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The Philips IntelliSpace Perinatal Obsterical Information Management System is indicated for obsterior and after pregnancy, who require monitoring in a healthcare setting.

The Philips IntelliSpace Perinatal system provides:

• Basic and advanced fetal trace alarming for both antepartum and intrapartum patients.
• Central monitoring of maternal alarming.
• Documentation capabilities and data storage.
• Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility Remote Desktop Session (RDS).
• An interface to launch the Philips IntelliVue XDS Remote viewing and operating of compatible patient monitors.

The Philips IntelliSpace Perinatal Rev. K.00 is a patient-oriented, departmental information management system for the obstetrical care environment. It covers OB care in so far as it is relevant for GYN visits, pregnancy, labor, birth and newborn documentation. It combines surveillance and alarming with comprehensive patient documentation and data storage into one system that covers the continuum of obstetrical care across one or more pregnancies, from the first antepartum visit until delivery and discharge.

The provided document is a 510(k) summary for the Philips IntelliSpace Perinatal Revision K.00. This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

However, it does not contain details about specific acceptance criteria related to a performance study (e.g., accuracy, sensitivity, specificity) for an AI/ML-based device. The document primarily focuses on non-clinical verification and validation (V&V) activities for software modifications and does not describe a clinical performance study with human readers or an algorithm-only standalone performance study.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text. The information given is at a higher level, focusing on regulatory compliance for a software system that manages obstetrical information and integrates with other monitoring devices, rather than a diagnostic AI algorithm with quantifiable performance metrics.

Here is what I can extract and infer based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• The document states that "All specified pass/fail criteria have been met" for the nonclinical V&V activities. However, it does not specify what those exact performance criteria are in terms of numerical metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML component. The "performance" described is about the functionality and safety of the software modification, not a diagnostic accuracy metric.

  Acceptance Criterion Type	Specific Criterion (If available in document)	Reported Device Performance (If available in document)
  Functionality	Correctly hand over start-up parameters to XDS software	Met: "conducted tests demonstrate that start-up parameters provided by the modified IntelliSpace Perinatal software are correctly handed over to the XDS software"
  	Correct operation of patient monitors via XDS	Met: "compatible IntelliVue patient monitors can be correctly operated via the XDS software."
  Safety	Effectiveness of implemented risk mitigation measures	Met: "Test results confirmed the effectiveness of implemented risk mitigation measures."
  General V&V	All specified pass/fail criteria	Met: "All specified pass/fail criteria have been met."

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

• Sample Size: Not explicitly stated as this was a software engineering V&V activity, not a clinical trial or performance study on a specific dataset. The tests were likely performed on a simulated environment or
  test cases designed to validate software functionality.
• Data Provenance: Not applicable in the context of a "test set" for an AI/ML performance study. The testing was of the software's functionality and safety, not its diagnostic accuracy on 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. The document describes software verification and validation, which typically involves software engineers and quality assurance professionals, not clinical experts establishing ground truth for diagnostic outputs.

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

• Not applicable. As no clinical ground truth was established by experts for a test set, no adjudication method was mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was performed or described. The document explicitly states: "Therefore, a clinical study was not needed for the changes provided with the Philips IntelliSpace Perinatal Obstetrical Information Management System software revision Rev.K.00." The modifications were software updates related to integration and data management, not an AI assisting human readers in diagnosis.

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

• No standalone algorithm performance study was performed or described. The device is a perinatal information management system, not a standalone diagnostic AI algorithm. Its function is to provide "Basic and advanced fetal trace alarming," "Central monitoring of maternal alarming," and "Documentation capabilities and data storage." These are system functions, not typically evaluated as a "standalone algorithm" in the same way a diagnostic AI would be. The closest described is functional testing of the software's ability to hand off data and control.

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

• Not applicable. The ground truth in this context refers to the expected behavior and output of the software functions as defined by the system requirements and design specifications, not clinical markers. This is a V&V process for software, where "ground truth" would be software specifications and expected functional outcomes.

8. The sample size for the training set:

• Not applicable. The document describes the V&V of a non-AI software system; there is no mention of a training set as would be found with an AI/ML model.

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

• Not applicable, as no training set was used or mentioned.

