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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 infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), and in professional healthcare facilities (such as clinics, hospitals, and ambulances) 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 non-defibrillator-proof, hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The QT ECG system consists of 5 maior components:

• 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 recorded 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, then send the recorded data via cloud to a certified medical professional for review.
• Analysis The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, QRS duration, etc.
• 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 QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), and in professional healthcare facilities (such as clinics, hospitals, and ambulances) 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 provided text describes the QT ECG (QTERD100) device and its submission for FDA clearance. The submission, K233521, is a Special 510(k) comparing the device to a previously cleared version (K220795). The changes primarily relate to an expanded indication for use to include Emergency Medical Services (EMS) environments and updated environmental operating conditions and supported mobile devices.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison between the subject device (K233521) and the original device (K220795), focusing on the differences. The "Acceptance Criteria" column explicitly states the criteria for the tests conducted to validate these differences.

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

The provided document does not specify sample sizes for any of the tests mentioned (e.g., IEC 60601-1-12, software tests).

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The document mentions tests being conducted "according to IEC 60601-1-12," which implies standard compliance testing, but doesn't detail the origin of the test data.

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

The document does not provide information regarding the use of experts to establish a ground truth for the test set, nor does it mention their number or qualifications. The tests conducted appear to be primarily engineering and safety compliance tests rather than clinical studies requiring expert ground truth for interpretation of ECG data.

4. Adjudication Method for the Test Set

Since there's no mention of experts establishing a ground truth or interpreting data, there's no information about an adjudication method.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as acquiring, recording, and transmitting ECG signals for review by a physician, but there's no study presented that evaluates the performance of human readers with or without AI assistance, or an effect size. The "Analysis module" for the device provides ECG measurements but "does not make any interpretation."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document describes the device's "Analysis module" which "provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, QRS duration, etc." This indicates that the device itself performs some algorithmic processing (measurement) but does not provide diagnostic interpretation. Therefore, a standalone diagnostic performance study (algorithm only) as typically understood for AI-based diagnostic devices, is not described here. The presented studies focus on safety, electrical performance, and software validation.

7. Type of Ground Truth Used

Given the nature of the tests (compliance with standards like IEC 60601-1-12, software validation), the "ground truth" would be defined by the technical specifications of the standards themselves (e.g., passing specific electrical tests, proper software function as per design documents) rather than expert consensus, pathology, or outcomes data related to ECG interpretation. The document does not describe studies requiring such clinical ground truth.

8. Sample Size for the Training Set

The document does not mention a training set sample size. Since the device's "Analysis module" provides measurements but no interpretation, it's unlikely to involve machine learning models that require extensive training data in the traditional sense for diagnostic capabilities. The software validation tests mentioned ("Unit Test, Integration Test, System Test") are for functional correctness rather than training predictive models.

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

As no training set is described, there is no information on how ground truth for a training set was established.

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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 infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as 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 OT ECG system is a non-defibrillator-proof, hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The OT ECG system consists of 5 major components:

• ·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, then send the recorded data via cloud to a certified medical professional for review.
• . Analysis - The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, ORS duration, etc.
• . 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 QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is intended for use on infants, children and adults 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.

The provided text is a 510(k) Summary for the QT Medical, Inc. QT ECG device (K220795). This document primarily focuses on establishing substantial equivalence to a predicate device (K180157) and outlines various non-clinical testing performed to show safety and performance. However, it does not contain the detailed clinical study information typically required to describe acceptance criteria and the study that proves the device meets those criteria for an AI/ML enabled medical device.

The document states:

• "All the test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria and indication for use, and is substantially equivalent to the predicate device." (Page 5)
• "Although there are some different specifications between two devices, the software validation, performance test and usability test have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has also undergone all safety and performance tests, and the results complied with the test requests." (Page 14)

These statements indicate that acceptance criteria exist and were met through testing. However, the document lists these tests as "Non-clinical Testing" including biocompatibility, software validation, cybersecurity, electromagnetic compatibility, electrical safety, performance (of electrode and recorder, durability, wireless interference), and human factors (usability). These are engineering and regulatory compliance tests, not a clinical study proving diagnostic or predictive performance against specific clinical acceptance criteria for an AI/ML algorithm's output.

The device description on page 5 explicitly mentions:

• "Analysis - The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, QRS duration, etc."
• "The QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function." (Page 5)

This indicates that the "Analysis module" performs basic ECG measurements (e.g., intervals, durations) but does not provide diagnostic interpretations or AI-driven insights that would require validation through a clinical study with expert ground truth. The device's function is data acquisition and transmission, not automated diagnosis or interpretation. Therefore, a clinical study of the device's diagnostic performance, as might be done for an AI/ML device that provides interpretations, is not described because it appears not to be within the scope of this device's intended use or capabilities.

Given the information provided in the document, I cannot create the requested table or answer most of the questions because the device does not include an AI/ML component for diagnostic interpretation and the detailed clinical study information is not present. The "performance test" mentioned in the non-clinical testing section likely refers to technical specifications for ECG signal acquisition and transmission, not clinical outcome or interpretative accuracy.

