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The TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records.

The TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records. TraceMaster communicates with Webbased clients, faxes, printers etc through a client/server industry-standard network with other hospital information systems.

The provided text describes the Philips M5100A/M5101A TraceMaster ECG Management System and its 510(k) submission. However, it does not contain specific acceptance criteria, detailed performance metrics, or a formal study report with the information requested in the prompt. The document primarily focuses on establishing substantial equivalence to a predicate device.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The general statement "system level tests, integration tests and regression tests" does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. This type of device (ECG management system for viewing, editing, printing, archiving) doesn't typically require a "ground truth" derived from expert consensus in the same way an AI diagnostic device would. Its performance is more about accurate data handling and display.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device, formal adjudication by multiple experts is unlikely to be relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. An MRMC study is not typically relevant for an ECG management system whose primary function is data handling and display, rather than automated interpretation or diagnosis where human performance enhancement would be measured.

6. Standalone (Algorithm Only) Performance Study

This information is not provided in the document. The TraceMaster is a "computer system which allows viewing, manual editing, printing, and archiving," implying a human-in-the-loop for interpretations and editing. It is not an algorithm performing a standalone diagnostic function.

7. Type of Ground Truth Used

Based on the device's function, the "ground truth" would be the accurate representation and storage of digitized ECG records, consistent with the source data. This is established through verification and validation of the system's functions against design specifications. Specific methods (e.g., pathology, outcomes data) are not applicable for this type of system.

8. Sample Size for the Training Set

This information is not provided in the document. The device is described as a "computer system," not an AI/ML algorithm that requires a training set in the conventional sense. Its development would involve software engineering and testing against functional requirements.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable as the device is not described as an AI/ML system requiring a "training set" with ground truth in the context of machine learning.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document 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 ECG Management System meets all performance claims."

This describes a general software testing approach focused on functionality, system integration, and regression testing against known hazards. It emphasizes "substantial equivalence" to a predicate device (M1730B/M3700A TraceMaster ECG Management System cleared under K974420) as the primary basis for regulatory clearance, rather than a detailed performance study with specific acceptance criteria as might be expected for novel diagnostic algorithms.

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