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510(k) Data Aggregation
(44 days)
CARDIO COMM SOLUTIONS, INC.
The HeartCheck ECG Pen with GEMS Home is a telemedicine based solution that is intended to enable adult patients to record, store, transfer and display single channel ECG waveforms while involved in everyday activities anywhere. The HeartCheck ECG Pen combined with GEMS Home enables the person to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional such as a physician. GEMS Home use is not intended to substitute for a hospital diagnostic ECG test. The software and hardware are not intended for recording and transmission of user's ECG signal simultaneously. Patients with implanted pacemaker or defibrillator are not recommended to use this device. GEMS Home is a simple software user interface with ECG trace viewing function.
The applicant device HeartCheck ECG Pen is a handheld device, which can record cardiac event data and display the data in a clear and precise waveform. The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our manufacturing partner Beijing Choice Electronic Technologies. The HeartCheck ECG Pen is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and are later shown to physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring, the utilization of HeartCheck ECG Pen has the feature of recording this real time data that is normally difficult to capture. The applicant device has a "data upload" function which is controlled by hardware; it can transmit the data measured by the device to a computer via the USB port. The GEMS Home software is used to store and review the data collected by the HeartCheck ECG Pen Monitor. The GEMS Home software is installed onto the computer from a CD ROM by the user. The GEMS Home software CD ROM is an accessory of the applicant device. The applicant device has low battery voltage indication function. 2 AAA batteries supply the power for the monitor.
The provided document describes the HeartCheck ECG Pen with GEMS Home, a device intended for adult patients to record, store, transfer, and display single-channel ECG waveforms. It also enables patients to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional.
Here's an analysis of the acceptance criteria and the study information as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific acceptance criteria. However, it states that the device complies with certain standards and underwent several performance tests. The "reported device performance" is essentially that the device passed these tests and met the stated standard requirements.
| Acceptance Criterion (Standard/Test) | Reported Device Performance |
|---|---|
| Standards Compliance | |
| IEC60601-1 | Complies with the standard. |
| IEC 60601-1-2 | Complies with the standard. |
| AAMI EC38 | Complies with the standard. |
| Specific Performance Tests | |
| Low Voltage Indication Validation Test | Performed on the applicant device to validate its performance. Results indicate compliance. |
| Shock Test | Performed on the applicant device to validate its performance. Results indicate compliance. |
| Random Vibration Test | Performed on the applicant device to validate its performance. Results indicate compliance. |
| Sinusoidal Vibration Test | Performed on the applicant device to validate its performance. Results indicate compliance. |
| Heart Rate Accuracy Test (Shelf Life) | Performed on the applicant device to validate its performance. Results indicate compliance and the device is equivalent to the predicate device in capability. |
| High, Low Temperature & Humidity Test | Performed on the applicant device to validate its performance. Results indicate compliance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of these tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
The document does not mention the use of experts to establish ground truth for any of the performance tests. The testing appears to be focused on device technical performance against engineering and safety standards, rather than direct clinical interpretation by human experts. The intended use states that ECGs are sent to a "qualified health service professional such as a physician" for review and interpretation, but this refers to the clinical use of the device, not its performance validation in a study for regulatory submission.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method as the performance testing focused on quantitative hardware/software performance against standards, not on human interpretation or medical diagnosis where adjudication would typically be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluation focuses on the device's technical specifications and compliance with safety and performance standards, comparing it to predicate devices based on similar intended use and technological characteristics. There is no mention of comparing human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
The document describes the device as providing ECG waveforms that are then sent to a "qualified health service professional" for review and interpretation. This inherently suggests a human-in-the-loop process. The "GEMS Home is a simple software user interface with ECG trace viewing function," indicating it's a display tool rather than an autonomous diagnostic algorithm. Therefore, a standalone (algorithm only) performance study as it relates to diagnostic interpretation was not done or described. The performance testing section pertains to the device's hardware and software functionality in recording and transmitting data accurately, not its ability to interpret ECGs independently.
7. The Type of Ground Truth Used
For the performance tests described (e.g., Heart Rate Accuracy, Shock, Vibration, Temperature), the "ground truth" would be established by:
- Reference standards/equipment: For heart rate accuracy, this would involve comparing the device's reading to a known, precise heart rate source.
- Engineering specifications and regulatory standards: The device is tested against established limits and methodologies defined by standards like IEC60601-1, IEC 60601-1-2, and AAMI EC38.
There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic accuracy studies, which is not the focus of the performance tests detailed here.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is consistent with the type of device and testing described. The HeartCheck ECG Pen with GEMS Home is a data acquisition and display device, not an AI/ML-based diagnostic algorithm that would require a "training set" in the context of machine learning. The "software" aspect is a user interface for viewing traces, not a learning algorithm.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned or implied for a machine learning algorithm, therefore, this information is not applicable to the provided document.
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(241 days)
CARDIO COMM SOLUTIONS, INC.
