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QUEST is designed to provide ECG information and data to qualified medical personnel for the purpose of assessing the patient's cardiac response to exercise. It is to be used in hospitals, clinics, or physician offices by a qualified and licensed physician, or by trained staff under the direct supervision of that physician.

Stress-test or exercise electrocardiography is used a) when the diagnosis of coronary artery disease is suspected, b) to determine the physical performance characteristics of a patient, c) for post myocardial infarction assessment, or d) for cardiac rehabilitation. The test involves the recording of the electrocardiogram during dynamic or, occasionally, isometric exercise. Disease assessment is most prominent in adult patients. The diagnostic value of exercise testing primarily concerns either ST segment depression present in myocardial ischemia, or elevation seen in infarcts (in comparison to P-Q segment as the isoelectric line). In addition, it is important to consider the patient's blood pressure response and physical symptoms.

This instrument is not intended to interpret any exercise test results but is to be used as an aid for the physician to determine normal or abnormal response of the patient to exercise.

QUEST is not intended for long term monitoring of patient ECG signals. Specifically, it does not substitute for recommended cardiac monitoring devices recognized by AAMI EC13, especially in the area of alarms.

This instrument (OUEST) provides a method of collecting a multichannel ECG for dynamic evaluation of exercise performed by the patient. In order to provoke myocardial ischemia, the degree of stress must be sufficient to exceed the critical level of the patient's myocardial oxygen demand. The specificity of ST changes in identification of ischemia increases with the degree , time of onset, and when more than one electrocardiograph lead exhibits the abnormality. These patients can walk on a treadmill in which the speed and elevation can be adjusted (automatically or manually) to suit a variety of graded exercise protocols, or pedal an electronically braked bicycle ergometer. If the test subject is unable to walk, isometric exercise can be performed using a handheld dynamometer, or injecting the patient with heart rate stimulants to stress the myocardial system and then use this instrument's monitoring capability. It is operated from a standing position with design consideration given to ergonomic heights, viewing access of the information display, and control functions. It is cart based, with wheels, to provide easy movement. It can be used in conjunction with echocardiography, nuclear imaging, or pulmonary gas exchange equipment by providing ECG trigger signals and/or treadmill speed and grade levels.

This instrument can also serve as an adult resting interpretive electrocardiograph with the addition of Burdick's resting interpretive program.

The OUEST with T-Wave Alternans Option is intended for the measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.

The presence of Microvolt T-Wave Alternans as measured by the QUEST with T-Wave Alternans Option in patients with known or suspected ventricular tachyarrhythmia, or who are at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The OUEST with T-Wave Alternans Option should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Report Classifier software should be reviewed by a qualified physician.

The predictive value of T-Wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

*Microvolt T-Wave Alternans is defined as T-wave alternans which a) is measured from high-resolution multi-segment sensors, b) is present in leads X, Y, Z, VM, or two adjacent precordial leads, c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, d) is at least three standard deviations greater than the background noise level, e) has an onset heart rate of below 110 beats per minute, and f) is sustained for all heart rates above the onset heart rate.

The Quest Exercise Stress System is a computer based electrocardiograph (ECG) exercise stress test system designed for use with both treadmill and bicvcle eraometer exercise protocols. The Quest Exercise stress system provides real time ECG waveforms and calculations to qualified medical personnel while providing automatic or manual control of the exercise equipment.

The Quest Exercise Stress System with T-wave alternans option provides measurement of T-wave alternans measurement in addition to the functions of the ECG. The Alternans Report Classifier software used with the Twave alternans option provides a preliminary assessment of the alternans report data.

The provided text is a 510(k) summary for the Spacelabs Burdick Quest Exercise Stress System with the addition of Cambridge Heart's Alternans Report Classifier software. It describes the device, its indications for use, and specifications, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification (510(k)) to the FDA, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance validation studies with specific acceptance criteria and outcome metrics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance details, training set sample size, or how ground truth for training was established.

The document states: "Quest with the addition of the Alternans Report Classifier software is substantially equivalent to the currently marketed QUEST system." This is the core "proof" presented in a 510(k) submission: that the new device (or modification) is as safe and effective as a legally marketed predicate device. The specifications listed are descriptive, not performance targets with associated test results.

