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The Heartlab HeartStation™ ECG Management System is a comprehensive data management solution which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.

The Ascentia HeartStation™ ECG Management System ("HeartStation™") is a comprehensive data management solution, which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.

HeartStation™ allows access to ECG records from web-enabled PCs throughout a network. Authorized clinical users may also access HeartStation™ from remote locations, including a home office. The type of access that is permitted depends on the clinical user within the healthcare enterprise, and can include the ability to produce confirmed, signed diagnostic reports

Comprehensive workflow management software enables HeartStation™ to be tailored to the needs of the enterprise, resulting in the highest possible level of automation for routine tasks. The processing of an ECG can be adjusted depending on a patient's stage within the care process, from an emergency event to a routine follow-up test. Final ECG reports are distributed by printing, faxing, e-mailing and automatic exporting to other systems, including an electronic medical record.

A patient's confirmed ECGs become a part of his or her cardiology information and image record within the Heartlab Ascentia™ database. Authorized clinicians may review patients' integrated ECG, X-ray Angiography, Echocardiography and other cardiology tests through a web-enabled Ascentia PortalTM.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria. It is a 510(k) summary for the Heartlab Ascentia HeartStation™ ECG Management System, outlining its description, intended use, substantial equivalence to predicate devices, and regulatory compliance.

Specifically, it includes:

• Identification of the product: Ascentia HeartStation™ ECG Management System.
• Device Description / Intended Use: Automates processing, storage, and display of ECGs, normalizes 12-lead ECGs, measures, interprets, performs serial comparisons, stores with preliminary diagnoses, allows physician review and modification, electronic signature, and distribution of reports.
• Substantial Equivalence Information: Compares the device to several predicate devices (Dräger-Siemens Infinity MegaCare, Burdick Eclipse ECG, Philips Tracemaster ECG Management System, Quinton Pyramis ECG Management System), highlighting similarities in function, user interface, operating systems, record export, web software, and the use of the Glasgow Interpretive ECG Program or Philips 12-lead algorithm for measurement.
• Standards: Lists various safety and performance standards the device is designed to meet.
• Summary of Design Control Activities: Describes the quality assurance design control measures applied during development, including risk analysis, requirement reviews, design reviews, and various levels of testing.
• FDA 510(k) Clearance Letter: Confirms the substantial equivalence of the device to legally marketed predicate devices.
• Indications for Use: Reiteration of the device's function as a comprehensive ECG data management solution.

The document does not provide:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Information on experts used for ground truth or their qualifications.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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