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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 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 and recording 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 additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. 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 EC 11).

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

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

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 pediatric 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 noninvasive monitoring 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 MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, 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 at the patient bedside vicinity and can also be used during patient transport inside hospitals.

The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

Here's a breakdown of the acceptance criteria and the study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided FDA 510(k) summary:

This submission is a 510(k) for modifications to an existing device, the IntelliVue Patient Monitors MX500 and MX550. The acceptance criteria and supporting studies primarily focus on demonstrating that the modifications do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an update to an existing device focusing on integrating new measurement modules (Masimo O3, IRMA CO2, ISA CO2) and updating EMC standards, the "acceptance criteria" are primarily related to meeting established performance standards for patient monitors and demonstrating that the new modules function as intended without compromising the overall device safety or efficacy. The document doesn't present specific numerical acceptance criteria for all physiological parameters of the overall monitor, but rather confirms compliance with recognized standards.

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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 and recording 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 MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

The monitors are only for use on one patient at a time. 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 EC 11).

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

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

The SSC Sepsis Protocol, in the Protocol Watch 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 Masimo rainbow SET measurement is indicated for the noninvasive monitoring 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 transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

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 pediatric 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 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 IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, ScvO2, spirometry, 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. Several monitor models can also be used mobile, during patient transport inside or outside of hospitals.

The monitors have a color display with touch-screen and/or keys and a navigation point as a primary input device. They also support further local input devices such as specialized remote control, keyboard, and mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

With the current software Rev. N.0 the following modifications have been introduced:

• Implementation of the existing feature Alarm Advisor into the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3. Alarm Advisor provides feedback on recurring and continuous alarm limit violations based on configured criteria. The information provided by the Alarm Advisor supports device operator in adapting alarm limits more specifically. This is the same functionality as that in other IntelliVue Patient Monitors: MP5, MP5SC, MX400, MX430, MX450, MX500, MX550, MX700, and MX800 (cleared with K161531).
• Modification of a few specific elements of the Graphical User Interface (GUI) of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, and the Intelli Vue Multi-Measurement Module X3:
  • The key 'Silence' has been renamed to 'Acknowledge',
  • A new default configuration for the Pause/Switch off of alarms via 'Acknowledge' key combined with a specific pop-up window has been added to all monitor models,
  • New default configurations of visual alarm indicators with other colors and flashing behavior of the alarm numerics and limits have been added.

The provided document is a 510(k) premarket notification from Philips Medizin Systeme Boeblingen GmbH to the FDA for their IntelliVue Patient Monitors. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and addressing minor software modifications, specifically the implementation of an "Alarm Advisor" feature and GUI changes related to alarm management.

The document does not contain the specific details required to answer all parts of your request, particularly regarding clinical performance studies with specific acceptance criteria, sample sizes for test and training sets, expert consensus, or MRMC studies for an AI device. This is because the submission is for a patient monitor and its software updates, not an AI-powered diagnostic device in the sense that would require such extensive clinical validation to demonstrate improved human reader performance or standalone algorithm performance.

However, I can extract information related to the acceptance criteria and study proving the device meets its acceptance criteria, based on the scope of this type of submission.

Here's an analysis based on the provided text, while acknowledging the limitations for a full AI device performance study:

Acceptance Criteria and Device Performance (as evident from this 510(k) submission):

For this type of device (patient monitors with software updates), the "acceptance criteria" and "device performance" are primarily demonstrated through compliance with recognized standards, hazard analysis, and functional/regression testing rather than a clinical trial with a defined performance metric like sensitivity/specificity for a diagnostic AI.

Study Details (based on the provided document):

Given that this is a 510(k) for patient monitors with minor software updates, the "study" is primarily a series of verification and validation (V&V) activities focused on engineering and software aspects, rather than a clinical trial for an AI diagnostic.

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify a "test set" in the context of a dataset for an AI model. Instead, it refers to V&V activities that include:
     • Hazard Analysis Testing: "All specified pass/fail criteria have been met." (No specific sample size of incidents/scenarios mentioned, typically an engineering analysis).
     • Functional System Level Tests: Performed on a variety of monitor models (MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, Multi-Measurement Module X3) for the new features (Alarm Advisor, blinking numerics, Alarm Acknowledge, Pause/Switch off Alarms). No specific number of test cases or "patients" is provided.
     • Regression Tests: Performed on the same range of monitor models to ensure unchanged functions still work.
   • Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The tests are performed on the device itself and its software.

