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Philips Electrocardiograph Page Writer TC cardiograph (TC20, TC30, TC70) is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, and store these ECG signals for review by the user. It is 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 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.

Philips Electrocardiograph, PageWriter TC cardiograph is a product family intended to acquire, record, display, analyze and store multi-channel ECG signals from adult and pediatric patients through a body surface ECG electrode. It includes PageWriter TC20, PageWriter TC30, PageWriter TC50 and PageWriter TC70. Each device under this product family is integrated with the algorithms to provide measurements, data presentations, graphical presentations and interpretations for review by the clinician on an advisory basis. The interpreted ECG with measurements and interpretive statements are to be used in conjunction with 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.

PageWriter TC cardiograph can be operated on the battery when the AC power cord or AC power connector is not in an operable condition, depending on the model of the cardiograph (TC20 single battery only; TC30/TC50 - either one or two batteries; TC70 - two batteries only). When operating a PageWriter TC cardiograph with one battery or two, only the approved batteries with the same part number can be used.

PageWriter TC cardiograph has various configuration provided for the preference of the user, and can be updated with the compatible options/modules from the corresponding Upgrade Kit for use with all approved accessories and spare parts, including patient data cables, Patient Information Modules (PIM), lead sets, electrodes, print papers and trolleys. None of the accessories and spare parts are provided sterile.

Once configured, PageWriter TC cardiograph can provide integrated connectivity (wired or wireless) with the compatible Philips IntelliSpace ECG Management System, or other third party ECG system. for patient order download and ECG transmission. It also supports integrated connectivity with an ADT Order Update system to manage the patient demographic data, and transmit ECG reports in compliance with DICOM protocol once configured with DICOM option. The cybersecurity on PageWriter TC cardiograph is periodically and proactively improved according to the cybersecurity analysis and the routine device cyber maintenance plan.

This FDA 510(k) summary document focuses on modifications to existing medical devices (Philips PageWriter TC20, TC30, TC50, TC70 electrocardiographs) related to battery management and cybersecurity. It explicitly states that no clinical studies were required or conducted for this submission to demonstrate substantial equivalence. Therefore, some of the requested information cannot be provided as it pertains to clinical performance evaluation.

Based on the provided text, here's an analysis of the acceptance criteria and supporting evidence:

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• No specific "test set" in the context of clinical performance is mentioned. The testing described is primarily for engineering verification and validation (e.g., electrical safety, EMC, software, battery).
• Data provenance (country of origin, retrospective/prospective): Not applicable for the types of engineering tests reported.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The submission does not involve a clinical performance study requiring expert adjudication of ground truth for a test set. The "interpretation" of ECG signals is explicitly stated to be advisory and requires overread/validation by a qualified physician.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The document explicitly states: "This premarket submission did not require clinical studies to demonstrate substantial equivalence." The device includes algorithms for interpretation, but its performance with or without AI assistance for human readers was not evaluated in this submission. The interpretation is explicitly documented as "advisory" and subject to physician overread.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document implies that the algorithms provide "measurements, data presentations, graphical presentations and interpretations for review by the user." However, it does not provide details of a standalone (algorithm-only) performance evaluation. The interpretation is advisory and requires a qualified physician to overread.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for clinical performance. For the engineering tests described, the "ground truth" would be the established standards (e.g., IEC standards for electrical safety), the device's design specifications for functionality, and cybersecurity threat models.

8. The sample size for the training set

• Not applicable. This submission focuses on modifications to existing devices, primarily related to battery management and cybersecurity. It does not describe the development or training of new algorithms for ECG interpretation, nor does it refer to a training set for such algorithms.

9. How the ground truth for the training set was established

• Not applicable. As no training set is mentioned in this submission, the method for establishing its ground truth is not provided.

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