(51 days)
To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. To be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished 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.
The M5000A Series Cardiograph is Philips Medical Systems' cardiograph offering a full complement of features, for both adult and pediatric patients.
The Cardiograph offers increased speed and ease-of-use for patient data entry. The device also consists of a digital patient acquisition module, LCD display and rechargeable battery, thermal printer, optional barcode scanner or magnetic card strip reader.
The Cardiograph provides crisp, easy-to-read ECGs on a standard page. Records are clearly labeled with ECG data and patient information.
This document (K020708) is a 510(k) Summary of Safety and Effectiveness for the Philips Medical Systems M5000A Series Cardiograph. It does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states:
- "Prior to marketing in the US, M5000A will have completed the testing listed above with acceptable results, demonstrating substantial equivalence." (Section 10)
- "The substantial equivalence of the M5000A Series Cardiograph is demonstrated by the following non-clinical testing: Testing to applicable standards: AAMI EC11, IEC 60601-1, UL 2601.1, IEC 60601-2-25, IEC 60601-1-2. The performance, functionality, and reliability characteristics of the device and algorithm software testing follow established test procedures and quality system." (Section 9)
This indicates that while testing was planned and results were expected to be acceptable, the document itself does not report the specific acceptance criteria or the detailed results of a study that proves the device meets them. It also does not discuss AI assistance, ground truth establishment for a training set, or other detailed performance metrics beyond general compliance with standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I provide information related to sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, training set sample size, or how ground truth for the training set was established. This information would typically be found in detailed validation reports, which are not included in this 510(k) summary.
§ 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).