(125 days)
Philips Electrocardiograph, Page Writer TC cardiograph (TC20, TC30, TC50, and TC70) 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 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.
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 provided text describes a 510(k) premarket notification for Philips Electrocardiograph PageWriter TC20, TC30, TC50, and TC70 devices with the addition of a Vectorcardiograph (VCG) function.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document states that the modification to the devices was to provide a configurable VCG report in addition to existing 12-Lead Auto ECG reports. The VCG data is derived from an existing DXL 12/16-Lead ECG algorithm. The acceptance criteria and performance are not presented in a formal table but are discussed within the "Performance Data" section.
| Acceptance Criteria Category | Specific Criteria / Evaluation | Reported Device Performance / Outcome |
|---|---|---|
| Electrical Safety | Compliance with consensus standards. | Determined that the proposed modification did not require additional testing. In compliance with IEC 60601-2-25. |
| Electromagnetic Compatibility (EMC) | Compliance with consensus standards. | Determined that the proposed modification did not require additional testing. In compliance with IEC 60601-1-2. |
| Usability | Compliance with consensus standards. | Determined that the proposed modification did not require additional testing. In compliance with IEC 62366-1. |
| Software Functionality (VCG Report) | Verify ability to present VCG report. Ensure VCG loop is in correct direction (rotation). Ensure VCG loop has accurate magnitude. | Software functional testing was performed and verified these aspects. |
| Software Development | Compliance with IEC 62304:2006/A1:2015. | Developed in compliance with this standard. |
| Cybersecurity | Effectiveness of existing security measures. | Proposed change did not impact the effectiveness of security measures. |
| Impact on other device functions | No impact on other functions. | No other functions of the subject devices were impacted. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for any test set or the data provenance. It only mentions that software functional testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
The document does not provide this information. The performance data focuses on technical compliance and software functionality rather than clinical accuracy adjudicated by experts for the new VCG functionality itself. The existing DXL algorithm is referenced, but details about its validation or expert oversight for this specific submission are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method for a test set. This type of method would typically be relevant for clinical performance studies involving interpretation, which this submission explicitly states was not required.
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, an MRMC comparative effectiveness study was not done. The document explicitly states: "This premarket submission did not require clinical study to demonstrate the substantial equivalence." The device is presenting VCG data derived from an existing algorithm, and the focus of this submission is on the presentation of this data, not a new interpretive AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device's core functionality is an electrocardiograph. The VCG feature is an addition to this existing device. The VCG data itself is derived from an existing "DXL 12/16-Lead ECG algorithm." The software functional testing was performed on the device's ability to render and present the VCG report. It doesn't describe a standalone performance study of the DXL algorithm itself in the context of this submission, but rather the integration and correct display of its output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the specific aspect validated in this submission (rendering and presentation of the VCG report), the "ground truth" implicitly referred to is the correctness of the derived Frank lead signals and their proper conversion into vector loops with accurate direction and magnitude. This isn't a clinical ground truth like pathology, but a technical ground truth based on the expected output from the DXL algorithm and proper graphical representation.
8. The sample size for the training set:
The document does not mention a training set. This submission concerns a physical device and the integration of a new display feature for an existing algorithm. Machine learning models, which require training sets, are not discussed in the context of this submission's modifications.
9. How the ground truth for the training set was established:
Not applicable, as no training set is mentioned or relevant to the scope of this particular 510(k) submission.
§ 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).