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The HeartStart 12 Lead Transfer Station SW provides a diagnostic 12 lead ECG interface between Philips defibrillators and ECG management systems that can process XML formatted ECGs, such as the TraceMasterVue ECG Management system.

The HeartStart 12 Lead Transfer Station also allows viewing, printing, archiving and further distribution of digitized ECG records.

The 12 Lead Transfer Station facilitates transmission of diagnostic 12 Lead ECG reports from Philips Defibrillators to ECG Management systems that recognize and accept digitized ECG records using the Philips published ECG schema. The Philips TraceMasterVue ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records. TraceMasterVue communicates with Web-based clients, faxes, printers etc through an industry-standard client/server network with other hospital information systems.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with the requested metrics. The document is a 510(k) summary and an FDA clearance letter for the Philips HeartStart 12 Lead Transfer Station. It broadly states that "Verification, validation, and testing activities establish the performance and functionality characteristics of the new device" and "test results showed substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or elaborate on the specific study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set information) because these details are not present in the provided text.

The document primarily focuses on:

• Device Identification: Name, classification, and contact information.
• Intended Use: Facilitates transmission of diagnostic 12 Lead ECG reports from Philips Defibrillators to ECG Management systems.
• Substantial Equivalence: Declares the new device is substantially equivalent to the previously cleared M5100A TraceMasterVue ECG Management System (K032103).
• Testing Approach (High-Level): Mentions system-level tests, integration tests, and regression tests from hazard analysis.
• Conclusion: States that "Pass/Fail criteria were based on the specifications and test results showed substantial equivalence. The results demonstrate that the functionality of the modified ECG Management System meets all performance claims."

To obtain the detailed information requested, one would typically need to consult the complete 510(k) submission, including the detailed V&V reports, which are not publicly available in this summary format.

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