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

   • Not described as "ground truth" establishment in this context. For usability testing, it mentions "expert reviews" as part of formative evaluations, but the specific number and qualifications of these experts are not detailed. These would typically be human factors engineers, clinical specialists, or design experts.

3. Adjudication Method for the Test Set:

   • Not applicable as there is no "test set" of clinical cases requiring adjudication. The V&V activities are based on engineering specifications and standard compliance.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This submission is for patient monitors and their alarm management and GUI features, which do not involve diagnostic interpretation in that manner. The "Alarm Advisor" provides feedback on alarm limit violations, which is a clinical decision support tool related to device settings, not an image interpretation aid.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

   • Yes, to an extent, in the sense that the new software features were functionally tested independently of human interaction (e.g., "Functional tests... All tests have been passed"). The "Alarm Advisor" functionality and GUI changes needed to perform as specified by the algorithm/software design. However, this is not a "standalone performance study" in the context of an AI diagnostic that might output a diagnosis or risk score. It's more about verifying software logic and output.

6. The Type of Ground Truth Used:

   • Engineering Specifications and Standards Compliance. For the new features and existing functionalities, the "ground truth" is whether the software performs according to its design specifications, established industry standards (e.g., IEC 60601-1-8 for alarms), and internal quality requirements. For usability, "user feedback" (from focus groups, usability tests) serves as the basis for improvement.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI model that undergoes a "training phase" from a clinical dataset in the traditional machine learning sense. The software development process involves design, coding, and V&V activities.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the same reason as above.

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The intended use of the MX40 is to:

The device is 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.

Indications for Use

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Rx only.

The MX40 is a multi-parameter, battery operated patient monitor that is small enough to be worn by the patient. Its multi-radio design enables device operation within existing Philips telemetry networks while providing compatibility to the IntelliVue Information Center solutions. Along with infrastructure radios, the MX40 integrates a short-range radio (SRR), enabling wireless connectivity to the litelliVue family of monitors. Acquired physiological data, along with physiological alarms and technical alert information are provided to multiple monitoring systems (local, bedsides and /or information systems).

Previously cleared compatible Accessories are still in use, compatibility to additional Massimo accessories are documented in this filing. The MX40 is compatible with the legally marketed Philips CL SpO2 Pod and CL NBP Pod (K101600, K111905). The CL SpO2/NBP Pods are small battery powered devices that measure oxygen saturation, pulse rate and blood pressure, pulse rate, respectively. A list of all accessories is available in the Instructions for Use.

The provided text is a 510(k) summary for the Philips MX40 Release C.01, a physiological patient monitor. It describes the device, its intended use, and a comparison with a predicate device (Philips IntelliVue MX40 Release B.07).

However, this document does not contain the specific information required to answer your request regarding acceptance criteria and the study proving the device meets them.

The document states:

• "No performance standards have been issued under the authority of Section 514."
• "The MX40 Release C.01 was tested in accordance with Philips verification and validation processes."
• "Clinical Performance testing for MX40 Release C.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."
• "Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. 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."

This indicates that the submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing (system level tests, performance tests, and safety testing based on hazard analysis) and adherence to Philips' internal verification and validation processes, rather than conducting a new clinical study with specific acceptance criteria as one might expect for a novel device or a device with new clinical applications.

Therefore, I cannot provide the requested information from this document for the following reasons:

1. A table of acceptance criteria and reported device performance: This document explicitly states that "No performance standards have been issued." While it mentions "Pass/Fail criteria were based on the specifications cleared for the predicate device," these specific criteria and the detailed performance results are not provided in this summary.
2. Sample size used for the test set and data provenance: The document mentions "non-clinical performance testing" and "system level tests, performance tests, and safety testing," but does not specify sample sizes or data provenance (e.g., number of patients, records, or the nature of the test data).
3. Number of experts used to establish ground truth and qualifications: This information would typically be relevant for clinical studies or studies establishing ground truth, which were not performed for this 510(k) as per the document.
4. Adjudication method for the test set: Not applicable as a clinical study for establishing ground truth was not performed.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document clearly states, "Clinical Production testing for MX40 Release C.01 was not performed." Therefore, no MRMC study was conducted.
6. Standalone (algorithm only without human-in-the-loop performance) study: This would typically refer to AI/ML device performance. The MX40 is a physiological monitor, not an AI/ML algorithm in the context typically discussed for standalone performance. Its functions are monitoring and alarm generation for vital parameters. The document focuses on hardware, software, and accessory changes.
7. Type of ground truth used: Not explicitly stated, as clinical performance testing was not performed. The "ground truth" for the non-clinical testing would be the established specifications and expected performance of the predicate device.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) pertains to a modification of an existing physiological monitor, and its acceptance criteria and proof of performance are based on demonstrating substantial equivalence through non-clinical verification and validation against the predicate device's established specifications, rather than a new clinical study with the type of data points you are requesting.

