(268 days)
The intended use of ECG301 is to acquire ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.
Electrocardiograph, models: ECG301, is to acquire multi-channel ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The device can gather and record ECG signals of 12 leads simultaneously. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.
Electrocardiograph, models: ECG301, has LCD display with touchscreen and functional buttons. The device can be powered from AC power or through an embedded re-chargeable battery. The device contains built-in thermal dot-matrix recorder for ECG report printing. The Electrocardiograph includes main unit and an AC power cord.
The provided document is a 510(k) premarket notification for an ECG device. It outlines the device's technical characteristics and compares them to a predicate device to demonstrate substantial equivalence. However, it explicitly states in Section 8: "There was no clinical testing performed."
Therefore, I cannot provide the information requested in points 1 through 7, or 9, as no clinical study or performance testing against acceptance criteria was conducted for this specific submission to establish clinical accuracy or improvement with AI assistance. The document focuses on non-clinical tests (safety, EMC, software verification) to demonstrate substantial equivalence to a predicate device.
The requested information regarding acceptance criteria and study data would typically be found in a clinical study report or a different section of a more extensive submission for a device that relies on clinical performance data for clearance.
Here's what I can extract and explain based on the provided document:
8. The sample size for the training set:
Not applicable. The document states, "There was no clinical testing performed." This implies no training set was used for performance validation in a clinical context for this submission. The device, an "Electrocardiograph," as described, does not appear to incorporate AI or machine learning that would typically require a training set for its core functionality of acquiring ECG signals. It explicitly states, "ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements."
9. How the ground truth for the training set was established:
Not applicable, as no training set (for clinical performance evaluation) was used or 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).