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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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touchECG is designed to check and diagnose cardiac function. However, a physician must validate the results of the analysis run by the ECG.

touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use by health professional in emergencies (ambulances).

touchECG is intended to be used in conjunction with CARDIOLINE HD+ device.

• The device analyzes, displays and prints out electrocardiograms. The ECG's are acquired from CARDIOLINE HD+ device.

• The device interprets the data for review by a physician.

• The device must be used by a physician or by health professionals on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis.

• The device's interpretation of the ECG analysis is only significant if used together with an additional analysis by the physician and by an assessment of all the patient's important data.

• The device can be used on adults patients.

• The device must not be used as a physiological monitoring of vital signs.

touchECG is a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function. However, the results of the analysis run by the ECG must be validated by a Cardiologist.

touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use in emergencies (ambulances).

touchECG is intended to be used in conjunction with CARDIOLINE HD+ device (K150289). The CARDIOLINE HD+ device is the device that acquire the ECG signal and send it, via Bluetooth, to the PC in which the touchECG software is installed. touchECG software is designed to works solely with CARDIOLINE HD+ device. The analysis of ECG traces and the automatic interpretation are performed on the PC, and must always be validated by a Cardiologist. The device can't do diagnosis by itself, but only shows the results of interpretation according to Glasgow program.

The device must be used by a doctor or by specialized staff on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis.

touchECG is a 12-lead diagnostic electrocardiograph which displays, acquires, prints and stores ECG traces for adults. It also calculates the principal global ECG parameters.

The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with specific criteria for patients of different age, sex and race. If this option is enabled, the algorithm can provide the physician of reference with an automatic interpretation generating diagnostic messages in the ECG report.

For further information on the resting ECG interpretation algorithm, see the Instruction Manual for doctors for its use with adults.

In the touchECG software, the subject device, the Glasgow Interpretation Algorithm is always loaded on the device. It can be enabled or not, depends on the customer request. Only Cardioline can enable or disable the Glasgow Algorithm.

In case the Glasgow is disabled the text of the automatic interpretation is not printed, but the measurements on the ECG traces are executed by the Glasgow algorithm.

The device installs on any PC, tablet or notebook with the minimum requisites shown below:

Operating System - Windows 7, Windows 8.1, Windows 10

Processor - Intel 15 or higher

RAM - 4GB or more

Free space on Hard Disk - 3GB or more

Monitor - 640 x 480 pixel or more

Bluetooth - Bluetooth 2.1 +EDR

Printer - Laser (colour/BW)

Printing paper: A4, Letter

Interpretation Algorithm: Glasgow algorithm

Additional applications - Email application which supports the EML format (only required for the email File Upload feature)

It prints out in the following formats: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channel in automatic mode, and 3, 6 or 12 printout channels of the rhythm strip.

The device doesn't have other hardware components or accessories. touchECGis intended to be used in conjunction with CARDIOLINE HD+ device (K150289 that acquires the ECG signal and transmits it.

touchECG is a software medical device provided on a CD support

The provided text describes the Cardioline touchECG, an interpretative electrocardiograph intended for use with the CARDIOLINE HD+ device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that performance tests were conducted following IEC 60601-2-25:2011, suggesting that compliance with this standard serves as the primary acceptance criterion. The text then lists specific performance aspects that "were passed."

2. Sample size used for the test set and the data provenance:

The document states: "Performance test are performed following the standard IEC 60601-2-25." It then mentions that these tests were verified by "printing the screenshot taked by the touchECG," and that "All these screenshot are present in the file 031_510_TR_PR_TouchECG3_1402_00_eng_attachments_cardioline_touchECG.PDF and the explanation of all printed test is present on file 536 IEC60601-2-25 results performances list, both attached to the submission."

• Sample Size for Test Set: The number of test cases or ECGs used for the performance verification is not explicitly stated in the provided text. It only refers to a "file 536 IEC60601-2-25 results performances list" which would presumably contain this detail.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. The testing appears to be primarily technical performance verification against a standard, not necessarily involving a clinical study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The performance tests described (e.g., defibrillation protection, noise level, linearity) are typically evaluated against technical specifications within the IEC 60601-2-25 standard, rather than requiring expert adjudication of clinical ground truth for each test case.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided as the performance tests outlined against IEC 60601-2-25 are typically objective measurements against technical criteria rather than consensus-based adjudication.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device's interpretation algorithm (Glasgow algorithm) is present, but no study on its comparative effectiveness with or without AI assistance for human readers is described. The device's interpretation is explicitly stated to always be validated by a cardiologist and is "not intended as the only means for determining the diagnosis," suggesting a human-in-the-loop workflow, but without a formal study on its impact.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document states: "The device interprets the data for review by a physician." and "The device's interpretation of the ECG analysis is only significant if used together with an additional analysis by the physician and by an assessment of all the patient's important data." This strongly implies that the device is not intended or validated for standalone performance in a diagnostic context. Its role is to provide an interpretation that a physician must validate. While the Glasgow algorithm provides an interpretation, its performance in isolation is not separately evaluated or presented as a standalone diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the technical performance verification against IEC 60601-2-25, the "ground truth" would be the technical requirements defined by the standard itself (e.g., a specific frequency response range, a maximum noise level).