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The intended use of the MX40 is to: The device is 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.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. Rx only.

The MX40 is a multi-parameter, battery operated patient monitor that is small enough to be worn by the patient. Its multi-radio design enables device operation within existing Philips telemetry networks while providing compatibility to the IntelliVue Information Center solutions. Along with infrastructure radios, the MX40 integrates a short-range radio (SRR), enabling wireless connectivity to the IntelliVue family of monitors. Acquired physiological data, along with physiological alarms and technical alert information are provided to multiple monitoring systems (local, bedsides and /or information systems).

The provided document is a 510(k) summary for the Philips MX40 Release B.07, a physiological patient monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI/software component within the device.

Therefore, many of the requested details about acceptance criteria, specific studies proving performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document as it pertains to a modification of an existing device rather than a new device with new clinical claims. Manufacturers typically demonstrate substantial equivalence through verification and validation testing, often against established standards and internal specifications, rather than large-scale clinical trials for minor modifications.

Here's an attempt to answer the questions based on the available information:

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

The document does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity thresholds) or quantitative device performance metrics. Instead, it states:

• Acceptance Criteria (Implied): "Pass/Fail criteria were based on the specifications cleared for the predicate device." (Page 8)
• Reported Device Performance: "test results showed substantial equivalence." (Page 8) and "The MX40 Release B.07 meets all defined reliability requirements and performance claims." (Page 8)

The document lists changes to functionalities, such as:

• Heart Rate Alarm from Pulse, requiring PIC IX version C.01 or higher.
• Auto report battery inop (Technical Alert) when Standby is in low battery state.
• Support CI (Connection Indication) message transport using Unicast protocol for WLAN.
• Malfunc Inop for software license failure - Added self-test to MX40 to allow for confirmation of Software License version to assist users to identify compatibility to other systems.
• Claim IEC60601-1 3rd edition update IFU and Product Labeling appropriately.
• AAMI screen - A new portrait screen 1-wave and 2 numerics to support AAMI EC13 display, local control only & cannot default to this screen from PIC-iX.
• MCS PigTail and Block Adapter hardware to support Respiration measurements.

The "reported device performance" is broadly stated as meeting the specifications of the predicate device.

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

This information is not provided in the document. The document refers to "system level tests, performance tests, and safety testing from hazard analysis" (Page 8), but does not specify sample sizes or data provenance for these non-clinical tests.

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)

This information is not provided in the document, as clinical performance testing, which would typically involve expert ground truth, was not performed.

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

This information is not provided in the document.

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 mentioned or performed, as the device is a physiological monitor and not an AI-assisted diagnostic tool.

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

The document states that "Clinical Performance testing for MX40 Release B.07 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence." (Page 8). Therefore, no standalone clinical performance study was done for this particular submission. The device itself is a standalone physiological monitor, but the nature of the submission (modifications to an existing device) did not necessitate a new standalone performance study against clinical ground truth.

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

For the non-clinical testing performed, the ground truth would have been based on established specifications, standards, and expected performance characteristics of the predicate device and the new functionalities, rather than clinical ground truth like pathology or expert consensus. The changes relate to hardware and software updates, not new diagnostic algorithms requiring clinical validation.

8. The sample size for the training set

This information is not applicable as the document does not describe the development or testing of an AI/machine learning algorithm with a training set. The device is a physiological monitor with specified functionalities.

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

This information is not applicable as there is no mention of an AI/machine learning component or a training set.

Ask a specific question about this device

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

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

The monitor is also intended for use during patient transport inside and outside of the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 EC 11).

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

The IntelliVue Patient Monitors MP2, MP5, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX430, MX450, MX500, MX550, MX600, MX700, MX800 and the Multi-Measurement Module X2 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, Scv02, spirometry, 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. Several monitor models can also be used mobile, during patient transport inside or outside of hospitals.

