Search Results

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.

Ask a specific question about this device

The Philips ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The cardiac data provided by the Stress system is intended to be reviewed, confirmed, and used by trained medical personnel to assist in the evaluation of the patient's cardiovascular condition and the patient's physiological condition during stress exercise testing. The arrhythmia detection portion of the ST80i Stress Exercise System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.

The Philips ST80i Stress Test System is indicated for use in exercise ECG testing where the clinician decides to evaluate the electrocardiogram of patients at 10 years or older, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms of cardiovascular disease. The Philips ST80i Stress Test System is not intended to be used as a physiological monitor.

The ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data (resting and physiologic) of patients undergoing stress exercise testing and acquire data from ancillary devices (such as SpO2 and Ambulatory Blood Pressure). The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The arrhythmia detection portion of ST80i Stress Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The cardiac data provided by the stress system is intended to be reviewed, confirmed and used for diagnostic purposes by trained medical personnel to assist in the diagnosis of coronary artery disease (CAD) and the patient's physiological condition during stress exercise testing. The ST80i Stress Test System will be offered in two versions which are a complete turnkey system which includes an ECG data acquisition module, trolley with a PC loaded with the application software and optional thermal printer or a minimal system with the application software and data acquisition module only.

The Philips ST80i Stress Test System is a PC-based diagnostic tool designed to acquire, process, and store ECG data during stress exercise testing. It records ECG, heart rate, and ST data, generates summary tables, trends, and reports for cardiac data indices. The system's arrhythmia detection offers convenience but does not provide alarms. It is intended to assist trained medical personnel in evaluating cardiovascular conditions, diagnosing coronary artery disease (CAD), and assessing physiological conditions during stress exercise testing for patients 10 years or older. It is not intended as a physiological monitor.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ST80i Stress Test System are largely demonstrated through its equivalence to the predicate devices, CASE V6.6 and CS V6.6 Cardiac Testing Systems. The provided documentation presents a comparison of specifications and features rather than explicit acceptance criteria with numerical targets. The "Comparison" column indicates whether the ST80i's performance is "Same," "Similar," or "Different" to the predicate.

Ask a specific question about this device

Xper Flex Cardio Physiomonitoring System-The physiomonitoring system is intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing. and analytical assessment. The system is indicated for use in the cardiac catheterization, following areas: cardiology, electrophysiology, radiology, invasive radiology and other areas where cardiac monitoring may be required. The system is not intended to be used in the proximity of magnetic resonance imaging. The data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required.

The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device.

Xper Information Management- The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data. such as physiologic/ hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multichannel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

The system is indicated for use in the following areas: cardiology, cardiac catheterization. electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed.

The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system.

The system is capable of receiving and displaying user-adjustable alarms (both visual and audible) available in the system, which alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required.

The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device.

The Xper Flex Cardio physiomonitoring system and Xper Information Management systems are enhancements of the cleared Xper Information Management system (K063840).

The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, SpO2 (pulse oximetry), end tidal CO2 (ETCO2) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status. The Xper Flex Cardio physiomonitoring system is not intended for use in the proximity of magnetic resonance imaging.

The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices.

The provided 510(k) summary for the "Xper Flex Cardio Physiomonitoring System" and "Xper Information Management System" does not describe acceptance criteria for specific performance metrics or a study that rigorously proves the device meets those criteria in terms of clinical accuracy or effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

• Technological Characteristics: Highlighting similarities in intended use, components, and functionalities with existing cleared devices.
• Performance Testing (Compliance to Standards): Showing the device complies with relevant international electrotechnical commission (IEC) safety and electromagnetic compatibility (EMC) standards. This is a common method for medical devices to show basic safety and performance in their specific operating environment.

Here's an breakdown based on your requested information, with the understanding that the provided document does not contain the level of detail you might expect for an AI-centric device's performance study:

1. Table of Acceptance Criteria and Reported Device Performance

• "The results of the safety and performance testing demonstrate that the Xper Flex Cardio physiomonitoring system and the Xper Information Management System are as safe and effective as the predicate device(s) and perform as well as the predicate device(s)."
  - Compliance with voluntary standards (IEC 60601 series). |
  | Safety & EMC | Compliance with the following voluntary standards:
• IEC 60601-1 (General Requirements for Safety)
• IEC 60601-1-1
• EN 60601-1-2
• IEC 60601-2-30
• IEC 60601-2-49 |
  | System Functionality | The device is capable of:
  - Displaying and analyzing surface ECG, respiration, invasive pressure, SpO2, ETCO2, NIBP, surface body temperature, thermal cardiac output curves.
• Processing/analyzing multi-channel ECG signals, displaying graphical ST segment maps.
• Acquiring, displaying, trending, storing, and transmitting various types of data (physiologic/hemodynamic, clinical, medical image).
• Creating reports.
• Receiving and displaying user-adjustable visual and audible alarms.
• Transmitting patient data files for storage, viewing, and analysis. |
  | Substantial Equivalence | Demonstrated by comparing the device's technological characteristics, intended use, and performance testing results to several predicate devices (Xper Information Management System K063840, GE MacLab/CardioLab EP/ComboLab System K050093, Poise DataEngine K040969, Siemens AXIOM Sensis K020440, Alliance Instruments Integrity Patient Monitor K980688). |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document refers to "Performance Testing" and "hazard analysis" which implies testing was conducted, but details on sample size (e.g., number of patients, number of data points) are absent.
• Data Provenance: Not specified.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

