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The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on adult patients and pediatric patients age 18 - 22 years. It is designed to be used by a patient or other layperson in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), to record and transmit a 12-lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.

The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The OT ECG system consists of 5 major components when using:

• The QT ECG Recorder - Compact device that records 12-lead, resting electrocardiograms, then transmits the recorded data to a mobile device (smartphone, tablet, etc.) paired via Bluetooth. A Bluetooth-enabled mobile device (not included) is needed to operate the QT ECG Recorder, and to send the recoded rhythm strip to a cardiologist or licensed physician for review.
• . The QT ECG Electrode Strip-Disposable, patented electrodes that are prepositioned on a self-adhesive strip
• . The QT ECG App — Software that lets the user uses their mobile device to operate the QT ECG recorder. Once an ECG recording is done, the data is auto uploaded to the cloud for analysis.
• . Analysis - The analysis module provides ECG measurement from the collected data.
• . Web Service - The web service provides an interface for communication.
  The recorded ECG data is saved temporarily on the mobile device until it is transferred via the Internet to the cloud server. The OT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is intended for use on adults and pediatric patients to acquire ECG signals to be transmitted wirelessly via Bluetooth to a mobile device, and then over the Internet to a web service. The QT ECG System is designed to be used by a patient to record and transmit ECG data to a physician's office, hospital or other medical receiving center for review.

This document describes the 510(k) Pre-market Notification for the QT ECG device. The purpose of the submission is to demonstrate substantial equivalence to a predicate device, Smartheart (K113514).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly present a single table of "acceptance criteria" alongside "reported device performance" for the entire device in a pass/fail format for all aspects. Instead, acceptance criteria are generally implied by adherence to recognized standards for non-clinical testing and by specific objectives for the clinical and usability studies.

However, a comparison table (pages 9-18) details the subject device's features against the predicate device, indicating "Equivalent" or "Identical" for most aspects, and elaborating on differences that do not raise new issues of substantial equivalence. For performance, the clinical study's objectives serve as acceptance criteria.

Clinical Study Acceptance Criteria & Performance:

Non-Clinical Testing Acceptance Criteria & Performance:

For non-clinical tests (Biocompatibility, Software Validation, EMC, Electrical Safety, Performance & Shelf life), the acceptance criteria are implicitly defined by compliance with the listed FDA-recognized standards (ISO 10993 series, IEC 62304, ISO 14971, IEC 60601 series, IEC 62133). The document states:

• "All the test results demonstrate QT ECG meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Page 6)
• The tables listing the standards (pages 6-7) serve as the acceptance criteria for these categories.

2. Sample Size Used for the Test Set and Data Provenance:

• Clinical Study (Study One): The document does not explicitly state the sample size (number of patients) used in Study One. It mentions "unselected population aged 18 to 75 years old."
• Data Provenance: The document does not specify the country of origin for the clinical study data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Clinical Study (Study One): The document mentions "clinical interpretation from patients... between Philips PageWriter and QT ECG." This implies that the interpretation of the ECGs from both devices was performed by experts, and their interpretations were compared to establish equivalence. However, the exact number of experts, their qualifications (e.g., "radiologist with 10 years of experience"), or how their interpretations formed a ground truth are not detailed in this document.

4. Adjudication Method for the Test Set:

• The document does not describe the adjudication method (e.g., 2+1, 3+1, none) used for the clinical interpretations in Study One.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• The document does not indicate that an MRMC comparative effectiveness study was done to measure human reader improvement with AI assistance. The clinical study aimed to show equivalence in clinical interpretation between the QT ECG and a reference device (Philips PageWriter), not the impact of AI assistance on human readers.

6. Standalone (Algorithm Only) Performance:

• The document does not present a standalone performance study of the algorithm without human-in-the-loop. The device's "Analysis module" provides "ECG measurement" (e.g., P, Q, R, S, T points and eight measurements), but its performance (e.g., accuracy against a reference standard) is not described as a standalone evaluation. The overall equivalence is based on the system's ability to produce interpretable ECGs.

7. Type of Ground Truth Used:

• Clinical Study (Study One): The ground truth for evaluating clinical interpretation equivalence was based on the interpretation of ECGs from a reference device (Philips PageWriter ECG system) compared to the QT ECG system. This suggests a comparative ground truth rather than an independent "gold standard" such as pathology or outcomes data.
• Non-Clinical Testing: Ground truth is established by adherence to the performance requirements outlines in the listed FDA-recognized standards (e.g., IEC 60601-2-25:2011 for basic safety and essential performance of electrocardiographs).

8. Sample Size for the Training Set:

• The document does not specify a sample size for a training set. This submission is for a device that acquires, records, and processes ECG signals for transmission and review, implying that the primary "analysis module" performs measurements rather than complex diagnostic AI that typically requires large training datasets. If an algorithm was trained, the details are not provided here.

9. How the Ground Truth for the Training Set Was Established:

• As no training set sample size is provided, the method for establishing its ground truth is also not described in this document.

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