The monitors have a color display with touch-screen and/or keys and a navigation point as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

The software of the IntelliVue Patient Monitors MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX430, MX450, MX550, MX600, MX700, and MX800, was modified to provide the feature Alarm Advisor. Legally marketed IntelliVue Patient Monitors provide the features Graphic Trends (displays for configurable time in a graphic form patient measurement data to show how this data develops over time) and Alarm Limits window (displays in a graphic form 15 min trends, alarm limits, and measurement values, and allows operator changing the limits manually on the basis of the displayed information).

In the new software Rev. M.0 of the subject devices MP5 to MX800, these functionalities were combined in one feature called Alarm Advisor in order to display in a graphic format for a configurable time trends, alarm limits, and measurement values and to allow operator changing the alarm limits manually.

Compared to Graphic Trends and Alarm Limits window, Alarm Advisor provides two enhancements: it gives feedback in case of recurring or continuous alarm limit violations in form of a notification and it allows operator to try out new alarm limits before setting them, with the help of the graphical trend information. When an operator tries a new alarm limit, Alarm Advisor shows the effect the new alarm limit would have had on the occurred alarm limit violations. The Alarm Advisor itself does not propose any specific alarm limit values. It also does not make any automatic alarm limit settings.

The combination of existing trending and alarm limit setting features and their enhancement joint in the Alarm Advisor feature, supports clinician in adapting alarm limits more specifically for individual patients.

The software of the IntelliVue Patient Monitors MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX430, MX450, MX500, MX550, MX600, MX700, MX800, and the IntelliVue X2 Multi-Measurement Module was additionally modified to support configurable source of QRS tone. In the previously cleared IntelliVue Patient Monitors, the QRS tone can be derived from either HR or Pulse, depending on which is currently selected as the alarm source. In the modified IntelliVue Patient Monitors software Rev. M.0 this limitation has been eliminated so that the source of the QRS tone is free selectable between HR and Pulse.

The provided text describes software modifications to Philips IntelliVue Patient Monitors and the Multi-Measurement Module X2, focusing on the "Alarm Advisor" feature and configurable QRS tone source. The documentation outlines the verification and validation (V&V) activities undertaken to demonstrate the substantial equivalence of these modified devices to their previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study as presented in the document:

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

The document doesn't provide a specific table contrasting acceptance criteria with numerical performance data in the traditional sense of diagnostic accuracy (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicit in the pass/fail criteria of the various tests conducted, and the reported "performance" is that these criteria "have been met."

The primary acceptance criteria seem to be related to:

• Functionality: Correct operation, control, configuration, and functioning of the new features (Alarm Advisor and configurable QRS tone source) as specified and according to labeling claims.
• Safety and Effectiveness: Maintaining safe and effective operation of unchanged functions and adhering to relevant safety standards (e.g., IEC 60601-1-8 for the alarm system).
• Reliability: Meeting all defined reliability requirements and performance claims.

Since specific numerical performance metrics are not given, a table like the one requested cannot be fully constructed. However, we can represent the described V&V outcomes:

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

The document does not specify a "test set" in terms of patient data or case numbers. The V&V activities described are primarily software testing, including functional tests, regression tests, and hazard analysis.

• Sample Size: Not applicable in the context of patient data for performance evaluation in this document. The "sample" would be the software itself and its functionalities.
• Data Provenance: Not applicable as it's not a study on clinical data. The tests were likely conducted on simulated environments or test benches in a laboratory setting by the manufacturer, Philips Medizin Systeme Boeblingen GmbH (Germany).

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

This information is not provided. Since the V&V activities relate to software functionality and technical standards rather than clinical diagnostic performance, the "ground truth" would be established by technical specifications, design documents, and relevant industry standards (e.g., AAMI EC 11 for ECG, IEC 60601-1-8 for alarms). Expert clinical review for establishing a "ground truth" on patient data is not described for these specific software modifications.

4. Adjudication method for the test set:

Not applicable. The V&V activities described are technical tests against predefined internal and external (standards-based) criteria, not clinical case adjudication.

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 device modifications ("Alarm Advisor" and configurable QRS tone) are enhancements to existing monitoring features and do not describe an AI component that would assist human readers in interpretation or diagnosis. The Alarm Advisor
"supports clinicians in adapting alarm limits more specifically for individual patients" by providing graphical trend information and allowing "trying out" new alarm limits, but it "does not propose any specific alarm limit values" nor "make any automatic alarm limit settings." Therefore, it's not an AI-assisted diagnostic tool as typically evaluated by MRMC studies.