For the embedded Glasgow interpretation algorithm, the document does not describe how its internal ground truth was established, only that it is the "same interpretation algorithm of Mindray Passport Series." The document does not provide details on the validation of the Glasgow algorithm itself, only the overall device's compliance with a technical standard.

8. The sample size for the training set:

The document mentions that the device uses the "Glasgow Interpretation Algorithm." However, no information is provided regarding the training set size for this algorithm, nor for any other machine learning component within the touchECG for which training would be applicable. The document focuses on the integrated device performance, not the internal development or training of the interpretation algorithm.

9. How the ground truth for the training set was established:

Since the document does not provide information on the training set for the Glasgow Interpretation Algorithm, it also does not describe how the ground truth for any such training set was established.

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ECGxxx(z)(+) is a high-performance, multi-channel, interpretative resting electrocardiograph.
The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer.
ECGxxx(z)(+) is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.
ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and doctor's offices of any size.

• The device is indicated for use to acquire, analyse, display and print electrocardiograms.
• The device is intended to provide the physician with an automatic interpretation of the ECG to be reviewed by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
• The device is indicated for use on adult and pediatric populations.
• The device is not intended to be used as a vital signs physiological monitor.

ECGxxx(z)(+) is a family of high-performance, multi-channel, interpretative resting electrocardiograph. ECG100+ and ECG200+ are two models of that electrocardiographs family.
The device is a 12-lead diagnostic electrocardiograph which displays, acquires, prints and stores EGG tracings for adults and children. It also calculates the main overall ECG parameters.
The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with specific criteria by age, sex and race. If this option is enabled, the algorithm can provide an over-reading physician with a second opinion generating diagnostic messages in the ECG report.
For further information on the resting ECG interpretation algorithm, see the Guidance for the physician on the application on adults and children (see accessories list)
The device can be configured with a larger memory, with bidirectional connectivity (LAN) and with DICOM® functionality.
The device can be powered by battery or the electrical mains.
The printing formats supported include: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channels in automatic mode and 3, 6 or 12 (only for ECG200+) channels rhythm strip printing.
The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyze and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer.
ECGxxx(z)(+) is intended for control and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Cardiologist.
ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and offices of any size.
ECGxxx(z)(+) is a family of electrocardiographs which are a 12-lead diagnostic electrocardiographs and which are intended to displays, acquires, prints and stores ECG tracings for adults and children. It also calculates the main overall ECG parameters.
The devices have the following characteristics:

