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The IntelliVue GuardianSoftware is indicated for use by healthcare providers whenever there is a need for the generation of a patient record.

The IntelliVue GuardianSoftware is intended for use in the collection, storage and management of data from Philips Cableless Measurements and Philips Patient Monitors that are connected through networks.

The IntelliVue GuardianSoftware (866009) is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue Patient Monitors. The IntelliVue GuardianSoftware provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing. The IntelliVue GuardianSoftware only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.

The IntelliVue GuardianSoftware can currently acquire physiological data from the following compatible measuring devices:

• Philips IntelliVue Measurements CL SpO2 Pod, CL NBP Pod, CL Resp Pod and l
• Philips IntelliVue Patient Monitors MP5 and MP5SC. -

The subject modification adds the Philips IntelliVue MX400/450 patient monitors and the Philips Suresigns VS3/VS4 patient monitors as additional optional Philips patient monitors to the list of measuring devices compatible with the IntelliVue GuardianSoftware and updates the versions of the supported SQL database versions.

To support the before described purposes the IntelliVue GuardianSoftware was modified to maintain a consistent numbering scheme. The modified common software revision is Rev.C.0

The provided document pertains to an FDA 510(k) premarket notification for the Philips IntelliVue Guardian Software Revision C.0, which is a Clinical Information Management System. However, the document does not contain specific details regarding acceptance criteria, reported device performance metrics, or the study used to prove the device meets such criteria.

The document focuses on:

• Administrative changes: Updating a previous SE determination letter to remove a secondary product code.
• Description of the device: Stating that the IntelliVue GuardianSoftware collects and manages vital signs data from Philips Cableless Measurements and IntelliVue Patient Monitors. It provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories (including EWS deterioration status), remote viewing and operating, interfacing, storage, and printing.
• Modifications: The subject modification adds Philips IntelliVue MX400/450 and Philips Suresigns VS3/VS4 patient monitors as compatible devices and updates supported SQL database versions.
• Technological characteristics: Stating that the modified device has the same technological characteristics as the predicate device (software-only, client-server architecture, runs on standard PC/Server with specified Microsoft OS and databases).
• Verification, Validation, and Testing: A general statement about software functional testing, regression testing, and hazard analysis testing, confirming that pass/fail criteria were met. It also mentions compliance with IEC 62304:2006 for software life cycle processes.

Therefore, I cannot provide the requested information. The document explicitly states: "The 510(k) submission was not re-reviewed" (page 0), and "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject modified devices with respect to the predicate. Testing involved software functional testing and regression testing on an integration and system level as well as testing from the hazard analysis." (page 6). It also states: "Pass/Fail criteria were based on the specifications cleared for the predicate devices and all test results showed substantial equivalence." (page 6).

This indicates that clinical performance data, specific acceptance criteria, or detailed study results are not included in this summary. The focus is on demonstrating substantial equivalence to a predicate device through software verification and validation, rather than proving performance against new, explicit acceptance criteria with detailed study data.

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Avalon Fetal/Maternal Monitor FM20:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM30:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal/Maternal Monitor FM50:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The legally marketed Philips Avalon fetal/maternal monitors FM20. FM30. FM40. and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal electrocardiography (ECG) wave, maternal noninvasive blood pressure (NIBP), oxygen saturation (SpO2) with pulse rate and temperature, during antepartum testing and labor and delivery.

The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
• Fetal Movement Profile -
• Uterine activity via external Toco -
• -Maternal nulse rate
• -Maternal Heart Rate via maternal ECG
• Noninvasive blood pressure (NBP) -
• Maternal temperature -
• Pulse oximetry (maternal SpO2) -

The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:

• One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
• -Uterine activity via intrauterine pressure (IUP)
• -Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
• Fetal Movement Profile -
• Uterine activity via external Toco -
• -Maternal Pulse Rate
• Maternal Heart Rate via maternal ECG -
• -Noninvasive blood pressure (NBP)
• -Maternal temperature
• -Pulse oximetry (maternal SpO2)

The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:

• One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
• Uterine activity via intrauterine pressure (IUP) -
• -Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

This document describes the Philips Avalon Fetal/Maternal Monitors (FM20, FM30, FM40, and FM50) with software revision J.30.