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

No, a standalone algorithm-only performance study was not done for a diagnostic algorithm. The Alarm Advisor and configurable QRS tone are integrated software features of a patient monitor, and their performance is evaluated in the context of their functional correctness and compliance with specifications, not as a standalone diagnostic algorithm.

7. The type of ground truth used:

The ground truth for the V&V activities was based on:

• Technical Specifications: Internal design documents and functional requirements for the software features.
• Industry Standards:
  • AAMI EC 11 for ECG measurement (mentioned in the Indications for Use for various monitor models).
  • IEC 60601-1-8 for the alarm system (specifically mentioned for regression tests of the alarm system).
• Hazard Analysis: Ensuring risks are mitigated as per established safety protocols.
• Predicate Device Performance: Pass/fail criteria were based on specifications cleared for the predicate devices, ensuring substantial equivalence.

8. The sample size for the training set:

Not applicable. This document describes V&V activities for software modifications to existing patient monitors, not the development or training of an AI algorithm from a dataset.

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

Not applicable, as there is no mention of a training set for an AI algorithm.

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The Infinity Delta Series Monitor (Delta/Delta XL/Kappa) are capable of

• monitoring:
• · Heart rate
• · Respiration rate
• · Invasive pressure
• · Non-invasive pressure
• · Arrhythmia
• · Temperature
• · Cardiac output
• · Arterial oxygen saturation
• · Pulse rate
• · Apnea
• · ST Segment Analysis
• 12-Lead ST Segment Analysis
• · tcp02/tcpC02
• · EEG signals
• · FiO2
• etCO2
• · Respiratory mechanics
• · Anesthetic agents
• · Neuromuscular transmission

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians. Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Infinity Delta Series (Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arthythmia which are intended for use in the adult and pediations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.

For combination with Scio gas module:

Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.

Infinity Delta and Kappa Series Monitors (Delta XL/ Kappa) are multi-parameter patient monitors intended for use at the patient bedside for the collection of physiological data. The intent of this 510(k) is to describe the proposed software and hardware modifications to the Infinity Delta and Kappa Series Monitors version VF9.1 which includes the integration of an alternative etCO2 solution for the Delta and Delta XL patient monitors as well as software enhancements for the Delta, Delta XL and Kappa patient monitors.

The provided text is a 510(k) summary for the Infinity Delta, Infinity Delta XL, and Infinity Kappa patient monitors. It describes software and hardware modifications to the existing devices, primarily the integration of an alternative etCO2 solution. However, it does not contain a study that proves the device meets specific acceptance criteria with detailed performance metrics, sample sizes, or ground truth establishment.

Instead, the summary states:

• "The substantial equivalence was assessed via internal verification tests, validation evaluations and external tests to FDA recognized consensus standards."
• "Performance data related to each proposed modification has been tested and evaluated."
• "High level summary reports are included in this special 510k demonstrate the changes to the monitors are substantially equivalent to the predicate devices."
• "The modified Infinity Delta and Kappa Series Monitors have been tested in accordance with applicable standards and internal design control procedures and were determined to be as safe and effective as the predicate device for its intended use."

This indicates that testing was performed, but the details of those tests, including specific acceptance criteria and detailed performance results, are not present in this document. The document focuses on demonstrating substantial equivalence to a predicate device (K070566) rather than providing a detailed performance study against specific acceptance criteria for a novel device.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, or adjudication methods from the provided text. The document asserts that testing was done to ensure substantial equivalence, but it does not present the results of such testing in the format you've requested.

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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 and recording 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 MP40/MP50 monitors are additionally intended for use in transport situations within hospital environments. The monitors are only for use on one patient at a time. 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 EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. 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 transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. 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 pediatric 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 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 subject devices Philips IntelliVue Patient Monitor family comprises the multiparameter patient monitor models: Intelli Vue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX500, MX50, MX600, MX700, MX800 that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. The monitors acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. 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. The monitors can also be used mobile, during patient transport in a hospital setting. The measurement sensors of the connected external measurement modules are applied at diverse bodily locations, depending on the actual physiological parameters monitored, e.g. on a patient's finger for the pulse oximetry or on a patient's upper arm for the non-invasive blood pressure. The monitors have a color display with touch-screen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. One external display, which provides an adaptive duplicate image of the primary display, can be connected to a built-in video port. The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link. The subject modification extends the capability of IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX500, MX550, MX600, MX700, MX800 by: - G7m Gas Analyzer (866173) . The legally marketed G5 Gas Analyzer Module (M1019A) used together with the IntelliVue Patient Monitors MP40 - MP90 and MX500-MX800 has been re-designed to create the new G7m Gas Analyzer Module (866173) intended for use with the Intelli Vue Patient Monitors MP40 - MP90 and MX500-MX800. When connected to a patient monitor, the G7m Gas Analyzer Module (866173) acquires airway gases of intubated patients and measures continuously carbon dioxide (CO2), oxygen (02), nitrous oxide (N20), and up to two of the automatically identified anesthetic agents Enflurane (ENF), Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV) or Desflurane (DES), and calculates the respiration rate. The IntelliVue Patient Monitors MP40 - MP90 and MX500-MX800 have additionally been modified to support the new G7m Gas Analyzer Module (866173). The modification for this purpose is limited to a minor software changes in the AGM/EGM Application Software Module (ASW). Additionally the software revision L.03 is made available for the entire IntelliVue Patient Monitors family.