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Quest is designed to provide ECG information and data to qualified medical personnel for the purpose of assessing the patient's cardiac response to exercise. It is to be used in hospitals, clinics, or physician offices by a qualified and licensed physician, or by trained staff under the direct supervision of that physician.

Stress-test or exercise electrocardiography is used a) when the diagnosis of coronary artery disease is suspected, b) to determine the physical performance characteristics of a patient, c) for post myocardial infarction assessment, or d) for cardiac rehabilitation. The test involves the recording of the electrocardiogram during dynamic or, occasionally, isometric exercise. The diagnostic value of exercise testing primarily concerns either ST segment depression present in myocardial ischemia, or elevation seen in infarcts (in comparison to P-Q segment as the isoelectic line). In addition it is important to consider the patient's blood pressure response and physical symptoms. Disease assessment is most prominent in, but not limited to, adult patients.

This instrument can also serve as an adult resting interpretive electrocardiograph with the addition of Burdick's resting interpretive program.

This instrument is not intended to interpret any exercise test results but is to be used as an aid for the physician to determine normal or abnormal response of the patient to exercise.

Quest is not intended for long term monitoring of patient ECG signals. Specifically it does not substitute Quest is not intended for folly will and ices recognized by AAMI EC13 especially in the area of alarms.

This instrument (QUEST ) is a computerized exercise stress testing system which provides a method for dynamic exercise evaluation performed by the patient who walks on a treadmill in which the speed and elevation can be adjusted (automatically or manually) to suit a variety of graded exercise protocols, or when the patient pedals an electronically braked bicycle ergometer. If the test subject is unable to walk, isometric exercise can be performed using a handheld dynamometer, or by injecting the patient with heart rate stimulants to stress the myocardial system. In each case this instrument is used to present real-time ECG waveforms and calculations to qualified medical personnel while providing automatic or manual control of the exercise equipment. Paper reports are commonly produced.

It contains a viewing screen of sufficient size to accommodate easy reading of important patient and test parameters such as heart rate, test time, ECG waveforms and ST indications. To minimize distractions to the operators and patients during tests, no alarms are used and user-defined prompting encourages timely entry and recording of important test data (such as blood pressure).

Paper test records can be obtained from the thermal recording system incorporated into the design. Formats for the test summaries and data obtained during the test are selectable, enhancing its usage for a variety of test facilities. The ability to produce print records of ECG waveforms during exercise and recovery are continuously made available to the users.

Processing of the incoming ECG signal from the (10) electrode sites results in a real time display, heart rate determination, ST measurement indices and values, ectopic beat detection, pacemaker detection, and optionally, interpretation of the resting ECG signals. Further calculations support exercise such as METS, target heart rate, calories, distance, and protocol timers.

Interfaces are provided to enable connection to Burdick's T600 treadmill, an Ergomed 840 Bike ergometer, standard electronically braked bike ergometers, non-invasive blood pressure equipment, oximetry devices supporting serial communications protocols, and computer communications equipment such as printers, fax/modems and networks. The measurement devices typically return a value to be displayed on-screen and Quest is not involved in making the actual measurements. In addition, analog outputs provide a selection of ECG signals, ergometer speed and grades, and exercise data (heart rate, workload, etc.). A digital QRS pulse output is available as a trigger typically used for echocardiography, nuclear imaging equipment, or pulmonary gas exchange equipment.

The computer system is based on an industry standard computer chip and uses a standard software operating system. Custom circuits are fabricated by Burdick and integrated with standard assemblies purchased from outside suppliers

The provided text is a 510(k) summary for the Burdick Quest Exercise Stress System, which focuses on demonstrating substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

Specifically, the document:

• Describes the device's function and intended use.
• Compares its functionalities and technical specifications to predicate devices (Quinton Q4500 Stress Test System and Burdick E350i Electrocardiograph) to establish substantial equivalence.
• Mentions compliance with the AAMI Standard for Diagnostic Electrocardiographs for ECG acquisition parameters (Leads acquired, Frequency response, Input impedance, Patient isolation, Sensitivity). This is the closest it comes to "acceptance criteria," but it lists the type of specification, not the actual numerical criteria or performance results proving compliance.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is primarily a regulatory filing to show equivalence, not a performance study report with detailed acceptance criteria and validation results.

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