Therefore, the following table and answers are based on the absence of such information in the provided document, reflecting that this device's clearance did not hinge on an AI/ML diagnostic performance study.

Acceptance Criteria and Device Performance (Based on available information)

The provided submission does not detail acceptance criteria related to AI/ML diagnostic performance as the device's "Analysis module" performs raw ECG measurement without interpretation or diagnostic capabilities. The acceptance criteria mentioned are general for device functionality, safety, and substantial equivalence to a predicate device.

Answers to Specific Questions (Based on available information):

1. A table of acceptance criteria and the reported device performance:
   (See table above. Note: This device is not described as having an AI/ML diagnostic component, so the clinical performance criteria typically associated with such devices are not present.)

2. Sample sizes used for the test set and the data provenance:
   The document mentions general "validation activities" and "performance tests" but does not specify sample sizes for test sets related to clinical performance or diagnostic accuracy. The data provenance (e.g., country of origin, retrospective/prospective) for any specific performance testing is also not provided. The testing described appears to be primarily engineering and regulatory compliance testing rather than clinical study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   Not applicable/Not provided. Since the device states it "does not make any interpretation" and "does not have diagnostic alarm function," there's no indication that expert-established ground truth for diagnostic or interpretative performance was required or used in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable/Not provided. No clinical diagnostic test set or adjudication method is described in this 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:
   No MRMC study was done or described. The device does not appear to provide AI assistance for human interpretation, as its analysis module only provides measurements, not interpretations.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No standalone diagnostic performance study was done or described as the device's analysis module explicitly states it "does not make any interpretation."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable/Not provided regarding diagnostic ground truth, for reasons stated above. The ground truth for the non-clinical performance tests would be defined by engineering standards and specifications.

8. The sample size for the training set:
   Not applicable/Not provided. As the device's "Analysis module" performs measurements rather than AI-driven interpretations, there's no mention of a training set for a machine learning algorithm.

9. How the ground truth for the training set was established:
   Not applicable/Not provided. (See answer to question 8).

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PCA-C100 Patient Cable is intended to be used with QT ECG device. The Patient Cable is used to connect electrodes placed at appropriate sites on the patient to an ECG device for general diagnostic evaluation by healthcare professionals.

The PCA-C100 Patient Cable is a reusable ECG patient cable that is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the patient's body for both diagnostic purposes. The PCA-C100 Patient Cable is a crucial part of the system used diagnose the cardiac electrical signal (ECG). It allows a safe connection between the electrodes on the patient and QT ECG (K180157). The PCA-C100 Patient Cable is composed of three components: Snap - Connected with Leadwire and commercial ECG electrode. Leadwire - fitted with Trunk, and connected with ten Snaps. Trunk - Fitted with two ends: one of them connects the QT ECG (K180157); and the other end connects the Leadwires.

The document provided is a 510(k) Summary for the PCA-C100 Patient Cable, which is a medical device for transmitting cardiac electrical signals. This type of device is relatively simple and does not involve AI or complex diagnostic algorithms, so many of the requested criteria (like ground truth, expert consensus, MRMC studies, or training/test set details) are not applicable.

Based on the provided information, here's a summary of the acceptance criteria and the study proving the device meets those criteria:

Device: PCA-C100 Patient Cable
Intended Use: To connect electrodes placed at appropriate sites on the patient to an ECG device (specifically QT ECG device, K180157) for general diagnostic evaluation by healthcare professionals.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with recognized medical device standards for electrical safety, biocompatibility, and performance for patient cables. The reported device performance indicates successful compliance with these standards.

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

The document does not specify a "test set" in the context of diagnostic performance evaluation with a dataset of patient cases because this device is a patient cable, not a diagnostic algorithm.

• Sample Size: The testing was conducted on physical samples of the PCA-C100 Patient Cable. The exact number of samples used for each test (biocompatibility, electrical safety, performance) is not specified in this summary document.
• Data Provenance: Not applicable in the context of patient data for a diagnostic algorithm. The tests were performed in a laboratory setting on the device itself.

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

Not applicable. This device is a passive patient cable, not a diagnostic algorithm that requires expert interpretation for establishing ground truth on patient data. Ground truth, in this context, refers to the verifiable correctness of the device's physical and electrical properties against established standards.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or AI output review, which is not relevant for a patient cable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging or analytical devices where human readers interpret results, sometimes with and without AI assistance, to assess diagnostic accuracy or efficiency. This is not applicable to a patient cable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a patient cable, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by objective measurements and assessments against recognized industry standards and scientific principles during non-clinical (bench) testing. For example:

• Biocompatibility: In-vitro and in-vivo tests to determine the material's interaction with biological systems according to ISO 10993 standards.
• Electrical Safety: Measurements of electrical parameters (e.g., leakage current, impedance) compared against limits specified in IEC 60601-1 and ANSI AAMI EC53.
• Performance: Functional testing to ensure proper signal transmission and mechanical integrity according to ANSI AAMI EC53.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware component and does not utilize machine learning or AI, therefore it does not have a "training set."

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

Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.

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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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