The Philips IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, and MX800 with software revision L.03, and the new G7m Gas Analyzer Module (866173) underwent various verification and validation activities to demonstrate their performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device were based on various recognized consensus standards and the performance specifications cleared for the predicate devices. The document does not provide a specific table of acceptance criteria with numerical thresholds. Instead, it broadly states that "All specified pass/fail criteria have been met" and "The test results confirmed the effectiveness of the implemented design risk mitigation measures."

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

The document does not specify exact sample sizes for the test sets in any of the V&V activities. It refers to "host devices IntelliVue -Patient Monitors MP40 to MP90, and MX500 to MX800" for EMC testing and "host devices IntelliVue Patient Monitors" for safety and performance testing of the G7m module. No information is provided regarding the country of origin of the data or whether the studies were retrospective or prospective.

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

The document does not provide information about the number or qualifications of experts used to establish ground truth for any of the V&V activities. The tests primarily focus on engineering and compliance aspects rather than clinical expert consensus.

4. Adjudication Method for the Test Set

No adjudication method is described. The V&V activities appear to be based on objective measurements against predefined technical specifications and standards rather than subjective expert review.

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

No MRMC comparative effectiveness study was mentioned. The documentation focuses on testing the device's adherence to technical standards and its functional performance, not on direct comparison of human reader performance with and without AI assistance. The device is a patient monitor, not an AI diagnostic tool that assists human readers in interpreting complex images or data.

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

The studies described are inherently "standalone" in the sense that they evaluate the device's technical performance, safety, and functionality according to engineering standards. The focus is on the monitor's ability to accurately acquire, display, and alarm for physiological parameters, and the gas analyzer's ability to measure gases, independent of human interpretation of raw data for diagnosis. Thus, the V&V activities effectively serve as a standalone performance assessment within their scope.

7. Type of Ground Truth Used

The ground truth for the verification and validation activities was primarily based on:

• Recognized consensus standards: IEC 60601-1-2:2007 (EMC), ANSI/AAMI ES60601:2005 +A1:2012 / IEC 60601:2005 +A1:2012 (Safety), ISO 80601-2-55:2011 (Gas analyzer safety), IEC TR60721-4-7 series and IEC 60068-2-xx series (Mechanical), and IEC 62304:2006 (Software life cycle).
• Specifications cleared for the predicate devices: Performance claims and pass/fail criteria for the modified devices were benchmarked against those of previously cleared Philips IntelliVue Patient Monitors.
• Design risk mitigation measures: Effectiveness of these measures was confirmed through hazard analysis tests.

8. Sample Size for the Training Set

No training set is mentioned as this device is a patient physiological monitor and gas analyzer. It does not appear to involve machine learning or AI models that require a separate training set. The "modification for this purpose is limited to a minor software changes in the AGM/EGM Application Software Module (ASW)," suggesting traditional software development and testing.

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

Not applicable, as no training set was used.

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The Philips IntelliVue MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX450, MX500, MX550, MX600, MX700 and MX800 patient monitors with software revision L.02 and the Philips IntelliVue X1(M3001AL) and X2 Multi-Measurement Module with software revision L.02 are indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

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

The MP2 and X2 are also intended for use during patient transport inside of the hospital environment. The MP5, MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MX400/MX450/MX550 are additionally intended for use in transport situations within hospital environments. The MP20/MP30/MP40/MP50 monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. 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 EC 11).

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

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 transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

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 pediatric 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 Protocol Watch clinical decision support tool, is intended for use with adult patients only.

