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The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.

• Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
  The system provides 12-lead ECG and interpretive analysis.
  The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
  Sending and receiving ECG data to and from the Hospital Information System is optional.
  The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
  In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.

Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.

The provided document is a 510(k) summary for the Cardio Q50 and Cardio Q70 ECG Analysis System, which includes both ECG and spirometry functions. The document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner you've requested.

However, based on the information provided, I can infer some aspects related to acceptance criteria and how the device's performance is demonstrated:

1. A table of acceptance criteria and the reported device performance

The document does not provide a direct table of acceptance criteria with reported device performance metrics in terms of accuracy, sensitivity, specificity, etc., for the diagnostic algorithms. Instead, it states that the device complies with certain international standards. Compliance with these standards implicitly serves as the acceptance criteria for various aspects of the device's functionality and performance.

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

The document does not provide details on sample size, data provenance (e.g., country of origin, retrospective/prospective), or demographic information for any test sets used to validate the performance of the Bionet or Glasgow ECG analysis algorithms. It mentions "Non-Clinical Test Summary" and "Clinical Test Summary" but states "Clinical testing is not required." This implies that the device's performance regarding the ECG interpretation algorithm itself was likely established based on prior validation of the algorithms (Bionet algorithm V 3.26 and Glasgow algorithm V 30.4) outside the scope of this specific 510(k) submission, or that the FDA did not require new clinical data for this particular clearance due to substantial equivalence.

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 because no specific clinical study data is presented for the ECG analysis algorithm. The document mentions that the interpretive analysis "must be confirmed by a qualified medical professional along with other relevant clinical information." This highlights the human-in-the-loop nature of the device's intended use rather than providing details on ground truth establishment for an algorithm's validation.

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

This information is not provided as no specific clinical study data (including ground truth establishment) is detailed in the document.

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

The document does not indicate that an MRMC comparative effectiveness study was performed or refer to any such study demonstrating the effect size of human readers improving with AI assistance. The device's clearance is based on substantial equivalence to existing devices and compliance with relevant standards, not on a demonstrated improvement in human reader performance.

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

While the document states that the ECG interpretation algorithm provides analytical information that "must be confirmed by a qualified medical professional," it also includes the algorithm as a feature. The compliance with standards like ANSI AAMI EC53 (Ambulatory ECG Recorders) might implicitly cover some standalone algorithm performance metrics, but no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy of the algorithms) are explicitly provided in this 510(k) summary. The document focuses on the safety and essential performance of the electrocardiograph system as a whole, rather than the isolated diagnostic performance of its interpretive algorithms.

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

The document does not specify the type of ground truth used for the validation of the Bionet or Glasgow ECG analysis algorithms, as details of a specific validation study are not included in this submission. For ECG interpretation algorithms, ground truth is typically established through expert consensus by multiple cardiologists, often aided by correlation with other clinical data and patient outcomes.

8. The sample size for the training set

The document does not provide information on the sample size for the training set of the ECG analysis algorithms.

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

The document does not describe how the ground truth for the training set was established. This information would typically be part of the algorithm's development and validation, which precedes the 510(k) submission for a device incorporating a previously developed or updated algorithm. The document only states the versions of the Bionet (V 3.26) and Glasgow (V 30.4) algorithms being used, implying their prior establishment and validation.

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The ECG Acquisition Systems is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to vhECG Pro, which installed in iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12-lead ECGs.

The ECG Acquisition Systems is for use on adult and pediatic populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor.

The subject device is intended to be used for clinical use rather than home use. It can be used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance.

The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.

The ECG Acquisition Systems is a hand-held, battery powered, 12-lead resting electrocardiograph system with vhECG Pro software. The ECG Acquisition Systems consists of ECG Acquisition Recorder, Patient Cable and vhECG Pro software. ECG data is transferred via Bluetooth® 4.0 Technology and displayed on mobile screen in real-time before, during and after acquisition. With vhECG Pro, resting ECGs can be recorded, viewed and printed in various formats. Besides, ECGs can also be uploaded to vhCloud ( cloud platform) by vhECG Pro, they can be reviewed by other medical staff authorized via its iPhone or iPad in which vhCloud is installed. The device is intended to provide reference for medical diagnosis, not intended for a replacement of diagnosis of clinicians.

The provided text is a 510(k) Summary for the "ECG Acquisition Systems" device. It describes the device, its intended use, comparison to a predicate device, and results of nonclinical tests. However, it explicitly states that clinical data is not applicable for this submission and does not contain any information about a study proving the device meets specific acceptance criteria based on clinical performance metrics (like sensitivity, specificity, or reader improvement with AI).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical performance study is described in the provided document. The document focuses on demonstrating substantial equivalence through nonclinical testing (electrical safety, EMC, QoS, wireless coexistence, ECG performance, patient cable performance, and software verification/validation) and comparison of technological characteristics to a predicate device, not on diagnostic accuracy or efficacy studies involving human readers or AI.

The response below reflects what could be extracted if such a study were present, but indicates the absence of this information in the provided text.

This document outlines the substantial equivalence of the "ECG Acquisition Systems" to a predicate device for FDA 510(k) clearance. It specifies the device's technical characteristics and nonclinical test results. However, it explicitly states that "Clinical data is not applicable for this submission." Therefore, the provided text does not contain information about acceptance criteria for clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI) or a study that proves the device meets such criteria through clinical evaluation.

The document primarily relies on nonclinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study.

Here's what can be gathered, alongside the confirmation that the requested clinical performance study details are absent:

1. Table of Acceptance Criteria and Reported Device Performance:

As no clinical performance study is described, there are no acceptance criteria for metrics like sensitivity, specificity, or other diagnostic performance indicators. The "acceptance criteria" discussed in this document pertain to adherence to technical standards and nonclinical test results.

2. Sample size used for the test set and the data provenance:
No clinical test set data is described. The nonclinical tests refer to compliance with technical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical performance test set or ground truth establishment by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.

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, as the device provides "uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis" and does not involve AI assistance for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as the device primarily acquires and displays raw ECG data, and does not provide automated interpretation (explicitly states: "The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.").

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical performance study requiring ground truth is described.

8. The sample size for the training set:
Not applicable, as the document does not describe a machine learning model or a training set.

9. How the ground truth for the training set was established:
Not applicable.

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