• Number of Experts: Not applicable. The submission does not describe a study involving expert review for ground truth establishment.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? The document refers to the introduction of a "Philips ECG algorithm (individually cleared in K073376)". While this indicates an algorithm is part of the system, the provided 510(k) for the current device does not detail a standalone performance study for this specific algorithm or any other algorithms within the system in this submission. Its prior clearance implies a study was done for that specific component at that time.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated as expert consensus, pathology, or outcomes data for the overall system. The performance testing is primarily focused on compliance with safety and electrical standards and demonstrating functionality, rather than establishing a clinical ground truth for diagnostic accuracy in a patient cohort.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The document does not describe a training set in the context of machine learning or AI model development for the device as a whole. While an ECG algorithm is mentioned, its training details are not part of this submission.

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

• How Ground Truth was Established: Not applicable. As no training set is described for the device in this submission, the method for establishing its ground truth is not mentioned.

Ask a specific question about this device

Where the clinician decides to monitor cardiac arthythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatic, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediation of adult patient ECG's for heart rate and ventricular arthythmias, and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.

Note: The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.

The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatic and adult patients with and without symptoms of arrhythmia. OT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

RLS ECG is intended for monitoring multiple leads of ECG of adults.

RLS ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The modification is a software-based change that adds the following features:
· Support derived 12-lead ECG (RLS ECG) from a 6-electrode lead set.
· Provide enhanced AF and Irregular HR alarms detection
· Provide enhanced QT and ST analysis and alarms.

The provided text is a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release K.0. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a study proving the device meets said criteria in the format requested.

Here's an analysis of what is and is not provided, based on your request:

1. A table of acceptance criteria and the reported device performance

• Not provided. The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test.results showed substantial equivalence. The results demonstrate that ST/AR Release K.O meets all defined reliability requirements and performance claims."
• This statement indicates that acceptance criteria (pass/fail criteria) were established and met, but it does not specify what those criteria were (e.g., sensitivity, specificity, accuracy targets) nor does it report the device's performance against those criteria with specific metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not detail the sample sizes for these tests or the nature of the data (e.g., patient population, retrospective/prospective).

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)

• Not provided. The document does not describe the establishment of a "ground truth" using experts for performance evaluation. The testing described focuses on functional equivalence to predicate devices and adherence to existing specifications.

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

• Not provided. There is no mention of an adjudication process for the test set.

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

• Not provided. This document describes a software update for a physiological monitor with expanded features (e.g., derived 12-lead ECG, enhanced AF/Irregular HR alarms, enhanced QT/ST analysis). It is not focused on an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study to assess human reader improvement. The focus appears to be on the algorithm's performance itself, rather than its impact on human interpretation.

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

• Implied, but not explicitly detailed. The statement "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate" suggests that the algorithm itself was tested for performance against established specifications. However, specific metrics (like sensitivity, specificity, accuracy) are not provided in this summary. The testing appears to be focused on whether the new features function as intended and meet the specifications set for the predicate device.

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

• Not explicitly stated how ground truth was established, if at all, for performance claims. The document uses the term "specifications cleared for the predicate device" as the basis for pass/fail criteria. This suggests that the ground truth for evaluation would be derived from comparisons to the expected outputs or performance of the cleared predicate devices, rather than an independent clinical ground truth like pathology or expert consensus on new data.

8. The sample size for the training set

• Not provided. Training sets are typically associated with machine learning or AI development. While the device includes "algorithms" (e.g., ST/AR arrhythmia analysis algorithm, ST/AR ST analysis algorithm), this document does not provide details of their development processes that would include training sets. Given the submission date (2010), these algorithms likely rely on more traditional signal processing and rule-based methods rather than large-scale machine learning requiring explicit "training sets" in the modern sense.

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

• Not applicable / Not provided. As no training set information is given, the method for establishing its ground truth is also not mentioned.

In summary, this 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices. It confirms that testing was conducted and specifications were met, but it does not provide the detailed performance metrics, study designs, or ground truth establishment methods typically requested for a deeper understanding of a device's clinical performance and validation against specific acceptance criteria. The "study" mentioned is a general "Verification, validation, and testing" activity, not a specific clinical trial with reported outcomes.

Ask a specific question about this device