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510(k) Data Aggregation
(406 days)
Dr.LEE ECG-310A (with interpretive software) is to be used to process the electrical signal transmitted through electrodes and to produce a visual display of the electrical signal produced by the heart. While the Dr.LEE ECG-310A is capable of interpreting the ECG waveform as an aid, it is not intended to replace the review and interpretation by the physician. To be used under professional healthcare supervision.
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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Dr. Lee ECG-310A, which confirms its substantial equivalence to a predicate device. It specifies the intended use and regulatory classification but does not include specifics about performance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.
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(243 days)
Dr. LEE ECG-110B, 120B and 310B (non-interpretive electrocardiographs) is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signal produced by the heart.
The patient population is any patient requiring an electrocardiograph at the direction of a physician.
The product is to be used in a medical professional environment, such as a doctors office, hospital, medical clinic and the like.
non-interpretive electrocardiographs
This document is a 510(k) premarket notification letter from the FDA to Dr. Lee Co., Ltd. for Electrocardiographs Models 110B, 120B, and 310B. It states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria, detailed device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It focuses on the regulatory approval process and indications for use.
Therefore, I cannot provide the requested information based on the provided text.
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