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The function of the device is the acquisition and transmission of the ECG signal in order to support diagnosis of the patient's conditions.

HD+ is a wireless or USB (with appropriate option) ECG acquisition device, to be used primarily as common front-end for standard PC/tablet platforms (Windows/MAC OS/others), for resting ECG applications.

The device implements wireless communication vireless technology or wired with USB communication. With both connection modes, HD+ sends the data to the receiver device without performing any analysis or filtering. HD+ is not intended for monitoring of the cardiac function or to diagnose the patient's health condition. Display, print and analysis applications on the receiver device are separate products. HD+ is not able to permanently store the acquired data, therefore it does not work unless a connection has been established with a receiver application. Furthermore, HD+ does not collect any of the patient's name, age, previous health conditions etc.).

HD+ detects the QRS complexes and transmit the receiving device. The QRS detection function is intended for patients aged 12 years or older.

*HD+ is indicated for the acquisition of ECG signals with the patient in resting conditions, for example for diagnostic ECG's and rhythm strips

*HD+ is suitable for working at high altitudes, with restrictions.

*HD+ is intended for use on patients, with no limits of age or gender, except for the HR detector function which is intended for patients 12 years or older

• HD+ is intended for use in medical facilities (hospitals, clinics), at home or emergency settings (ambulances).

*HD+ is intended for use by a physician, nurse or other healthcare professional (e.g., ECG technician) who acts following orders by a physician or authorized nurse, including when operated in home environments

*HD+ is not intended for real-time monitoring of vital physiological parameters.

HD+12 and HD+15 are the new revisions of Cardioline's HD+ wireless acquisition module. The HD+ is a digital portable acquisition device which can acquire the electrocardiographic signal of 12 and 15 standard leads. Connected with a receiver via Bluetooth or USB (with the optional USB connector), the HD+ performs no analysis or filtering but sends acquired data to a host application where the User Interface is implemented. By default, the device includes a demo compatible software "HD+ Display" whose purpose is providing a UI for viewing the traces acquired by HD+. HD+ Display provides a simple UI, sufficient to configure the application to connect to an HD+ device via Bluetooth (the application automatically detects if an HD+ device is connected via USB and does not require additional configuration) and sufficient to display the ECG traces as received by HD+. HD+ Display does not provide any clinical functionality; therefore, it does not provide any capability to store, print or analyze the acquired ECG.

lt is the host (PC or Tablet separated by HD+) which performs the analysis. HD+ is not intended to control or analysis heart function and/or to diagnose the patient's health status. The analysis program on the host is a separate product not marketed with the HD+.

HD+ is a wireless acquisition device, to be primarily used as ECG front-end acquisition device for PC/tablet (Windows/MAC OS/Android/iOS/others) standard platforms for Resting ECG applications. Depending on performance/price ratio, HD+ could be also used with selected embedded electrocardiographs. HD+ allows the patient to be ambulatory.

HD+ uses a standard Bluetooth data transmission technology to transmit 12-lead and 15-lead ECG data over a proximity range, providing electrical insulation and freedom of movement for the patient. The device implements the wireless communication via Bluetooth wireless technology. The Bluetooth radio protocol is implemented by a dedicated module, FCC compliant. In order to support the data transmission speed of the application, the device implements the BLE 5 protocol with DLE (Data Length Extension) and 2M PHY (bandwidth up to 2 Mbit/s). The minimum specifications of the device connected to HD+ is BLE 4.2 to support the band required by acquisitions at 500 s/s. In order to operate at 1000 s/s, the connected device must be BLE 5.0 (or higher) and have a compatible 2M PHY radio (2 Mbit/s). Alternatively, in addition to Bluetooth connectivity described above, the HD+ has an optional USB interface that can be used to transmit data. The USB interface provides an electrical insulation offering two means of patient protection (2MPP), allowing HD+ to be connected to any IT equipment conforming to IEC 62368-1.

The HD+ function consists of acquiring and transmitting ECG signals for display processing ECG signals for the purpose of supporting the diagnosis of patient conditions. The device does not store nor does it associate patient identification data to the acquired signal, nor does it perform analysis on such signal. The HD+ is used solely for transmission of ECG signals from patient to a host analysis platform.

The HD+ transmits a continuous stream of ECG samples at a rate of 500 s/s or 1000 s/s, with a resolution of 0.817 uV/LSB or 2.495 uV/LSB, selectable by the calling application of the host analysis platform. The average required transmission throughput for sending 15 leads at 1000 s/s is approximately 155kbit/s, while to send 12 leads at 500 s/s the required throughput is approximately 54 kbit/s. BLE 5 2M PHY provides the bandwidth needed to support the maximum required throughput.

The BLE communication link ensures that data is either received correctly or not received at all. It is up to the host application to detect packet losses, handling the data gaps appropriately (e.g. by filling the stream with invalid dummy samples, signaling transmission errors etc...). This approach has been preferred over enabling the data retransmission (supported by the module) to reduce the data iitter and transmission delay.

HD+ uses standard 12 lead or 15 lead ECG cables to acquire the physiological signal from the patient. HD+ is light and compact, comfortable to wear, minimizing motion artifacts caused by traditional electrodes and patient cables.

HD+ offers full ECG acquisition - meeting the standards used in clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). HD+ uses a LED indicator to comfortably monitor the link status (off when unit is powered down, blinking when unit is attempting to connect with the receiver, steady when unit is connected with the receiver). HD+ uses a programmable key to send macro commands to the receiving system (i.e. acquire and print an ECG). Low-power technology allows continuous usage of the device for more than 10 hours (from full battery charge).

The HD+ continuously transmits the acquired data to a computer platform where compatible software, a Host Application authorized by Cardioline, is installed that acts as its User Interface. As an example of such Host Application, the device includes a compatible demo Windows application "HD+ display" from Cardioline to visualize the ECG traces and check the functionality of the results of the analysis must always be validated by qualified, trained medical personnel and the HD+ is intended for use in a medical environment. HD+ is intended to be used on adult and all pediatric patients. The device must be handled with care by taking all the necessary precautions in order to prevent and avoid shocks, vibrations, heat sources, liquids and anything else that may damage it.

The provided text is a 510(k) summary for a medical device (Cardioline HD+12, HD+15), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than proving a device meets specific acceptance criteria through a clinical study in the way an AI/ML algorithm might.

Therefore, the document does not contain details about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML algorithm's performance. The device described in the document is an ECG signal acquisition and transmission device, explicitly stating that it "sends the data to the receiver device without performing any analysis or filtering" and "is not intended for monitoring or analysis of the cardiac function or to diagnose the patient's health condition." It also mentions that "clinical evaluation is not required" because it's an acquisition device without analysis, diagnosis, or monitoring features.

However, I can extract information related to performance testing conducted to support the substantial equivalence claim, which serves a similar purpose to meeting acceptance criteria for a non-AI/ML device.

Here's an analysis based on the provided text, while acknowledging that it doesn't align with the detailed AI/ML study requirements in the prompt:

Acceptance Criteria and Device Performance (for a non-AI/ML acquisition device)

The document primarily focuses on demonstrating that the new devices (HD+12, HD+15) are substantially equivalent to a predicate device (HD+) by showing adherence to relevant standards and similar performance characteristics. The "acceptance criteria" here are essentially compliance with safety and performance standards for a physiological signal acquisition device.

1. Table of Acceptance Criteria (based on standards compliance and comparative features):

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