(165 days)
IQmark EZ Stress is intended to be used under the supervision of a physician, in hospitals, clinics and physician's office, to acquire, display, process, record, analyze and print the patient's electrocardiograms from the human body surface during stress induced from exercise devices such as a treadmill, a bicycle ergometer or drug induced (pharmacological) stress.
The device may provide interfaces with external devices, such as a treadmill or an ergometer, non-invasive blood pressure equipment, and computer communication equipment.
The device is not intended to be used as a vital signs physiological monitor.
The IQmark EZ Stress test system is a computer-based diagnostic electrocardiograph that is designed for exercise stress test. The IQmark stress runs on the Microsoft Windows environments and can control a treadmill or an ergometer through a serial port. The IQmark EZ Stress provides real time ECG data acquisition, waveform display, and ORS detection. It calculates the heart rate, detects ventricular ectopic beats, generates the average beats, measures the ST segment levels and slopes, generates the test reports, and stores the reports in the database. The IQmark EZ Stress system also provides reports and FCG strip printing and review and editing capabilities for trained personnel to manage the patient`s report.
Here's an analysis of the acceptance criteria and study information based on the provided text for the IQmark EZ Stress device:
Acceptance Criteria and Study Details for IQmark EZ Stress
This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing novel performance metrics. Therefore, the "acceptance criteria" for the IQmark EZ Stress are largely defined by its ability to meet the same technical specifications and features as the predicate devices and conform to relevant industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission focuses on substantial equivalence, the "acceptance criteria" are implied by the comparison to predicate devices and adherence to standards. The "reported device performance" is described as meeting these criteria.
| Acceptance Criteria (Implied by Predicate Comparison & Standards) | Reported Device Performance (IQmark EZ Stress) |
|---|---|
| Functional Equivalence to Predicate Devices: | The IQmark EZ Stress has many identical or similar technical specifications and features to the two predicate devices (Q-Stress and CASE 8000), including operating system, ECG lead capacity, signal processing capabilities, QRS detection, ST segment measurements, editing, and report generation. |
| Technical Specifications (e.g., ECG analysis frequency, frequency response, filters) equivalent to predicate devices. | - ECG analysis frequency: 500Hz |
- ECG frequency response (-3 dB): 0.05-150Hz
- High pass filter: 0.05Hz
- Low pass filter: 40, 150Hz
- Line Filter: 50, 60Hz
(Matches or is comparable to predicate devices where specified). |
| Conformance to AAMI/ANSI EC11: 1991 (ECG hardware). | ECG hardware is designed in conformance with AAMI/ANSI EC11: 1991. |
| Meeting EMC requirements of EN60601-1-2:2001. | ECG hardware meets the EMC requirements of EN60601-1-2:2001. |
| Performance of Heart Rate Calculation and ST Segment Measurements according to AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998. | Performance of heart rate calculation and ST segment measurements tested according to appropriate sections of AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998. |
| Software meets design specifications and user-level requirements. | Software Verification Procedure executed to confirm correct implementation of design. Software Validation Procedure executed to challenge completeness and correctness of user-level requirements. |
| Implementation of risk reduction activities identified in System Risk Analysis. | Traceability Analysis demonstrated implementation of prescribed risk reduction activities. |
| Safe and Effective as predicate devices. | Test results demonstrated the device is as safe and effective as the two predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a distinct "test set" with a particular sample size for external clinical data. Instead, the validation primarily relies on:
- Internal Verification & Validation Tests: These were performed for the "entire development effort" and for "user level requirements" but no specific case numbers are provided.
- Beta Tests: The device underwent "beta tests in a physician's office." No sample size or data provenance (e.g., country of origin, retrospective/prospective) for these beta tests is explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The document does not describe the establishment of a "ground truth" by experts for an external test set in the conventional sense of a clinical study. The validation relies on internal testing against design specifications, compliance with industry standards, and comparison to predicate devices, implying that the "ground truth" for these tests would be the expected output based on these specifications and standards.
4. Adjudication Method for the Test Set
Not applicable. No external test set requiring expert adjudication is described in the provided text.
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 comparative effectiveness study is mentioned. This device is a stress test system, not an AI-powered diagnostic reader, so such a study would not be directly applicable in the context of human reader improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, aspects of algorithm-only performance were tested:
- The QRS detection, heart rate calculation, and ST segment measurement algorithms (derived from Brentwood's ST and Arrhythmia Analysis library) were tested according to the appropriate sections of AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998. These are industry standards for ambulatory electrocardiographs and stress monitors, implying a standalone performance evaluation against defined criteria.
7. The Type of Ground Truth Used
The "ground truth" for the various tests mentioned appears to be:
- Industry Standards: For QRS detection, heart rate, and ST segment measurements (AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998). These standards define expected performance characteristics and often include reference data or methods for assessing accuracy.
- Design Specifications: For the general software functionality and user-level requirements, the ground truth would be the documented design specifications and requirements.
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical device (stress test system) whose algorithms are derived from an existing library (Brentwood's ST and Arrhythmia Analysis library, K013717). It does not mention machine learning or AI models requiring a "training set" in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is mentioned.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).