(57 days)
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.