(28 days)
To analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to overread and validate (or change) the computer generated ECG interpretation.
Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.
Based on ECG signals acquired from ten electrodes (12 leads), the 12-lead analysis algorithm monitors signal quality, measures waveform components and recognizes patterns, and performs basic rhythm analysis. Using the extended measurements and patient-specific information, the algorithm generates those interpretive statements from the criteria program that summarize the findings for the ECG and highlight key areas of concern for physician review.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets these criteria. The document is a 510(k) summary for the Philips 12-Lead Algorithm, outlining its substantial equivalence to a predicate device, its indications for use, and regulatory information.
Specifically, the text states:
- "Verification, validation, and testing activities establish the performance and functionality characteristics of the new device. Testing involved system level tests, integration tests and regression tests from hazard analysis. Pass/Fail criteria were based on the specifications and test results showed substantial equivalence. The results demonstrate that the functionality of the modified Philips 12-Lead Algorithm meets all performance claims." (Page 1, Item 7)
However, this statement provides a high-level overview without detailing the specific acceptance criteria, the reported device performance against those criteria, or the methodology of the study. It also doesn't include information about sample sizes, data provenance, expert qualifications, or other specific study design elements requested in the prompt.
Therefore,Based on the provided text, I cannot extract the detailed information requested in the prompt. The document is a 510(k) summary focusing on substantial equivalence, and it mentions that "Pass/Fail criteria were based on the specifications and test results showed substantial equivalence," but it does not specify what those criteria were or the detailed results of the study.
§ 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).