(371 days)
The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals.
Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology.
The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving. and printing by healthcare professionals.
CloudEKG can be used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings.
All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.
CloudEKG is a compact and mobile digital electrocardiograph system. When in connection wirelessly with a receiving unit, the device can be worn on a patient's body and serves as a stand alone EKG system for the following purposes:
- . Acquiring EKG signals
- Displaying, processing and storing EKG signals on the receiving unit with the . included POLY-SPECTRUM.NET software
- . Cardiac monitoring and medical diagnosis support for qualified health care providers
The CloudEKG device is not intended for monitoring critical patients or for intra-cardiac use but can be used in outpatient clinical or doctor practice areas.
The device can also be operated by a properly trained patient for home monitoring purposes. The acquired EKG signals are transferred to an external receiving unit via a Bluetooth interface. The signals can be displayed, saved, read, printed and processed by a trained health care provider and transmitted remotely for further use.
The delivery set includes an electronic unit, a patient cable, 2 AA batteries, a Bluetooth adapter, software, and a user manual.
Depending on the chosen number of leads/standards for recording electrocardiographic signals, recordings can be made from:
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- Four (4) standard leads (Einthoven and Goldberger)
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- Six (6) standard leads (Wilson setup)
Sensors, button and tab electrodes can be connected to ColudEKG via electrode clips on the ECG cables. With the integrated data transmission technology, EKG data can be transmitted online to a nearby PC or handheld device unit for evaluation.
The device's principle of operation is based on the recording and transmission of electrocardiogram (EKG) signals to a PC or handheld device for the purpose of cardiac monitoring and diagnosis. The functional scheme of the device is represented in figure 5-1.
The ECG signals collected from the patient are transferred to 8 amplifier channels via the electrodes and cables. The amplified signals are then delivered to multi-channel analog-todigital converter (ADC).
The ADC processes the received information and transfers it to PC or handheld device via Bluetooth radio interface. The signals are processed with the POLY-SECTRUM.NET software, displayed and presented in different modes. The data can be stored, or processed to generate exam reports, or printed for qualified health care providers to interpret the result.
The required power supply for all electronic components of recording is provided by 2 AA alkaline batteries or rechargeable batteries.
The provided 510(k) summary for the TeleEMG, LLC CloudEKG details non-clinical performance testing but does not include any clinical trial data or a study providing acceptance criteria and performance against those criteria. The document explicitly states: "No clinical testing was conducted to support this submission."
Therefore, I cannot provide the requested information regarding acceptance criteria derived from clinical studies, human reader improvement with AI, or standalone algorithm performance, as these are not present in the provided text.
However, I can extract information related to the non-clinical performance testing and the product's specifications as a comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical acceptance criteria or direct performance metrics against such criteria are reported in a comparative study for the CloudEKG, this table summarizes the technical specifications compared to the predicate device, which implicitly serve as performance benchmarks for substantial equivalence. The "Acceptance Criteria" column reflects the predicate device's performance, as the CloudEKG is deemed substantially equivalent based on meeting similar technical specifications.
| Parameter | Predicate Device (Corscience BT3/6, BT12) "Acceptance Criteria" | CloudEKG Reported Performance |
|---|---|---|
| Intended Use | Cardiac monitoring and diagnosis by medically trained persons. Not for critical patients or intracardiac use. Valid only with other clinical findings. Infants 94 dB | 100 dB |
| Pacemaker detection | Yes | Yes |
| Current consumption (Operation) | 148 mA (BT12) | Not more than 140 mA |
| Current consumption (Stand-by) | 37 mA (BT12) | Not more than 40 mA |
| Battery type | 2 × 1.5V alkaline or 2 × 1.2V rechargeable | 2 Batteries of AA type |
| Input impedance | 20 MΩ | ≥ 20 MΩ |
| DC offset correction | ± 190 mA | ± (300 ± 30) mV |
| ECG storage capacity | 5 min/12 channel when transmission is interrupted | No |
| Temperature range (Operation) | 0-50°C | 10-35°C |
| Temperature range (Storage) | -20-70°C | 5-40°C |
| Display | LCD | No |
| Weight | 260 g incl. batteries and cable; 154 g without batteries | Electronic unit: 200 g incl. batteries |
| Electronic unit Dimension | 61 × 106 × 23 mm | 140 × 70 × 24 mm |
| A to D sampling rate | 500 samples/sec | User-defined, 250, 500 and 1000 Hz |
| Data transmission | Wireless (Bluetooth) | Bluetooth radio channel |
| Degree of protection against water | IPX3 | IPX0 |
| Classification | BF | BF |
| Defibrillation protection | Patient cable includes protection circuit. | Electronic unit conforms to IEC 60601-1. Patient cable includes defibrillation protection circuit. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission explicitly states, "No clinical testing was conducted to support this submission." Performance evaluation was limited to hardware and software tests and validations against industry standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical testing, and therefore no expert-established ground truth, was used for a test set.
4. Adjudication Method for the Test Set
Not applicable. No clinical testing was performed, so no adjudication method was used for a test set.
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
Not applicable. The CloudEKG is a hardware device for acquiring and transmitting EKG signals, not an AI-based interpretation system. No MRMC study was conducted, and no AI is mentioned for enhancing human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The CloudEKG is a hardware device, and its software focuses on signal processing and display, not standalone diagnostic interpretation. The document explicitly states: "No ECG interpretation for Poly-Spectrum.net software."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for clinical ground truth. For non-clinical performance, the "ground truth" was defined by industry standards (e.g., IEC 60601 series for medical electrical equipment and electrocardiographs) and functional specifications verified through hardware and software tests.
8. The sample size for the training set
Not applicable for clinical data. The device's software performs signal processing and display, not interpretation based on a trained model.
9. How the ground truth for the training set was established
Not applicable for clinical data. The device does not utilize a training set in the context of machine learning for diagnostic interpretation. Its "ground truth" for non-clinical testing was based on compliance with established engineering and safety standards.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).