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Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals.

Not intended for home use. Intended for use by health care professionals.

The Telemetry Monitor 5500 is a battery-operated patient worn monitor with a touchscreen display. The Telemetry Monitor 5500 is intended to monitor and record, and to generate alarms for, multiple physiological parameters like ECG, SpO2, and respiration rate. It is equipped with a 1.4 GHz radio to enable wireless bi-directional data flow with Philips' Patient Information Center (PIC) iX.

This 510(k) clearance letter pertains to the Philips Telemetry Monitor 5500 Release 4.0. The provided document focuses on demonstrating substantial equivalence to a predicate device and includes information regarding performance testing against established standards. However, it does not contain specific details about acceptance criteria for particular performance metrics, nor does it describe studies proving the device meets those specific acceptance criteria in the format often associated with AI/ML device clearances (e.g., sensitivity, specificity, AUC).

Instead, the document primarily cites compliance with general medical device standards and internal testing to support its claims of performance. Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., a specific minimum sensitivity or accuracy percentage). Instead, it states that the device was assessed for conformity with relevant standards and that "results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards."

Study Details:

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

   • Test Set Sample Size: Not explicitly stated for any specific performance metric beyond general statements of testing compliance. For the "Clinical Studies" section related to SpO2 accuracy, it only notes that studies were conducted to "support accuracy performance" and "meet the acceptance criteria laid out in the associated protocols." No sample size for patients or data points is provided.
   • Data Provenance: Not specified. The document mentions "Philips conducted clinical studies" but does not detail the country of origin of the data or whether it was retrospective or prospective.

2. 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 Applicable. The document describes performance testing against established standards and internal "accuracy specifications". For the SpO2 accuracy claims, ground truth would typically be established by invasive measurements (e.g., CO-oximetry of arterial blood samples), not by expert review of device output. The document does not provide details on how ground truth was established for the clinical studies supporting SpO2 accuracy.

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

   • Not Applicable/Not Specified. Since expert review for ground truth is not indicated, adjudication methods are not relevant in the context described.

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

   • No. The provided text does not mention any MRMC comparative effectiveness study. This device is a telemetry monitor for physiological parameters, not an AI-assisted diagnostic tool for human readers. "Summative usability testing" was done, indicating human interaction with the device, but not in a comparative effectiveness study involving AI assistance for human "readers."

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

   • Standalone algorithm performance is implied for certain functions, but not detailed. The device uses "Philips proprietary monitoring algorithms for ECG arrhythmia monitoring" (EASI, Hexad, ST/AR Arrhythmia Monitoring, ST/AR ST Analysis Algorithm, ST/AR QT/QTc Interval Monitoring). The performance of these algorithms would constitute "standalone" performance, but the document only states "Functional and system level testing... was performed. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards." No specific performance metrics for these algorithms are provided.

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

   • Not explicitly stated for all performance metrics.
     • For SpO₂ accuracy, ground truth is typically established by comparing the device's SpO₂ readings to invasive arterial blood gas analysis (CO-oximetry). The document only states "Philips conducted clinical studies... to support accuracy performance."
     • For other performance metrics related to compliance with standards (e.g., electrical safety, EMC, usability), the "ground truth" is adherence to the standard's requirements, demonstrated through specific tests.

7. The sample size for the training set

   • Not Applicable/Not Specified. The document mentions "Philips proprietary monitoring algorithms," which would have been developed using training data. However, the size or nature of any training set is not disclosed in this 510(k) summary, as it's not a primary requirement for demonstrating substantial equivalence for this type of device.

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

   • Not Applicable/Not Specified. The document does not provide information on how the ground truth for any potential training sets used in the development of "Philips proprietary monitoring algorithms" was established.

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The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of:

• Symptoms that may be related to rhythm disturbances of the heart in adult patients.
• Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this assessment by a competent health professional.
• Efficacy of antiarrhythmic therapy
• Pacemaker function
• Symptoms that may be associated with myocardial ischemia

The Philips Holter Analysis System is not intended for use for pediatric patients.

The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters:

• Age: Between 33 to 82 years
• Height: Between 147 to 185 cm (58 to 73 inches)
• Weight: Between 53 to 118 kg (117 to 261 lbs)
• Height to Weight Ratio: Between 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)

If patients do not meet these parameters, the EASI derived 12-lead ST measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.

The Philips Holter Analysis System (hereinafter known as Philips HAS) is offered as standalone software. It is intended to be installed into a user's PC (general purpose computing platform). The product evaluates the heart rhythms of ambulatory ECG data over an extended period and generates a preliminary analysis for physician's review. The ECG data is downloaded from compatible ambulatory ECG recorders. It is to be used by trained personnel.