Summary of what the document does convey regarding validation:

• The modifications to the Philips IntelliSpace Perinatal system (Revision K.00) are primarily software-based, focusing on:
  • Launching the Philips IntelliVue XDS Application for remote access to patient monitors.
  • Adapting web TS client resolution for mobile devices.
  • Adding configurable columns to electronic chalkboards.
  • Providing additional options for documentation and reporting.
  • HL7-based interfacing with ADT systems.
  • Updating Windows Server compatibility.
  • Adding more supported HL7-IHE profiles.
  • Introducing roles and permission-based patient data access control.
  • Adjusting alarm sound pressure levels.
  • Adjusting system scalability (fetal monitors and client sessions).
• Nonclinical V&V activities were performed:
  • Safety and Performance testing according to ANSI/AAMI/IEC 62304:2006.
  • Tests required by Hazard Analysis.
  • Functional tests of the modified software, including the new XDS launch feature, based on FDA guidance for software in medical devices.
  • The software was categorized as having a "MAJOR" level of concern.
• Conclusion from V&V: The tests demonstrated that start-up parameters are correctly handed over to XDS, and patient monitors can be operated via XDS. All pass/fail criteria were met.
• Clinical Data: "a clinical study was not needed" because the "similarities and differences... were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios."

In essence, this document is a regulatory submission for a software update to an existing information management system, not a submission for a novel AI/ML diagnostic tool requiring a performance study against a clinical ground truth.

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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 Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. 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 Philips IntelliVue Patient Monitors family comprises the multiparameter patient monitor series: MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, and MX800. Each monitor consists of a display unit including built-in or separate central processing unit (CPU) and physiological measurement modules. All monitors share the same architecture of CPU units and exactly the same software is executed on each monitor. The monitors measure physiological parameters such as: Sp02, pulse, ECG, arrhythmia, ST, QT, respiration, invasive and noninvasive blood pressure, temperature, CO2, spirometry, C.O., CCO, tcp02/ tcpCO2, S02, Sv02, Scv02, EEG, and BIS. They generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to the central station. IntelliVue series MP2, X2, MP5, MP5T, MP5SC, MP20, and MP30 are robust, portable, lightweight, compact in size and modular in design patient monitors with interfaces to dedicated external measurement devices. Models MP2, X2, MP5, MP5T, and MP5SC also incorporate multiple built-in physiological measurements. IntelliVue series MP40, MP50, MP60, MP70, MX600, MX700, and MX800 are patient monitors with built-in central processing unit, flat panel display and interfaces to dedicated external measurement devices. Models MX600, MX700, and MX800 have widescreen displays. IntelliVue series MP80 and MP90 are patient monitors with flat panel display and central processing unit as separate components. They have interfaces to dedicated external measurement devices.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured as requested:

Acceptance Criteria and Device Performance Study for Philips IntelliVue Patient Monitors (Software Revision J.04)

Overview:
The submission describes a software modification to existing Philips IntelliVue Patient Monitors (MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700, and MX800) to introduce a new SpO2 intelligent alarm delay feature called 'Smart Alarm Delay'. The study aims to demonstrate that this modified device is as safe and effective as the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a quantitative table of acceptance criteria with corresponding performance metrics for the 'Smart Alarm Delay' feature in the format often seen for diagnostic devices (e.g., sensitivity, specificity, accuracy). However, the "Summary of V&V activities" section outlines the general performance goals and outcomes.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not specify the exact number of individuals (test persons) involved in the clinical evaluation. It refers to "two user groups - one consisting of physicians and one consisting of nurses" and later "the vast majority of test persons." This suggests a qualitative assessment rather than a statistically powered performance study.
• Data Provenance: Not explicitly stated, but clinical evaluation of user understanding implies prospective testing with healthcare professionals. The country of origin for this specific clinical evaluation is not mentioned.

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

• The "clinical evaluation" appears to focus on user comprehension and acceptance, not on establishing a traditional clinical "ground truth" for diagnostic accuracy.
• Number of Experts: Two user groups were formed: "one consisting of physicians and one consisting of nurses." The exact number of individuals within each group is not provided.
• Qualifications of Experts:
  • Physicians
  • Nurses
  • No specific years of experience or subspecialty are mentioned.

4. Adjudication Method for the Test Set

Not applicable. The clinical evaluation described is a qualitative assessment of user understanding and perception, not a diagnostic accuracy study requiring adjudication of results.

