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KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is intended to be used by doctors and/or trained healthcare professionals in a hospital, medical professional's facility, clinic, physician's office or any medical outreach center. The device can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis.

KardioScreen is a portable battery-operated electrocardiograph designed to acquire either a 6lead or 12-lead resting, diagnostic electrocardiogram (ECG) using surface electrodes from adult patients and pediatric patients aged 14-21 years. The device consists of the following three (3) parts:

• 1. Electrodes and patient cable with KardioScreen Converter
• 2. KardioScreen device
• 3. KardioScreen application running on Android tablet

The device is supplied with patient cables with lead wires that connect to any commercially available disposable ECG electrode. Optional reusable clamp electrodes can be used for the limb leads and bulb electrodes for the chest leads.

Once the electrodes have been connected to the patient, the ECG cable with KardioScreen Converter is then connected to the "ECG" port on the KardioScreen device. This module receives the electrical ECG signals, performs processing on the signals and then wirelessly transmits the ECG data through a Bluetooth Low Energy (BLE) interface to a mobile application running on an Android tablet. The ECG waveforms are displayed on the KardioScreen application for viewing and analysis. From the Android tablet, the ECG report can be printed or exported for external use.

The provided document, a 510(k) Premarket Notification from the FDA for iMedrix Inc.'s KardioScreen, primarily focuses on demonstrating substantial equivalence to a predicate device. It explicitly states that no clinical data were submitted to support the substantial equivalence of KardioScreen to the predicate device and that no animal testing was submitted.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning device performance for diagnostic purposes.

The document details non-clinical testing performed to support substantial equivalence, such as:

• Electrocardiograph safety and performance
• Electrical safety
• Electromagnetic compatibility (EMC)
• Wireless co-existence testing
• Software verification and validation
• Usability validation
• Biocompatibility

These tests are crucial for safety and foundational functionality but do not provide data on the diagnostic performance of the device itself (e.g., its accuracy in detecting heart conditions).

In summary, as per the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "No clinical data were submitted."
• 2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study data is presented.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 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: Not applicable. The document describes a device for acquiring ECGs, not an AI-assisted diagnostic tool that interprets or enhances human reading.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable, as no clinical performance study data is presented.
• 9. How the ground truth for the training set was established: Not applicable.

The FDA's clearance of KardioScreen via this 510(k) is based on its substantial equivalence to a legally marketed predicate device (Edan Instruments, Inc.'s PADECG) for its described indications for use, without the need for new clinical performance data to demonstrate diagnostic accuracy. The device "can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis." This wording indicates it's a data acquisition and display tool, and its diagnostic utility relies on interpretation by a healthcare professional, not an automated diagnostic claim from the device itself.

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