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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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SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements is offered to clinicians on an advisory basis only. It is mainly used in the ECG Outpatient Department and Physical Examination Department.

SE-1515 is a PC-based ECG designed to acquire, process and store ECG signals and analyze and diagnose heart disease. SE-1515 consists of analysis software and sampling boxes, and has four configurations: Wired 18-lead ECG system, Wired 16-lead ECG system, Wired 12-lead ECG system and Wireless 12-lead ECG system. Wired 18-lead ECG system consists of analysis software and wired DE18 sampling box. Wired 16-lead ECG system consists of analysis software and wired DE15 sampling box. Wired 12-lead ECG system consists of analysis software and wired DP12 sampling box. Wireless 12-lead ECG system contains analysis software, wireless DX12 sampling boxes (DX12 transmitter and DX12 receiver). The communication between DX12 transmitter and DX12 receiver is based on Bluetooth technology. For stress exercise testing, the user should connect a BP monitor and a treadmill or an ergo meter to the PC.

Here's a breakdown of the acceptance criteria and the study information for the EDAN Instruments, Inc. PC ECG, model SE-1515, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating
substantial equivalence to predicate devices, not necessarily a detailed clinical
effectiveness study itself. Therefore, specific details about acceptance criteria, ground truth
establishment (especially for a new algorithm), and effect sizes from MRMC studies are often
not explicitly stated in this type of document. The information below is extracted directly
from the text; if a point is not mentioned, it's because the document does not provide it.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" but rather compares the performance parameters of the SE-1515 with its predicate devices (SE-1010, Philips DXL 12/16-lead ECG Algorithm, Philips TC70). The implicit acceptance criteria are that the new device's performance should be similar or comparable to the predicate devices, or that any differences do not raise new questions of safety or effectiveness.

Below is a table summarizing the performance comparison, highlighting where quantitative parameters are presented. Since "Remark" column indicates "Same," "Different," or "---", for the purpose of showing "acceptance criteria" and "reported device performance", the "predicate value" can be considered as the implicit acceptance criteria that the new device needs to meet to establish substantial equivalence.

Study Information:

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

   • The document mentions "database testing" for ECG interpretation features but does not specify the sample size for this test set or the provenance (country of origin, retrospective/prospective nature) of the data.

2. 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 document refers to "ECG interpretation features... validated by database testing," but details on the ground truth establishment for this validation are absent.

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

   • This information is not provided in the document.

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:

   • An MRMC comparative effectiveness study, particularly one measuring human reader improvement with AI assistance, was not indicated. The comparison is mainly against predicate devices, focusing on technical specifications and substantial equivalence, not algorithm-assisted human reading.

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

   • The document states, "ECG interpretation features were also validated by database testing." This implies a standalone performance evaluation of the algorithm against a database, though details are missing. The device's indications for use also state that the "ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," suggesting a standalone interpretive function.

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

   • For the "ECG interpretation features," the document mentions "database testing." However, the specific type of ground truth used within this database (e.g., expert consensus diagnoses, correlation with patient outcomes, or other clinical data) is not specified.

7. The sample size for the training set:

   • The document does not specify a training set and its size. The validation focuses on the device's performance and ECG interpretation features using "database testing."

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

   • Since no training set is explicitly mentioned or described, the method for establishing its ground truth is also not provided.

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