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

No. The document describes a software modification to an existing patient monitor to add an intelligent alarm delay feature. The "clinical evaluation" focused on user understanding and acceptance of this feature, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, not in the traditional sense of a standalone diagnostic algorithm performance study. The modification is an alarm delay feature within an existing monitoring system. The document states:

• "The new 'Smart Alarm Delay' feature is isolated from the SpO2 measurement algorithm, i.e. signal acquisition and numeric processing."
• "The devices hardware and all accessories including, but not limited to the SpO2 sensors remain completely unchanged."
• "The modification does not affect device performance in general and device accuracy in particular."
• Performance aspects covered by ISO 9919 from prior V&V are considered still valid.

This indicates that the fundamental SpO2 measurement accuracy itself was not re-evaluated as a standalone algorithm performance, as the algorithm for SpO2 measurement remained unchanged. The focus was on the alarm delay logic and its user-facing implications.

7. Type of Ground Truth Used

For the "clinical evaluation" regarding the 'Smart Alarm Delay' feature, the "ground truth" appears to be user understanding and subjective opinion as gathered directly from physicians and nurses. For the core SpO2 measurement, the ground truth and performance validation are based on prior verification and validation activities conducted according to ISO 9919 for the predicate device, which are deemed still valid.

8. Sample Size for the Training Set

Not applicable. This submission is for a software modification adding an alarm delay feature, not a machine learning or AI algorithm that requires a dedicated training set for model development. The 'Smart Alarm Delay' is described as being "based on the same fundamental principle" as the predicate's 'SatSeconds' alarm management technique, implying a rule-based or empirically derived logic rather than a learned model.

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

Not applicable, as no training set for a machine learning model was described or used.

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IntelliVue Guardian Software:
The IntelliVue Guardian Software is indicated for use by healthcare providers whenever there is a need for generation of a patient record.
The IntelliVue Guardian Software is intended for use in the collection, storage and management of data from IntelliVue Cableless Measurements and IntelliVue Patient Monitors that are connected through networks.

IntelliVue CL SpO2 Pod:
The IntelliVue CL SpO2 Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters Sp02 and pulse rate wirelessly.
The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, recording, and alarming of arterial oxygen saturation and pulse rate of adult and pediatric patients.
The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxyger saturation and pulse rate data of adult and pediatric patients for a clinical information management system.
The IntelliVue CL SpO2 Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.

IntelliVue CL NBP Pod:
The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters non-invasive blood pressure and pulse rate wirelessly.
The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, recording, and alarming of systolic, diastvlir, and mean pressure and pulse rate of adult and pediatric, patients.
The IntelliVue CL NBP Pod is also intended for acquisition of systolic, diastolic, and mean pressure and pulse rate data of adult and pediatric patients for a clinical information management system.
The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.

New IntelliVue Guardian Software:
The new IntelliVue Guardian Software is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue patient monitors. The Guardian Software provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing.
The IntelliVue Guardian Software is software only product intended to be installed on a customer supplied PC or Server.

Modified IntelliVue CL SpO2 Pod:
The IntelliVue CL SpO2 Pod is a small, battery powered, wrist worn pulse oximeter device. It contains Philips FAST-Sp02 (Fourier Artifact Suppression Technology) to provide reliable saturation values under various artifact conditions including motion and low perfusion. It provides continuous cperating mode and intermittent operating mode with configurable measuring me intervals. Integrated monochrome LCD display shows measured values, measurement signal quality, battery state, and RF signal strength. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable SpO2 sensors.
The IntelliVue CL Sp02 Pod remains unchanged as it is. The modification, which is subject of this Premarket Notification, is solely limited to the labeling change in order to indicate the usage of this device together with the new Philips IntelliVue Guardian Software.

Modified IntelliVue CL NBP Pod:
The IntelliVue CL NBP Pod is a small, battery powered, noninvasive blood pressure and pulse rate measurement device. It uses oscillometric method for measuring NBP. It produces numerics for systolic, diastolic and mean blood pressure values and pulse rate. Integrated monochrome LCD Display shows measured values, battery state, and RF signal strength. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable NBP cuffs.
The IntelliVue CL NBP Pod remains unchanged as it is. The modification, which is subject of this Premarket Notification, is limited to the labeling change in order to indicate the usage of this device together with the new Philips IntelliVue Guardian Software.

