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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 over read and validate (or change) the computer generated ECG interpretation.

The TC series of cardiographs all provide the same basic functionality and utilize the same software code to provide different features. For example the TC 70 cardiograph has a digital patient interface module, the largest display, has the complete set of clinical features and the latest ECG data management capabilities.

The TC 20 cardiograph is the newest addition to the TC family of cardiographs. It provides the following basic feature set for diagnostic cardiographs: 12 lead ECG acquisition and analysis, rhythm printing of ECG, 12 lead ECG report, battery and line operated power, ECG storage and LAN / wireless connectivity.

1. Acceptance Criteria and Device Performance:

The provided document describes the Philips PageWriter TC20 Electrocardiograph and its substantial equivalence to the predicate device, PageWriter TC30. It does not present specific numerical acceptance criteria for a clinical study comparing an AI algorithm's performance against a human or a predefined benchmark. Instead, it focuses on demonstrating that the TC20, including its ECG circuit and embedded algorithm, meets safety and effectiveness standards by comparing its technological characteristics to a legally marketed predicate device (TC30) and complying with recognized FDA standards.

Therefore, there is no direct table of acceptance criteria and reported device performance in the context of an AI algorithm's diagnostic accuracy. The key "acceptance criteria" here are:

• Technological equivalence to the predicate device.
• Compliance with recognized FDA standards for medical electrical equipment and electrocardiographic devices.

Table of Acceptance Criteria and Device Performance (in terms of substantial equivalence):

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

The document states, "The PageWriter TC20 cardiograph is not required to do clinical test for determination of substantial equivalence. The ECG 12 lead algorithm used for interpretive statements was cleared in a previous 510(K) submittal."

This implies that no new clinical (test set) study was performed for this specific 510(k) submission (K113144) to evaluate the diagnostic accuracy of the ECG interpretation algorithm with new data. The focus was on demonstrating hardware and software equivalence to an already cleared device and adherence to recognized standards. Therefore, information regarding sample size, data provenance, and ground truth establishment for a new test set is not provided here.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not applicable for this 510(k) since no new clinical study (test set evaluation) for the algorithm's diagnostic performance was conducted as part of this submission. The algorithm itself was previously cleared.

4. Adjudication Method for the Test Set:

Not applicable for this 510(k) as no new clinical test set evaluation for diagnostic performance was performed.

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

No MRMC study was performed or referenced as part of this 510(k) submission for the PageWriter TC20. The submission relies on substantial equivalence to a predicate device and compliance with standards, not on demonstrating improved human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study:

A standalone study for the interpretive statements (algorithm) was performed historically, as it states, "The ECG 12 lead algorithm used for interpretive statements was cleared in a previous 510(K) submittal." However, the details of that previous standalone study (e.g., specific metrics, dataset size, ground truth methodology) are not provided in this document. This 510(k) focused on the device (PageWriter TC20) incorporating an already cleared algorithm.

7. Type of Ground Truth Used (for the Algorithm's previous clearance):

The document does not explicitly state the type of ground truth used for the previously cleared ECG 12-lead algorithm. Typically, for ECG interpretation algorithms, ground truth involves expert consensus by cardiologists, sometimes supported by clinical outcomes or invasive procedures for specific diagnoses.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for training the ECG 12-lead algorithm, as this algorithm was previously cleared.

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

The document does not provide information on how the ground truth for the training set of the ECG 12-lead algorithm was established, as this algorithm was previously cleared under a different submission.

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