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510(k) Data Aggregation
(241 days)
HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
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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