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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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