The Philips Holter Analysis System accepts ECG recordings from DigiTrak XT recorders (K071733) and analyzes the patient's heart activity for the recorded period, typically from 24 hours up to 7 days. The analysis is not performed in real time. The DigiTrak XT recorder collects up to 168 hours (7 days) of ambulatory ECG. The software can analyze up to 168 hours (7 days) of contiguous ECG data.

The algorithm (Zymed Algorithm, also internally referred to as the CAlg-Holter Algorithm) used in Holter Analysis System was first developed and approved for use in the Holter Scanner Model 1210. It was continually updated and subsequently cleared for use in more Holter Models. It includes Heart Rate Variability (Time Domain) as a standard software report configuration in March 1996. The operating system converted from a DOS operating system to a Windows operating system in April 1999. Heart Rate Variability Frequency Domain was added in February 2001. The QT analysis was added in September 2001. The most recent 510(k) including above features and functions is under K010949.

The Zymed Algorithm in the HAS incorporates the following enhancements in the subject device:

• Upgraded AFIB detection by replacing the current algorithm with the Philips ST/AR AFIB algorithm's P wave detection feature. The feature was cleared in K101521 with Philips ST/AR ST and Arrhythmia Software.
• Enhanced HRV reporting by replacing current calculations with advanced data warehouse calculations from PhysioNet. Incorporated Nonlinear HRV to provide more characterization of heart rate variability that linear methods could miss.
• Incorporated bug fix, and code security
• Upgraded compiler

The EASI derived 12-lead display function was cleared in K020456. It remains unchanged in the subject device. Philips does not incorporate any additional usage in the subject device beyond these clearances. The EASI 12-lead is only for display purposes, allowing end users to visualize EASI lead ECG recordings in a traditional 12-lead format. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.

No automatic functions or analyses utilize this data. The Zymed Algorithm performs its analysis on the raw ECG signal and does not use the EASI derived 12-lead in that analysis.

The Philips Holter Analysis System requires operator's intervention during and after the initial analysis. The Philips HAS allows the operator to view and print out an analysis report, individual heart rate strips, as well as a full disclosure report for physician's review, diagnoses, and observations. It is intended to assist the qualified medical professional in the interpretation of the recorded data; it is not intended to serve as a substitute for the review and overread of the recorded ECG data.

The Philips Holter Analysis System provides viewing, printing, and report capabilities as listed below:

• A view of the data and a summary of the heart events that have taken place
• Detection of anomalies such as ventricular ectopy and supraventricular ectopy
• Patency of the pacemaker and pacemaker anomalies
• Advanced scanning techniques, such as determining ST and QT anomalies
• Heart rate data and heart rate variability
• Full disclosure reports

The Philips Holter Analysis System can operate in a networked environment that includes the following devices and interfaces to transfer orders and Holter reports.

• Philips IntelliVue Information Center (PIIC) (K153702)
• A fleet of Holter Remote Links and one or more Holter Central Links
• IntelliSpace ECG Management System (ISECG) (K120855)
• An IntelliBridge Enterprise (IBE) data interface engine / brokering system
• DICOM-based enterprise systems

PIC , Holter Remote Links, and Holter Central Links provide alternate ECG input mechanisms for Holter analysis. ISECG Central Link, Report Viewer, and IBE can accept Holter reports. IBE can provide Orders and ADT information for HAS. DICOM-based systems support patient orders via DICOM Modality Worklist and accept exported DICOM Encapsulated PDF reports.

The Philips Holter Analysis System provides three models with different configurations for customers to select: Series 3000, Series 5000, and Series 7000.

The provided text does not contain detailed acceptance criteria or a comprehensive study plan that proves the device meets specific performance metrics in the format of a clinical or analytical validation study for an AI/ML medical device.

The document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence of the Philips Holter Analysis System to a predicate device (2010 Plus Holter for Windows, K010949). The information provided focuses on:

• Device Description and Intended Use: The Philips Holter Analysis System analyzes ambulatory ECG data for various cardiac parameters. It incorporates updated algorithms (e.g., ST/AR AFIB algorithm's P wave detection, enhanced HRV reporting) and supports interoperability. It is intended for adult patients and trained clinicians.
• Comparison to Predicate Device: Detailed tables compare the subject device's indications for use, target population, intended user, intended use environment, and various technological characteristics (e.g., Holter applications, EASI Hookup, supported channels, analysis configuration, arrhythmia and event detection, QT/ST analysis, Pacemaker analysis, Caliper, Important Events, Report Output, Supported ECG source) to the predicate.
• Performance Data Summaries: It states that the device "successfully passed all the testing conducted, and the results demonstrated the Philips Holter Analysis System meets the performance claims and supports a determination of substantial equivalence to the predicate device."
• Non-Clinical Tests - Standards: It lists compliance with several recognized standards (ISO 14971, IEC 62304, IEC 82304-1, IEC 62366-1, IEC 60601-2-47, AAMI EC57). These standards cover risk management, software lifecycle, health software safety, usability engineering, and requirements for ambulatory electrocardiographic systems.
• Non-Clinical Bench Tests: It broadly states that the device was "evaluated against all applicable standards and internal procedures and successfully passed all verifications and validations. The results demonstrated that Philips Holter Analysis System meets all claims and supports a determination of substantial equivalence to the predicate."
• Clinical Studies: It explicitly states that "The Philips Holter Analysis System, like the predicate device, does not require clinical trials."