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 Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

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 with patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The subject devices Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: IntelliVue Patient Monitors MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX400, MX450, MX500, MX550, MX600, MX700, MX800 and IntelliVue X1(M3001AL) and X2 Multi-Measurement Module that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules.

The monitors acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The monitors offer a monitoring solution optimized for the surgical, cardical and neonatal care environments. They are located in the patient vicinity at the bedside. The monitors can also be used mobile, during patient transport in a hospital setting.

The measurement sensors of the connected external measurement modules are applied at diverse bodily locations, depending on the actual physiological parameters monitored, e.g. on a patient's finger for the pulse oximetry or on a patient's upper arm for the non-invasive blood pressure.

The monitors have a color display with touch-screen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. One external display, which provides an adaptive duplicate image of the primary display, can be connected to a built-in video port.

The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

The subject modification introduces the Masimo rainbow SET® technology as a further SpO2 option for the Philips IntelliVue MP2 and MP5/MP5SC Patient Monitor and for the Philips IntelliVue X1(M3001AL) and X2 Multi-Measurement Modules.

Additionally the software revision L.02 is made available for the entire IntelliVue Patient Monitors family.

This is a Philips IntelliVue Patient Monitoring System (Multiple Models) (K150975).

Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance standards that the device was verified against, indicating that meeting these standards served as the acceptance criteria. The document states that all specified pass/fail criteria have been met.

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

The document does not explicitly state the sample size (number of patients or data points) used for the test set(s). It mentions "testing involved system level and as well as testing from the hazard analysis." It also indicates that "Pass/Fail criteria were based on the specifications cleared for the predicate devices."

The data provenance (e.g., country of origin, retrospective or prospective) for the test sets is not specified in the provided text. The testing seems to be focused on meeting technical standards rather than involving clinical performance with patient data explicitly described in this section.

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

This information is not provided in the document. The testing described appears to be primarily technical verification and validation against established engineering and safety standards, rather than clinical outcome-based ground truth established by medical experts for a comparative study.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the testing described (compliance with standards, hazard analysis), an adjudication method for a test set in the traditional sense of clinical data interpretation by experts is unlikely to have been part of these specific tests.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The submission focuses on device modifications and their compliance with safety and performance standards for substantial equivalence, not on comparing reader performance with or without the device's AI capabilities.

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

While the overall device includes software and algorithms, the studies described are for system-level verification and validation. There isn't an explicit standalone performance study of a particular algorithm described in the provided text that would assess its performance independent of the human user. The performance is assessed in the context of the entire patient monitoring system meeting established standards.

7. Type of Ground Truth Used

The "ground truth" for the tests appears to be defined by:

• Established engineering and safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-49, ISO 80601-2-61, IEC 62304.
• Specifications cleared for predicate devices: "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
• Hazard analysis: Ensuring the effectiveness of risk mitigation measures.

There's no mention of ground truth established by expert consensus, pathology, or direct outcomes data in the context of the verification and validation activities described.

8. Sample Size for the Training Set

This information is not provided. The document describes software verification and validation, but it does not detail any machine learning or AI models that would require a distinct "training set." The software is being updated (revision L.02), and a new SpO2 technology (Masimo rainbow SET) is being integrated, but the details of any related training data are absent.

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

Since no specific "training set" for an AI model is mentioned or described, the method for establishing its ground truth is not applicable/provided in this document.

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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 and recording 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 additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. 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.

The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. 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 subject devices Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The specific models differ in the size of their flat panel displays and in the number of supported external measurement modules.

MX400 has a 9" display, MX450 and MX500 have a 12" display and MX550 has a 15" display. In addition to the MX400 and MX450, the MX500 and MX550 models have three integrated slots for use with the dedicated external plug-in modules.

The monitors do not have any built-in measurements. They are intended to be connected to any one of the external IntelliVue family physiological multi-measurement modules and/or (MX500/MX550 only) to the IntelliVue plug-in measurement modules.

The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, C.O., CCO, intravascular SO2, spirometry, EEG, gas measurements, and NMT. The interaction with the patient depends on the monitored physiological parameter(s).

The monitors acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

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. The monitors can also be used mobile, during patient transport in a hospital setting.

The measurement sensors of the connected external measurement modules are applied at diverse bodily locations, depending on the actual physiological parameters monitored, e.g. on a patient's finger for the pulse oximetry or on a patient's upper arm for the non-invasive blood pressure.

The monitors have a color display with touch-screen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. One external display, which provides an adaptive duplicate image of the primary display, can be connected to a built-in video port.