The provided 510(k) summary describes the IntelliVue Guardian Software and modified IntelliVue CL SpO2 Pod and CL NBP Pod. However, it does not contain the specific details required to fully address all aspects of your request regarding acceptance criteria and a detailed study proving the device meets those criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the device successfully met its specifications and performed reliably. Specific, quantifiable acceptance criteria (e.g., specific accuracy metrics for data collection, thresholds for system response times) and their corresponding reported performance values are not explicitly provided in this summary. The "performance" is described in general terms of functionality and clinical usefulness.

2. Sample Size for the Test Set and Data Provenance

The summary does not specify a sample size for any test set (e.g., number of patients, number of data points, or number of simulated scenarios).

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective/Prospective: Not specified for the performance tests, but the "Clinical Evaluation" implies prospective use in a clinical setting to assess usefulness and acceptance by users.

3. Number of Experts and Qualifications for Ground Truth

The summary mentions "clinical users" in the context of the "Clinical Evaluation" for user acceptance. However, it does not specify the number of experts, their qualifications (e.g., radiologists with X years of experience), or their role in establishing ground truth for any performance metrics. The ground truth for this device appears to be primarily related to system functionality and user acceptance, rather than a diagnostic output requiring expert consensus.

4. Adjudication Method

The summary does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set or for establishing ground truth.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a Clinical Information Management System and cableless measurement pods, which are generally not subject to MRMC studies in the same way an AI-powered diagnostic tool would be. The focus is on data collection, management, and display.

6. Standalone Performance Study

The summary mentions "Non-Clinical Performance Tests (bench testing)" and "Functionality testing on the new IntelliVue Guardian Software," which imply standalone or algorithm-only evaluation of the software and its components. However, it does not provide specific metrics or results from such a standalone study beyond a general statement of "confirmed static and dynamic performance... according to the specifications."

7. Type of Ground Truth Used

The "ground truth" for the various tests appears to be established as follows:

• Non-Clinical Performance Tests: Adherence to "specifications" for static and dynamic performance. This likely refers to predefined technical requirements and expected system behavior.
• Clinical Evaluation: "Clinical usefulness" and "acceptance by the clinical users." This suggests a qualitative assessment based on user feedback and observation in a clinical setting.
• Functionality Testing: Verification against expected functional behavior of the software and hardware components.

There is no mention of pathology, expert consensus on diagnostic outcomes, or long-term outcomes data as ground truth, as these would typically apply to diagnostic or prognostic devices.

8. Sample Size for the Training Set

This document describes a clinical information management system and monitoring devices. It does not explicitly mention a training set in the context of machine learning or AI. The product is not presented as an AI/ML device that requires a training set in the conventional sense. The "IntelliVue Guardian Software" is described as a "Software only product," and its features like "Early Warning Scoring capability" sound like rules-based algorithms rather than learned models.

9. How Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned for an AI/ML model, the question of how its ground truth was established is not applicable based on the provided text.

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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, pediatrics and neonates in hospital environments. The MP5 is also intended for use in transport situations within and outside of hospital environments.

The Philips IntelliVue MP5 Patient Monitor is a device for monitoring and recording of and to generate alarms for, multiple physiological parameters. The modification is the introduction of software release G.1.

Here's a summary of the acceptance criteria and study information based on the provided text for the Philips IntelliVue MP5 Patient Monitor:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing quantitative acceptance criteria and corresponding reported device performance metrics. Instead, it states:

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "Verification, validation, and testing activities."

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

The document does not provide information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size for human readers improving with or without AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone (Algorithm Only) Performance Study

The document describes "system level and regression tests as well as testing from the hazard analysis" to establish performance, functionality, and reliability. This implies standalone testing of the software (algorithm only) as part of the system, but specific details or dedicated "standalone study" results are not provided beyond the general statement of meeting requirements.

7. Type of Ground Truth Used

The document implies that the ground truth for testing was based on "specifications cleared for the predicate device" and "reliability requirements and performance claims." This suggests internal engineering specifications and expected performance, rather than external expert consensus, pathology, or outcomes data in a clinical trial sense.

8. Sample Size for the Training Set

The document does not mention any training set or its sample size. This is a software update for a patient monitor, and the testing described focuses on verification and validation against established specifications, not on an AI model that requires a distinct training phase.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

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