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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.

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.

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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.

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.

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SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements is offered to clinicians on an advisory basis only. It is mainly used in the ECG Outpatient Department and Physical Examination Department.

SE-1515 is a PC-based ECG designed to acquire, process and store ECG signals and analyze and diagnose heart disease. SE-1515 consists of analysis software and sampling boxes, and has four configurations: Wired 18-lead ECG system, Wired 16-lead ECG system, Wired 12-lead ECG system and Wireless 12-lead ECG system. Wired 18-lead ECG system consists of analysis software and wired DE18 sampling box. Wired 16-lead ECG system consists of analysis software and wired DE15 sampling box. Wired 12-lead ECG system consists of analysis software and wired DP12 sampling box. Wireless 12-lead ECG system contains analysis software, wireless DX12 sampling boxes (DX12 transmitter and DX12 receiver). The communication between DX12 transmitter and DX12 receiver is based on Bluetooth technology. For stress exercise testing, the user should connect a BP monitor and a treadmill or an ergo meter to the PC.

Here's a breakdown of the acceptance criteria and the study information for the EDAN Instruments, Inc. PC ECG, model SE-1515, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating
substantial equivalence to predicate devices, not necessarily a detailed clinical
effectiveness study itself. Therefore, specific details about acceptance criteria, ground truth
establishment (especially for a new algorithm), and effect sizes from MRMC studies are often
not explicitly stated in this type of document. The information below is extracted directly
from the text; if a point is not mentioned, it's because the document does not provide it.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" but rather compares the performance parameters of the SE-1515 with its predicate devices (SE-1010, Philips DXL 12/16-lead ECG Algorithm, Philips TC70). The implicit acceptance criteria are that the new device's performance should be similar or comparable to the predicate devices, or that any differences do not raise new questions of safety or effectiveness.

Below is a table summarizing the performance comparison, highlighting where quantitative parameters are presented. Since "Remark" column indicates "Same," "Different," or "---", for the purpose of showing "acceptance criteria" and "reported device performance", the "predicate value" can be considered as the implicit acceptance criteria that the new device needs to meet to establish substantial equivalence.

Study Information:

1. Sample size used for the test set and the data provenance:

   • The document mentions "database testing" for ECG interpretation features but does not specify the sample size for this test set or the provenance (country of origin, retrospective/prospective nature) of the data.

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

   • This information is not provided in the document. The document refers to "ECG interpretation features... validated by database testing," but details on the ground truth establishment for this validation are absent.

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

   • This information is not provided in the document.

4. 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:

   • An MRMC comparative effectiveness study, particularly one measuring human reader improvement with AI assistance, was not indicated. The comparison is mainly against predicate devices, focusing on technical specifications and substantial equivalence, not algorithm-assisted human reading.

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

   • The document states, "ECG interpretation features were also validated by database testing." This implies a standalone performance evaluation of the algorithm against a database, though details are missing. The device's indications for use also state that the "ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," suggesting a standalone interpretive function.

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

   • For the "ECG interpretation features," the document mentions "database testing." However, the specific type of ground truth used within this database (e.g., expert consensus diagnoses, correlation with patient outcomes, or other clinical data) is not specified.

7. The sample size for the training set:

   • The document does not specify a training set and its size. The validation focuses on the device's performance and ECG interpretation features using "database testing."

8. How the ground truth for the training set was established:

   • Since no training set is explicitly mentioned or described, the method for establishing its ground truth is also not provided.

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