The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

The modification, which is subject of this Premarket Notification, enables the IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 via software update to support two additional features: Remote Display application and Remote Applications, The Remote Display application feature provides the possibility to view an independent monitor screen on an external display and to operate patient monitor from the external display.

The Remote Applications feature allows the user of the patient monitor to access remotely hosted, pre-configured applications made available by the hospital.

The added functionalities are the same as those already provided by other legally marketed Philips IntelliVue Patient Monitors, such as predicate model MX800. For access to the Remote Applications, the predicate Intelli Vue Patient Monitor MX800 supports commercial application server technology, whereas the modified IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 support commercial application server technology as well as the HTML5 protocol for compatibility with standard web application servers

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitors MX400, MX450, MX500, and MX550, based on the provided 510(k) summary:

This submission describes a software update to existing patient monitors, adding "Remote Display application" and "Remote Applications" features. Therefore, the V&V activities primarily focus on confirming the correct functioning of these new software features and ensuring that previously cleared functionalities are not negatively impacted.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is a software update for existing devices, the "acceptance criteria" are primarily related to the successful implementation and verification of the new features and the continued performance of existing features. The document highlights the meeting of existing specifications and "pass/fail criteria" from previous clearances.

• Correct presentation of parameter data on the Remote Display.
• Correct presentation of alarm and/or INOP information on the Remote Display.
• Correct presentation of operating windows on the Remote Display.
• Ability to operate patient monitors from the Remote Display.
  Remote Applications:
• Correct display of remote applications on the monitor screen.
• Operability of remote applications with user input devices. | Remote Display Application:
  "The conducted tests demonstrate that parameter data, alarm and/ or INOP information and operating windows provided by the modified patient monitors are correctly presented on the Remote Display and that the patient monitors can be operated from the Remote Display."
  Remote Applications:
  "The conducted tests demonstrate that the remote applications are correctly shown on the display of the modified patient monitors and can be operated with user input devices." |
  | Safety & Risk Mitigation | - All specified pass/fail criteria from Hazard Analysis met.
• Effectiveness of implemented design risk mitigation measures. | "All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures." |
  | Regression/Non-Interference | Unchanged and unaffected functions from the previous software (Rev. K.10) continue to work correctly with the new software (Rev. K.20).
• Safe, effective, and correct operation according to all specifications and labeling claims of the predicate devices. | "The regression tests demonstrate that the modified patient monitors work safely, effectively, and correctly in accordance with all specifications and labeling claims."
  "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." |
  | General Reliability & Performance | Meeting all defined reliability requirements and performance claims. | "The results demonstrate that the Philips Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 meet all defined reliability requirements and performance claims." |

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

The document does not explicitly state the "sample size" in terms of number of patients or cases for clinical data. Instead, the testing is described as functional and regression testing on the physical devices (monitors).

• Sample Size: Not applicable in the context of clinical patient data. The "sample" would be the specific hardware models (MX400, MX450, MX500, MX550) with the updated software (Rev. K.20). The tests were conducted on these devices.
• Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing was an internal validation and verification (V&V) activity.

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

Not applicable. The ground truth for this type of V&V (functional and regression testing of software features on a patient monitor) is the expected behavior and output of the device as defined by its specifications and design documents. It does not involve expert clinical assessment of patient data.

4. Adjudication Method for the Test Set

Not applicable. This was internal engineering and software testing against predefined functional and non-functional requirements and previous device specifications. It does not involve adjudication of clinical findings.

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 submission is for a software update to a patient monitor, adding features for remote display and remote application access. It does not involve an AI component for interpretation or diagnosis, nor does it involve human readers assessing cases.

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

Not applicable. The device is a patient monitor, which continuously collects and displays physiological parameters. The new features (Remote Display and Remote Applications) are functionalities that enhance how users interact with and access data from the monitor. There isn't a standalone "algorithm" in the diagnostic or interpretative sense tested separately.

7. The Type of Ground Truth Used

The ground truth used for this V&V was based on:

• Device Specifications: The pre-defined expected outputs and behaviors of the patient monitor and its new features.
• Predicate Device Performance: The established performance and specifications of the previously cleared IntelliVue Patient Monitors (Rev. K.10 and MX800 models).
• Hazard Analysis Requirements: Safety criteria and risk mitigation effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a training set of data. The "training" for the software involves its development, coding, and internal debugging processes, not a dataset in a machine learning context.

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

Not applicable, as there is no training set in the machine learning sense.

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