Missing Information:

The document does not provide the following specifics required to answer your prompt:

• A table of acceptance criteria and reported device performance: While it mentions "performance claims," the actual criteria (e.g., sensitivity, specificity, accuracy targets for specific arrhythmia detection) and the quantitative results are not in the document.
• Sample size used for the test set and data provenance: No details on the size or origin of any specific test datasets used for performance evaluation of the algorithmic changes.
• Number of experts used to establish ground truth and their qualifications: No information on how ground truth was established for any internal performance testing.
• Adjudication method for the test set: No mention of adjudication.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document clearly states no clinical trials were required. Thus, no MRMC study details are available.
• Standalone (algorithm only) performance: While the document describes software updates, it does not explicitly provide standalone performance metrics for the AI/ML components (like the upgraded AFIB detection or enhanced HRV). The entire device is presented as assisting clinicians, not replacing them.
• Type of ground truth used: No specific type of ground truth is detailed for performance evaluation, beyond stating it passed internal verification and validation against claims.
• Sample size for the training set: No information on training data is provided.
• How ground truth for the training set was established: No information on this.

Conclusion based on the provided text:

The Philips Holter Analysis System received 510(k) clearance based on substantial equivalence to a predicate device, supported by compliance with recognized standards and successful completion of non-clinical bench testing, software verification and validation, usability validation, and risk management activities. This regulatory pathway typically does not require extensive clinical trial data detailing specific algorithmic performance metrics or human-AI interaction studies as might be submitted for novel AI/ML devices with significantly different indications or technological characteristics. The document emphasizes adherence to engineering and quality standards, and broad performance claims rather than specific quantitative performance targets and studies.

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Philips IntelliVue reusable ECG lead sets/trunk cables and Philips OR ECG trunk cables are indicated for continuous monitoring of cardiac signals for both diagnostic and monitoring purposes. These devices are limited by the indications for use of the connected monitoring and diagnostic equipment in healthcare facilities. These devices are intended to interact with patient intact skin only.

Philips Reusable ECG Lead Sets and Trunk Cables are non-invasive reusable medical devices designed to transfer ECG signals from the patient to the monitor used in the healthcare facilities, which includes intensive care unit (ICU) for both adults and neonates and the operating room (OR). The ECG cables and lead sets are used to forward an electrical cardiac signal via electrical wires from the electrode attached on patient skin to the ECG measurement hardware in the patient monitor and to support other outputs as needed. The portfolio consists of two types of trunk cables and two types of lead sets: ICU and OR, including various electrode connectors with AAMI and IEC coloring. The ECG Trunk cables and lead sets are suitable for multiple patient use. The Philips Reusable ECG Lead Sets and Trunk Cables have a service life of 18 months. The Philips Reusable ECG Lead Sets and Trunk Cables can be used with any Philips monitors including Philips monitor/defibrillator product lines and Philips monitoring or diagnostic equipment which claim compatibility to Philips Reusable ECG Lead Sets and Trunk Cables.

This document is a 510(k) premarket notification for Philips Reusable ECG Lead Sets and Trunk Cables. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study with clinical accuracy metrics. Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth are not applicable or explicitly stated in this type of submission.

However, I can extract the information that is present regarding performance testing and standards.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of specific quantitative clinical acceptance criteria and device performance metrics, this submission relies on compliance with recognized harmonized standards. The "performance" is demonstrated through successful completion of tests outlined in these standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document explicitly states: "The subject devices, like the primary predicate devices, did not require clinical trials." Therefore, there is no "test set" in the context of a clinical study for external validation of performance. Performance is primarily demonstrated through compliance with recognized standards via non-clinical bench testing. The data provenance would be from internal lab testing, not patient data.

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 applicable. No clinical test set requiring expert ground truth was used as per the statement above.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication was used.

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 applicable. This device is an ECG cable and lead set, a hardware accessory. It is not an AI algorithm for interpreting medical images or signals, nor does it involve "human readers" or "AI assistance" in that sense.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware accessory, not an algorithm. Performance is assessed through its physical and electrical properties, not algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the sense of clinical ground truth. For non-clinical bench testing, the "ground truth" would be established by the specifications and measurement techniques defined within the harmonized standards (e.g., electrical resistance, mechanical durability measured against stated tolerances, biocompatibility testing results).

