-set treatment timer. The system consists of two major assemblies: 1) the patient bed that houses the electronic pneumatic controls / valves, compressor / vacuum pump and associated power supplies and 2) the operator's console that consists of an all-in-one computer/monitor, computer peripherals (keyboard and pointing device) and a control panel.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the "ScottCare Genesis ECP Device," primarily focused on demonstrating substantial equivalence to a predicate device.

It lists:

• Device Description: How the ECP device works.
• Indications for Use: The medical conditions the device is intended to treat.
• Substantial Equivalence Comparison: A table comparing features of the new "Genesis" model with the predicate device "NCP-1 Counter Pulsation Device."
• Conclusion: States that testing (without details on specific acceptance criteria or results) demonstrated the device functioned as designed and complied with IEC60601 safety and EMC requirements. It concludes substantial equivalence to the predicate device.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device