The HeartCheck™ Pen Handheld device with GEMS Home software is an over-thecounter device intended to record, store, transfer single channel Heart Rhythm signals and, for users under a physician's care, display Heart Rhythm waveforms. The HeartCheck™ Pen Handheld device along with GEMS Home software is not intended to substitute a hospital diagnostic ECG device. The device is not intended for simultaneously recording and transmitting a user's Heart Rhythm. Users with an implanted pacemaker or a defibrillator are not recommended to use this device. GEMS Home is a simple software user interface for managing Heart Rhythm recordings and associated data.
The applicant device of HeartCheck Pen is a handheld device. which can record cardiac event data. As delivered to the end user. Heart Rhythm recordings are made on the HeartCheck™ Pen Heart Rhythm device and uploaded to GEMS Home, but the Heart Rhythm Waveform itself is not visible to or accessible by the user. GEMS Home allows the user to manage their personal information, their Heart Rhythm recordings and upload their Heart Rhythm recordings for Physician Review. Once the end user is under the guidance of a qualified Health Care Professional (e.g. Physician. Trained Technician. etc.), the Health Care Professional can use the access-controlled "Physician Review" section of the existing CardioComm Solutions Rx Only devices to initiate a process to "unlock" the GEMS Home Software and the HeartCheck™ Pen Heart Rhythm device to allow the end user to see their Heart Rhythm Waveforms in the GEMS Home software and on the device. Access to the "Physician Review" component of the existing CardioComm Solutions Rx Only devices is restricted to Health Care Professionals. The "unlock" feature is not accessible to anyone other than qualified Health Care Professionals and can only be initiated once the user has uploaded their collected HR Data from the GEMS Home.
The Heart Rhythm Monitor is made up of signal input unit, signal amplify unit. CPU. Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our manufacturing partner Beijing Choice Electronic Technologies.
The HeartCheck™ Pen Heart Rhythm device is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and can be later uploaded for review by qualified Health Care Professionals for confirmation of these symptoms.
The applicant device has a "data upload" function which is controlled by hardware; it can transmit the data measured by the device to a computer via the USB port. The "GEMS Home" software is used to store and review the data collected by the HeartCheck Pen Heart Rhythm Monitor. The "GEMS Home" software is installed onto the computer from a CD ROM by the user. The "GEMS Home" software CD ROM is an accessory of the applicant device.
The applicant device has low battery voltage indication function. 2 AAA batteries supply the power for the monitor.
The provided text describes performance testing for the HeartCheck™ Pen Handheld device with GEMS Home software, but it does not explicitly state specific acceptance criteria or report device performance against those criteria in a tabular format. Instead, it lists the standards the device complies with and the types of tests performed.
Therefore, many sections of your requested output cannot be directly extracted from the provided text. I will fill in the available information and explicitly state when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (as stated in document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Electrical Safety | Compliance with IEC60601-1 | Device complies with IEC60601-1 |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Device complies with IEC 60601-1-2 |
| ECG Performance | Compliance with AAMI EC38 standards | Device complies with AAMI EC38 standards |
| Low Voltage Indication | Not explicitly stated | Low Voltage Indication Validation Test was performed. Results not provided. |
| Mechanical Shock | Not explicitly stated | Shock Test was performed. Results not provided. |
| Random Vibration | Not explicitly stated | Random Vibration Test was performed. Results not provided. |
| Sinusoidal Vibration | Not explicitly stated | Sinusoidal Vibration Test was performed. Results not provided. |
| Heart Rate Accuracy | Not explicitly stated | Heart Rate Accuracy Test (Shelf Life) was performed. Results not provided. |
| Temperature & Humidity | Not explicitly stated | High, low temperature & humidity Test were performed. Results not provided. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified in the provided document. The document mentions "qualified Health Care Professionals (e.g. Physician. Trained Technician. etc.)" for review of recorded data, but this is in the context of the device's intended use and not for establishing ground truth in performance testing.
- Qualifications of Experts: Not specified in the provided document for performance testing.
4. Adjudication method for the test set
- Adjudication Method: Not specified in the provided 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
- MRMC Study: Not mentioned in the provided document. The device is a handheld heart rhythm monitor, and the study described focuses on technical performance rather than a comparative effectiveness study involving human readers and AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The performance testing described focuses on the device's technical performance (electrical safety, EMC, heart rate accuracy, mechanical robustness, environmental resistance). It does not explicitly mention "algorithm only" performance. The device records and stores signals for later review by professionals, suggesting a human-in-the-loop component for interpretation of the waveforms in its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified in the provided document. For tests like "Heart Rate Accuracy," it is implied that a reference standard was used, but the nature of that standard is not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/mentioned. The device is a monitor, not an AI/ML algorithm that undergoes a training phase as typically understood in machine learning. Its performance is validated against compliance standards and specific functional tests.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As noted above, this document does not describe an AI/ML algorithm requiring a training set with established ground truth in this context.
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