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The Cardiac Workstation is intended 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. They are 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 Cardiac Workstation 5000 (aka: CW 5000) and Cardiac Workstation 7000 (aka: CW 7000) are intended 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. They are 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 for review by the user.

The interpreted ECG with measurements and interpretive statements are offered to the clinician on an advisory basis only. They are 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.

The CW 5000 and CW 7000 are mid- and high-range interpretive cardiographs, differing primarily in display size, the number of standard options. Both devices offer a full array of features built on the Linux operating system, with touch screen operation, a configurable feature set, and interpretation from the clinically proven Philips DXL ECG Algorithm (K132068). They provide a cardiograph solution for hospitals and cardiology clinics in processing large volumes of ECGs. The DXL ECG algorithm in the software analyzes up-to 18 leads of simultaneously acquired ECG waveform to interpret rhythm and morphology for a variety of patient populations. The measurements are then analyzed by the DXL ECG Algorithm. The resulting ECG reports may include ECG measurements, reasons, or analysis statements. The algorithm covers both adult and pediatric populations.

The CW 5000 and CW 7000 consist of the following:

• An electrocardiograph device with integrated display and printer. CW 5000 provides 12.1'' display panel. CW 7000 provides 15.6″ and 18.5″ options for the display panel.
• Optional Trolley (ordered via a separate part number)

The subject devices are further structured with options relating to software. Ul language, keyboard locale, and a wide range of other configuration choices to optimize the user's experience with the devices.

The Philips Cardiac Workstation 5000 and 7000 are ECG devices designed to acquire, record, display, analyze, and store multi-channel ECG signals for review. The analysis is performed by algorithms providing measurements, data presentations, graphical representations, and interpretations.

The study presented in the provided context for the Cardiac Workstation 5000 and 7000 is a non-clinical bench testing study, primarily focused on demonstrating substantial equivalence to a predicate device (PageWriter TC70 Cardiograph, K210560).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed as compliance with harmonized standards and successful completion of various bench tests, aiming to show performance similar to the predicate device. Specific quantitative performance metrics for the standalone algorithm are not detailed in the provided text, as the focus is on overall device equivalence.

2. Sample Size for the Test Set and Data Provenance

The document does not detail specific sample sizes for a 'test set' in the traditional sense of a clinical or algorithm performance study. The evidence provided is primarily focused on bench testing against harmonized standards and comparison to a predicate device. Therefore, the "test set" would refer to the tests and evaluations conducted on the devices themselves rather than a dataset of patient ECGs.

The data provenance for any internal testing is not explicitly stated in terms of country of origin or retrospective/prospective nature regarding patient data. However, the harmonized standards (e.g., IEC, ANSI/AAMI, ISO, ASTM) are international or US-based.

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

No information is provided about experts establishing ground truth for a test set. This type of information would typically be present in a clinical or algorithm validation study. Since this is a substantial equivalence submission based on non-clinical bench testing, the ground truth refers to compliance with established technical specifications and standards rather than clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable, as the provided document describes non-clinical bench testing and compliance with standards, not a study involving expert adjudication of clinical outcomes.

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 MRMC comparative effectiveness study was done. The document explicitly states: "The Cardiac Workstation 5000 and Cardiac Workstation 7000, like the predicate device (K210560), did not require clinical studies to demonstrate substantial equivalence." The algorithm ("Philips DXL ECG Algorithm", K132068) is mentioned as previously cleared. This submission focuses on the hardware device's equivalence and updated features, not new claims about AI performance or human-AI interaction.

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

The document states that the devices use the "clinically proven Philips DXL ECG Algorithm (K132068)" or "same cleared ECG algorithm (PH110C) for ECG measurement and interpretation." This implies that the algorithm's standalone performance was likely established in its original K132068 submission. This current submission for the Cardiac Workstation 5000/7000 leverages that existing clearance and does not provide new standalone algorithm performance data. The mention of the algorithm being "advisory basis only" and requiring "a qualified physician to over-read and validate (or change) the computer-generated ECG interpretation" confirms it is not intended for standalone diagnostic use without human oversight.

7. The Type of Ground Truth Used

For the specific non-clinical bench tests described in this document, the "ground truth" is compliance with harmonized technical standards and internal specifications. For the underlying DXL ECG algorithm, its original clearance (K132068) would have established its ground truth, likely using expert consensus ECG interpretations, and potentially clinical outcomes or pathology, but details are not provided in this document.

8. The Sample Size for the Training Set

The document does not provide a sample size for the training set. This information would pertain to the development of the DXL ECG algorithm, which was already cleared under K132068. This submission is for the Cardiac Workstation devices incorporating the already cleared algorithm.

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

This information is not provided in the document. It would have been part of the original submission for the Philips DXL ECG Algorithm (K132068).

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