(203 days)
HD+ is a physiological ECG acquisition module. HD+ transmits wireless, via Bluetooth to a PC or Tablet, the data acquired, without making any analysis or filtering on the data acquired.
HD+ acquires 12-lead ECG waveforms meeting the standards for clinical and diagnostic applications (AAMI, ANSI, AHA, ACC) and offers full ECG acquisition.
HD+ is designed to acquire and transmit a high quality ECG data allowing the patient to be free to moving (without cable connected to the processing unit).
The HD+ transmits the acquired physiological signals in real-time to a computer/device where a compatible application is installed.
All data acquired are sent via Bluetooth to a receiver that it can be a PC, tablet or device capable of receiving BT data. The ECG is transmitted verbatim to the receiving system, without LSB or sampling adjustment. It is up to the receiving system/application to perform the necessary processing such as (but not limited to) LSB scaling, signal filtering, Resting ECG analysis etc ...
The device HD+ is intended to be used on adult and on all pediatric patients.
The device is intended for use by qualified, trained nurses and physicians operating in hospitals, clinics and medical practices.
The HD+ is a digital portable acquire which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the host but doesn't make any analysis or filtering. It's the host (PC or Tablet separated by HD+) which make the analysis. HD+ is not intended to control or analysis heart function and/or to diagnose the patient's health status. 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 common ECG front-end for PC/tablet (Windows/MAC OS/other) standard platforms (both for Resting ECG and Stress ECG applications). Depending on performance/price ratio, HD+ could be also used with selected embedded electrocardiographs.
HD+ allow the patient to be ambulatory.
HD+ uses a standard Bluetooth data transmission technology to transmit 12-lead ECG data over a proximity range, providing perfect 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 chipset developed by Bluegiga Technologies (WT-12). The device is a BT 2.1 compliant device. Its rated emission power is 3.46 dBm and uses the Bluetooth radio bandwidth (2402-2480 Hz, 79 channels).
The device function consists of acquiring and wirelessly transmitting ECG signal for displaying, processing and presenting ECG signal for the purpose of supporting the diagnose of patient conditions.
The device does not store nor does associate patient identification data to the acquired signal, nor does it perform analysis on such signal.
The device transmits a continuous stream of ECG samples at rate of 500 s/s and a resolution
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Cardioline HD+ device:
Based on the provided 510(k) summary for the Cardioline HD+ (K150289), the device is a physiological ECG acquisition module that wirelessly transmits acquired data without performing analysis or filtering. Therefore, the "acceptance criteria" discussed in the document are primarily related to technical performance standards and safety/EMC compliance, rather than clinical performance metrics often associated with AI/analysis devices (like sensitivity, specificity, or reader improvement).
1. Table of Acceptance Criteria and Reported Device Performance
Since this device is a data acquisition and transmission module without analytical capabilities, the acceptance criteria are based on adherence to established medical device standards for ECG acquisition. The document doesn't provide a direct "acceptance criteria" table with specific pass/fail values for each parameter, but it lists the standards and the performance tests carried out.
| Acceptance Criteria Category / Parameter | Reported Device Performance |
|---|---|
| Safety Standards Compliance | Full compliance with IEC 60601-1 and IEC 60601-2-25. |
| Electromagnetic Compatibility (EMC) | Full compliance with EN 60601-1-2 standard. |
| Radio/Wireless Standards (Bluetooth) | Compliance with ETSI EN 301 489-1, ETSI EN 301 489-17, and FCC CFR 47 Part 15 rules. |
| ECG Performance (IEC 60601-2-51) | Tests performed on: Patient Derivation Polarity, Minimum System Switch Leads, Goldberger and Wilson Derivations, Input Impedance and Circuit Lead, Common Mode Rejection, Noise Level, Writing Speed and Trace Width, Channels Interaction, High Frequency Response, Low Frequency Response, Linearity and Dynamic Range, Minimal Signal Response, Sampling and Resolution, Recording Speed, ECG Distortion, Impulse Visibility of Pace-Maker, Internal Electrical Source Requirements. (All indicated as "Test have shown full compliance with this standard" implicitly for previous items, and "performance test are carried out... according to IEC 60601-2-51" implying satisfactory results for these parameters). |
| Sampling Rate | 1000 samples/second/channel for analysis (compared to predicate device values of 500 s/s). |
| A/D Conversion | 24 bit (compared to predicate device 11 bit and unspecified). |
| Data Resolution | 20 bit, 100 dB for one predicate, and unspecified for another). |
| Battery Life | 10 hours (compared to 30 hours and > 7 hours for predicates). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "HD+ is only an acquisition device without an analysis, diagnosis and monitoring features, so is not expected clinical evaluation." (Page 10)
Therefore, no clinical test set (i.e., human patient data for diagnostic accuracy assessment) was used. The "test set" in this context refers to the device itself being subjected to engineering and electrical performance tests. The data provenance would be laboratory testing in an engineering environment, not from human subjects or countries of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that no clinical evaluation was performed, there was no ground truth established by medical experts in the traditional sense for diagnostic accuracy. The "ground truth" for the engineering performance tests is the defined specifications and limits within the cited international and national standards (e.g., IEC, EN, FCC). The "experts" involved would be qualified test engineers and technicians performing the standard compliance tests.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring medical expert adjudication. The compliance tests are objective measurements against established standard specifications.
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. This device is a pure data acquisition and transmission module, not an AI or analysis tool. It does not provide any interpretation or diagnostic assistance to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. The HD+ itself does not contain any algorithms for analysis, diagnosis, or interpretation. It merely acquires and transmits raw ECG data.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for performance validation relates to engineering standards and specifications. For instance, the ground truth for "sampling rate" is 1000 samples/second/channel, verified by direct measurement. The ground truth for "CMRR" is 115 dB, verified by testing against the definition of Common Mode Rejection Ratio under specific conditions. There is no clinical "ground truth" (like pathology or expert consensus on diagnosis) that its performance would be measured against, as it performs no diagnostic function.
8. The Sample Size for the Training Set
No training set was used. The device does not employ machine learning or AI algorithms that would require training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).