• mains and internal battery operation
• manual and automatic acquisition of the 12 Standards Leads
• simultaneous acquisition of the 12 Standards Leads
• internal storage up to 100 ECGs. Can storage up to 1000 ECGs optionally
• multichannel ECG printout on thermal paper:
  • a) (for ECG100+) 3, 6 channels, 5/10/25/50 mm/s
  • b) (for ECG200+) 3, 6 or 12 channels, 5/10/25/50 mm/s
• high resolution thermal printer:
  • a) (for ECG100+) 8 dot/mm 108mm; Z-fold 100x150mm
  • b) (for ECG200+) 8 dot/mm 216mm; A4 Z-fold
• for autoprint mode:
  • a) (for ECG100+) Standard or Cabrera; 3, 3+1, 6 channels Patient Demographic, Global Measurements, Optional Interpretation (Glasgow University - Prof. MacFarlane) Adult, Paediatric, STEMI
  • b) (for ECG200+) Standard or Cabrera; 3, 3+1, 6, 12 channels Patient Demographic, Global Measurements, Optional Interpretation (Glasgow University - Prof. MacFarlane) Adult, Pediatric, STEMI
• display:
  • a) (for ECG100+) Backlit, colour LCD display, 4.3" ECG waveform real-time tracing
  • b) (for ECG200+) 7" backlit LCD colour display, displays the ECG waves in real time
• Keyboard (for both devices): Mechanical keypad with alphanumeric keys and special function keys -
• filters (for both devices): diagnostic fully digital high pass filter; adaptive digital AC interference filter (50/60 Hz); digital low pass filter muscular filter 25 and 40 Hz (only for display and printing)
• connectivity (for both devices): USB device and LAN (optional)
• patient cable (for both devices): standard 15D, 10-wires
• -Data export (for both devices): SCP (standard format), XML-PDF-GDT (included in standard connectivity option), DICOM (included in DICOM connectivity option), HL7 (optional).
  More specifically, the equipment family is based on two model variants characterized by different print and display capabilities.
  Both devices offers full ECG acquisition meeting the standards used in clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). When battery powered both devices have a duration of more than 500 ECGs and the recharging time is 4 hours to 85% of full charge.
  The package includes (for both devices):
• 1. Patient cable
• 2. AC Power supply (100-240 VAC 50/60 Hz)
• 3. Paper
• 4. Pack of electrodes
• 5. Banana/clip adapter set
• 6. Guidance for the physician on the application on adults and children (with interpretative key)
• 7. User manual
     The common family name is ECGxxx(z)(+). Where:
     xxx = printer size
• • = model with network connectivity
• z = models with different interfaces
  (refer to Technical File for more details)
  The results of the analysis must always be validated by qualified, trained medical personnel and the devices are intended for use in a medical environment. ECG100+ and ECG200+ are intended to be used on adult and all pediatric patients. The devices 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 document is a 510(k) premarket notification for the Cardioline ECG100+ and ECG200+ electrocardiographs. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's diagnostic algorithm performance.

Therefore, many of the requested details about acceptance criteria, specific study designs, and ground truth establishment for an AI performance study are not present in this document. The document describes the device's physical and functional performance, as well as its safety and EMC compliance, but not the clinical performance of its automatic interpretation algorithm in a standalone or MRMC study.

Here's a breakdown of what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical accuracy or diagnostic performance for the ECG interpretation algorithm. Instead, it demonstrates compliance with relevant safety and performance standards for electrocardiographs.

The performance aspects highlighted are related to the physical and electrical functioning of the device, not the diagnostic accuracy of its interpretation algorithm.

Information Not Found in the Document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This document does not contain information about a dedicated test set for evaluating the diagnostic performance of the interpretation algorithm. The "performance data" section focuses on hardware and electrical aspects, not clinical algorithm accuracy.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable, as no dedicated test set for diagnostic accuracy is described. The document states that the interpretations must be validated by a Physician/Cardiologist.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable, as no specific test set requiring adjudication is described.

4. 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 is mentioned. The device's interpretation algorithm (Glasgow ECG system) is presented as an "optional interpretation" intended to "provide the physician with an automatic interpretation of the ECG to be reviewed by a physician." It explicitly states: "The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data." This indicates it's an assistive tool, but no study on its effectiveness in improving human reader performance is provided.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The document implies the algorithm provides an interpretation, but no standalone performance study results (e.g., sensitivity, specificity for specific conditions) are provided. Its role is clearly defined as "not intended as a sole means of diagnosis" and requiring "a physician over-read."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not specified for the interpretation algorithm's development or validation.

7. The sample size for the training set:

   • The document mentions the device can be supplied with the "optional 12-lead Glasgow resting ECG interpretation algorithm." The training set size for this pre-existing algorithm (developed by Glasgow University - Prof. MacFarlane) is not discussed in this submission.

8. How the ground truth for the training set was established:

   • As with the training set size, the method for establishing ground truth for the Glasgow algorithm is outside the scope of this 510(k) submission and not detailed here.

Summary of what the document does provide regarding the interpretation algorithm:

• Algorithm Name: Glasgow resting ECG interpretation algorithm (adult and pediatric).
• Provider: Glasgow University - Prof. MacFarlane.
• Function: Provides a "second opinion" or "diagnostic support" to the physician.
• Limitation: "Interpretation Statements must be overviewed and approved by trained Physician's. Interpretation statements just represent a partial qualitative and quantitative information of the general patient cardiovascular condition: no therapy or drugs can be subministrated based solely on Interpretation statements." Also, "It is not intended as a sole means of diagnosis." and "must be validated by a Physician."
• Target Population: Adult and pediatric.

This 510(k) submission focuses on demonstrating that the new Cardioline ECG devices are substantially equivalent to existing, legally marketed ECG devices in terms of general function, safety, and physical performance, including the capability to run a similar interpretation algorithm. It does not provide the detailed validation study of the embedded Glasgow interpretation algorithm itself.

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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.

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.

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