8. The sample size for the training set
Not applicable. This is a hardware accessory, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set.

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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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The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and

The IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors.

The monitors support multiple non-invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse.

The monitor models MX750 and MX850 differ mainly in size. While MX750 has a 19" flat panel display, MX850 has a 22″ display.

This K221348 510(k) summary document describes the Philips IntelliVue Patient Monitor MX750 and MX850. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of compatibility with external Masimo measurement devices.

Based on the provided document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria (e.g., accuracy, precision thresholds) for each physiological parameter measured by the IntelliVue Patient Monitors MX750 and MX850, nor does it provide detailed reported performance values for these criteria in the context of this specific 510(k) submission.

Instead, the document states:

• "Performance specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications remain unchanged" from the predicate devices.
• "performance specifications of the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine remain unchanged."

This implies that the acceptance criteria and reported device performance for the core functionalities of the IntelliVue Patient Monitor MX750 and MX850 (excluding the newly added external measurements) are inherently covered by the predicate devices they are compared against. For the newly integrated Masimo modules, their performance criteria and data are derived from their own prior clearances (K162603, K123043, K171121, K172890).

Therefore, a table cannot be directly constructed from this document as it doesn't provide new, specific performance data for the current submission's acceptance criteria beyond referencing existing performance.

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

The document states:

• "Non-clinical Bench Tests: There were no new questions of safety or effectiveness introduced as a result of using this device."
• "Clinical Studies: The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo O3, IRMA CO2, ISA CO2 and SedLine parameters are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor."

This indicates that no new test set (clinical or otherwise) with a specific sample size was used for this 510(k) submission to evaluate the primary IntelliVue devices' performance beyond what was established for their predicates. The assessment relies on the existing validation of the predicate IntelliVue device and the individual Masimo modules.

Therefore, sample sizes for a new test set are not applicable here. The provenance of existing data would refer to the previous submissions for the predicate IntelliVue devices and the Masimo modules, which are not detailed in this document.

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

As no new clinical studies or test sets were conducted for this 510(k) submission to establish new performance data, there is no information provided regarding a number of experts used to establish ground truth or their qualifications. The submission asserts that the performance characteristics (and thus, the ground truth establishment) of the individual components (IntelliVue monitor and Masimo modules) remain unchanged from their prior clearances.

4. Adjudication Method for the Test Set

Since no new test set was generated for this 510(k) submission (as per point 2), no adjudication method specific to this submission's test set is detailed.

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

The document states that "The subject devices, like the primary predicate devices, did not require clinical trials." This implies that no MRMC comparative effectiveness study was performed for this submission. The device is a patient monitor, not typically evaluated with MRMC studies in the way imaging AI algorithms are.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

The document focuses on the integration of external modules into an existing patient monitor. While the individual Masimo modules (O3, IRMA CO2, ISA CO2, SedLine) likely had standalone performance studies as part of their original clearances, this 510(k) document does not report new standalone performance studies for the integrated system or its individual components in this context. The core assertion is that the measurements are not modified, only the host monitor connection.

7. Type of Ground Truth Used

Given that no new studies were conducted, the document implicitly relies on the ground truth established during the previous clearances of the predicate IntelliVue monitors and the Masimo modules. The specific types of ground truth for these physiological parameters would typically involve:

• Reference standard measurements: Comparison against highly accurate and precise clinical instruments for parameters like ECG, SpO2, blood pressure, CO2.
• Clinical observation and expert interpretation: For conditions like arrhythmia detection (ECG) or state of brain monitoring (EEG/BIS/SedLine), ground truth might involve expert review of physiological waveforms and patient state.
• Pathology/Outcomes data: Not explicitly mentioned or typically applicable for patient monitoring as a primary ground truth.

However, this document does not detail the specific ground truth methodologies used in those prior studies.

8. Sample Size for the Training Set

The document describes a 510(k) submission for a patient monitor and the integration of external modules. This type of device relies on established algorithms for physiological parameter measurement, rather than a machine learning model that requires a distinct "training set" in the common sense of AI/ML software. Therefore, the concept of a "training set sample size" as typically used for AI/ML does not directly apply or is not detailed here. The algorithms used in the Masimo modules and the Philips monitor were developed and validated, but this process doesn't align with a "training set" in the AI/ML context.

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

As explained in point 8, the concept of a "training set" in the AI/ML sense is not applicable or detailed in this document for these types of patient monitoring algorithms. Therefore, information on how ground truth for a training set was established is not present. The algorithms' foundational accuracy would have been established through a combination of engineering, physiological principles, and validation against clinical reference standards, as mentioned above for "Type of Ground Truth."

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