(227 days)
The PageWriter TC35 Cardiograph 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. 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.
The PageWriter TC35 Cardiograph is intended to acquire, record, analyze and store multi-channel ECG signals from adult and pediatric patients through a body surface ECG electrode. The device is integrated with the cleared algorithm (K132068) to provide measurements, and interpretations for review by the clinical on an advisory basis. The interpretated ECG with measurement and interpretative statements are to be used in conjunction with 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.
PageWriter TC35 Cardiograph has LCD display with touchscreen, keyboard and functional buttons. The device can be powered from AC power or through an embedded re-chargeable battery. The device contains built-in thermal printer for ECG report printing. The device contains USB ports, LAN port and optional WiFi interface for communications.
PageWriter TC35 Cardiograph has various configurations provided for the preference of the user, and it can be updated with the compatible options/modules from the corresponding upgrade Kit (the upgrade kit is not considered as a device kit, refer to the Table 10-2 for the details of configuration list) for use with all approved accessories and spare parts, including patient cables, print papers and trolleys. None of the accessories and spare parts are provided sterile.
Once configured, PageWriter TC35 cardiograph can provides integrated connectivity (wired or wireless) with the compatible Philips IntelliSpace ECG Management System, IntelliBridge Enterprise (IBE), DICOM for patient order download and ECG report transmission. The cybersecurity on PageWriter TC cardiograph is periodically and proactively improved according to the cybersecurity analysis and the routine device cyber maintenance plan.
The provided text describes the Philips PageWriter TC35 Cardiograph, indicating that no clinical studies were required to demonstrate substantial equivalence to its predicate device, the PageWriter TC20 Cardiograph (K210560). Therefore, the document does not contain information related to specific acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or comparative effectiveness studies (MRMC) with human readers improvement against AI.
However, the document does list the non-clinical tests and standards that the device passed to demonstrate compliance and substantial equivalence.
Here's a summary of the information available based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of performance metrics with specific acceptance criteria and reported values. Instead, it states that the device "successfully passed all verifications, testing and validations" against harmonized standards and internal procedures.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety | Passed all safety tests |
| Electromagnetic Compatibility | Passed all EMC tests |
| Cybersecurity | Passed all cybersecurity tests |
| Software Functionality | Passed software functional verification |
| Environment and Reliability | Passed environment and reliability tests |
| Mechanical and Hardware | Passed mechanical and hardware tests |
| Packaging | Passed packaging tests |
| Human Factors and Usability | Passed human factor and usability performance tests |
| Electrical Safety | Passed electrical safety tests |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document states "Non-clinical bench testing activities establish the performance, functionality, and reliability characteristics of the subject device... The PageWriter TC35 Cardiograph was evaluated against all applicable standards and internal procedures, and successfully passed all verifications, testing and validations." This implies a series of engineering tests rather than a clinical dataset.
- Data Provenance: Not applicable, as this refers to non-clinical bench testing and verification against standards, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no expert-established ground truth from a clinical test set is mentioned. The device's performance was evaluated against technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring expert adjudication is mentioned.
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 PageWriter TC35 Cardiograph like the predicate device (K210560), it did not require clinical studies to demonstrate substantial equivalence." The device provides "interpretations for review by the clinical on an advisory basis" and requires a "qualified physician is asked to over read and validate (or change) the computer-generated ECG interpretation," indicating a human-in-the-loop system where the AI provides advisory input.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device's ECG interpretation algorithm (PH110C) is mentioned as a "cleared algorithm" and provides advisory interpretations to the clinician. The document does not describe standalone performance testing of this algorithm without human-in-the-loop, nor does it provide its specific performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for the non-clinical tests described. For the integrated ECG interpretation algorithm, the method for establishing its "ground truth" (during its own clearance, K132068, which is referenced in the device description) is not detailed in this document.
8. The sample size for the training set:
Not applicable. The document does not describe the training of an AI algorithm, but rather the performance validation of a medical device against technical standards. The integrated ECG algorithm (PH110C) is presented as a pre-existing "cleared algorithm."
9. How the ground truth for the training set was established:
Not applicable, as no training set for the current device is described. The ground truth for the previously cleared algorithm (K132068) is not detailed in this document.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).