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The CASE Cardiac Testing System and CS Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CASE is a turnkey product utilizing the CS software. The CS will be offered as a software only package including o front end for data acquisition.

CASE Cardiac Testing System and CS Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.

The CASE Cardiac Testing System and CS Cardioc Testing System are designed to acquire, process, record, archive, and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time without arrhythmia detection. The arrhythmia detection portion of CASE Cardiac Testing System and CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. CASE Cardiac Testing System and CS Cardiac Testing System provide the control of external devices (typically a treadmill or Ergometer) and communicate with centralized electronic/digital storage system via network. CASE Cardiac Testing System and CS Cardiac Testing System provide a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available.

CASE Cardiac Testing System and CS Cardiac Testing System can be configured in a network environment for multiple CASE stations and CS stations allowing the user to create a central database of patient demographics and collected patient physiological data. CASE Cardiac Testing System and CS Cardiac Testing System are intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.

CASE Cardiac Testing System and CS Cardiac Testing System offer no diagnostic opinion to the user. Instead it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.

CASE Cardiac Testing System and CS Cardiac Testing System are not intended to be used as a transport device or for home use.

CASE Cardiac Testing System and CS Cardiac Testing System are not intended for the use as a vital signs physiological monitor or for intracardiac use.

The CASE Cardiac Testing System and the CS Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CS Cardiac Testing System will be offered as a software only package including a front end for data acquisition. The CASE Cardiac Testing System is a turnkey product utilizing the CS Cardiac Testing software. CASE Cardiac Testing System and the CS Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CASE Cardiac Testing System and the CS Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection. The arrhythmia detection portion of CASE Cardiac Testing System and the CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The CS Cardiac Testing System was formerly named Cardiosoft.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. In fact, it explicitly states:

"The subject of this premarket submission. CASE Cardiac Testing System and the CS Cardiac Testing System did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information from the given text. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on technology, intended use, and non-clinical testing (risk analysis, requirements reviews, design reviews, various levels of software testing). It does not detail specific performance acceptance criteria for the device itself or any clinical studies to validate those criteria.

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The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results.

The results of HEART-Exercise are intended to be used by qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.

HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diagnostic opinion to the user.

The Exercise Test Interpretation (XTI) is restricted to adults (age ≥ 18 years). The measurements apply to adults and children able to accomplish an exercise test.

HEART-Exercise is an algorithm library for exercise testing systems. It is able to process up to 15 lead ECGs with a high noise and artifact level and provides real-time and retrospective computerized analysis of stress test ECGs for evaluation by the user.

The provided documentation does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of performance metrics.

Instead, the document states:

• "The subject of this premarket submission, HEART-Exercise, did not require clinical studies to support substantial equivalence."
• "GE Healthcare considers the HEART-Exercise algorithm library to be as safe, as effective, and performance is substantially equivalent to the predicate device."

This indicates that the submission relies on demonstrating substantial equivalence to a predicate device (CardioSoft/CASE Cardiac Testing System, K031561) rather than presenting a de novo study with specific performance acceptance criteria for the HEART-Exercise device itself.

Therefore, the requested details regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies are not available in the provided text. The document focuses on regulatory compliance and the scientific technology similarity to the predicate device.

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Ask a specific question about this device