(44 days)
The Philips ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The cardiac data provided by the Stress system is intended to be reviewed, confirmed, and used by trained medical personnel to assist in the evaluation of the patient's cardiovascular condition and the patient's physiological condition during stress exercise testing. The arrhythmia detection portion of the ST80i Stress Exercise System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.
The Philips ST80i Stress Test System is indicated for use in exercise ECG testing where the clinician decides to evaluate the electrocardiogram of patients at 10 years or older, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms of cardiovascular disease. The Philips ST80i Stress Test System is not intended to be used as a physiological monitor.
The ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data (resting and physiologic) of patients undergoing stress exercise testing and acquire data from ancillary devices (such as SpO2 and Ambulatory Blood Pressure). The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The arrhythmia detection portion of ST80i Stress Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The cardiac data provided by the stress system is intended to be reviewed, confirmed and used for diagnostic purposes by trained medical personnel to assist in the diagnosis of coronary artery disease (CAD) and the patient's physiological condition during stress exercise testing. The ST80i Stress Test System will be offered in two versions which are a complete turnkey system which includes an ECG data acquisition module, trolley with a PC loaded with the application software and optional thermal printer or a minimal system with the application software and data acquisition module only.
The Philips ST80i Stress Test System is a PC-based diagnostic tool designed to acquire, process, and store ECG data during stress exercise testing. It records ECG, heart rate, and ST data, generates summary tables, trends, and reports for cardiac data indices. The system's arrhythmia detection offers convenience but does not provide alarms. It is intended to assist trained medical personnel in evaluating cardiovascular conditions, diagnosing coronary artery disease (CAD), and assessing physiological conditions during stress exercise testing for patients 10 years or older. It is not intended as a physiological monitor.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ST80i Stress Test System are largely demonstrated through its equivalence to the predicate devices, CASE V6.6 and CS V6.6 Cardiac Testing Systems. The provided documentation presents a comparison of specifications and features rather than explicit acceptance criteria with numerical targets. The "Comparison" column indicates whether the ST80i's performance is "Same," "Similar," or "Different" to the predicate.
| Specification/Feature | ST80i Stress Test System Reported Performance | Predicate Device (CASE V6.6 and CS V6.6 Cardiac Testing Systems) | Comparison (Acceptance Status) |
|---|---|---|---|
| Indications for Use | PC-based diagnostic tool for acquiring, processing, storing ECG data during stress exercise testing. Assists in CAD diagnosis and cardiovascular condition evaluation by trained medical personnel. Arrhythmia detection for convenience, no alarms. | Similar intended use, operating environment, and diagnostic assistance features. Does not offer diagnostic opinion. | Similar |
| Healthcare Facilities | Used in hospital or facilities providing exercise & stress testing, ECG, spirometry, ABP testing. | Similar | Similar |
| Sampling Rate | 1000 samples per second | 500 samples per second | Different |
| Bandwidth | 0.050 - 150 Hz | 0.050 - 150 Hz | Same |
| Input Signal Resolution | 5µV/LSB at 1000 Hz | 4.88µV/LSB at 500 Hz | Similar |
| Notch Filter | Yes, configurable | Yes, Configurable | Same |
| Baseline Correction | Cubic Spline Algorithm | Cubic Spline Algorithm | Same |
| Artifact/Baseline Correction | No (did not implement FRF due to potential distortion) | Finite Residual Filter (FRF) Analysis | Different |
| ST Measurements | ST amplitude, ST Slope, index, ST/HR index | ST amplitude, ST Slope, integral, index, ST/HR slope, ST/HR loops, ST/HR index up to 15 leads | Similar |
| Heart Rate | Automatic Arrhythmia detection, documentation and annotation | Automatic Arrhythmia detection, documentation and annotation | Same |
| QRS detection and selection | Configurable | Configurable | Same |
| Full-disclosure | Automatic or manual lead selection | Automatic or manual lead selection | Same |
| Real-time ECG/TTL output | Real-time ECG/TTL or analog synchronization output | Real-time ECG/QRS beep/TTL synchronization output | Similar |
| Beat-to-beat ECG storage | Beat-to-beat ECG storage and event review | Beat-to-beat ECG storage and event review | Same |
| Post J-Point measurements | Post-test medians measurements from J point selections | Post-test medians measurements from E, J and post-J point selections | Similar |
| ECG interpretation | Philips ECG Algorithm (resting) (for adults and pediatrics) | (Optional) Marquette 12SL resting ECG analysis program for adults | Similar |
| Dynamic Range | 300 mV | 320 mV ± 10 mV signal superimposed on ± 150mV DC offset | Similar |
| Noise | 118dB (110dB with AC filter disabled) | >140 dB (123 dB with AC filter disabled) | Similar |
| Input Impedance | >=2.5M ohms @ 10Hz | >10 M Ohms @10 Hz, defibrillator protected | Similar |
| Patient Leakage |
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).