The document does not explicitly list acceptance criteria in a table format with reported device performance alongside it. Instead, it states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" and that "The test results are passed and showed substantial equivalence."

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

Based on the provided text, a specific table of acceptance criteria and reported device performance is not explicitly given. The document generally states that the device "passed" tests based on the specifications of predicate devices.

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

The document mentions "Bench testing included the use of previously recorded patient raw signals and traces." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not provide information regarding the number of experts, their qualifications, or how they established ground truth for any test set.

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

The document does not describe any adjudication method used for a test set.

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

This document describes a medical device for monitoring physiological parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

The document describes performance verification and validation. While software testing was performed ("Software verification and validation testing were conducted"), it primarily focuses on the device's functionality and safety in relation to its predicate devices, rather than a standalone algorithm performance in a diagnostic context. The device is a "monitor" and its modifications are related to interfaces and measuring capabilities. There is no explicit mention of a standalone algorithm-only performance study.

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

The document mentions "previously recorded patient raw signals and traces" were used for bench testing. The quality and origin of these 'raw signals' as ground truth are not further specified beyond being "previously recorded."

8. The sample size for the training set:

The document does not mention a training set as this is not an AI/machine learning device in the typical sense that would require a distinct training set.

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

As no training set is discussed, information on how ground truth was established for it is not applicable and not provided.

Summary of Acceptance Criteria and Study:

The primary "acceptance criteria" appear to be meeting the specifications cleared for the predicate devices, and the "study" involved a series of non-clinical verification and validation activities.

Verification and Validation Activities Included:

• Biocompatibility testing (Cytotoxicity, Irritation, Delayed Type Hypersensitivity, Chemical characterization)
• Testing of new or impacted hazards from risk management analysis
• Software performance and regression verification and validation
• Performance and regression verification testing of wireless functionality
• Verification according to applicable EMC, safety, and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-37, ISO 80601-2-56, ISO 80601-2-61, IEC 62304, AAMI ANSI ISO 10993-1)
• Bench testing using previously recorded patient raw signals and traces.

The conclusion states that these non-clinical tests demonstrated that the modified devices are "as safe, as effective, and perform as well or better as the predicate devices" and "do not introduce new questions concerning the safety or effectiveness." No clinical studies were deemed necessary.

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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 Monitor family comprises the multi-parameter patient monitor models: MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MX600, MX700 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each monitor. The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive pressure, etc., generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network. The subject modification is enhancement of ProtocolWatch SCC Sepsis protocol by an introduction of configurable thresholds, modification of sepsis criteria and free text fields within the Sepsis Resuscitation Bundle and Sepsis Management Bundle phase of SSC Sepsis protocol. Additionally the software revision J.03 is made available for the entire IntelliVue Patient Monitors family.

The provided document is a 510(k) summary for the Philips IntelliVue patient monitors. It describes the modified devices, their intended use, and indicates that verification, validation, and testing activities were performed to establish performance, functionality, and reliability. However, it does not provide specific details on acceptance criteria or the study that proves the device meets those criteria with numerical performance metrics for any AI/ML component.

The primary context of this submission is an enhancement to the "ProtocolWatch SCC Sepsis protocol" by introducing configurable thresholds, modifying sepsis criteria, and adding free text fields. It also mentions a software revision J.03 for the entire IntelliVue Patient Monitor family. This suggests a software update to an existing device rather than a new AI/ML-driven diagnostic or prognostic tool.

Based on the provided text, I can extract the following:

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

The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate. Testing involved system level and as well as testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue patient monitors meet all reliability requirements and performance claims."

This is a general statement. Specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or other performance metrics) for the Sepsis Protocol enhancement or other features are not detailed in this 510(k) summary. Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported performance.

2. Sample size 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 510(k) summary. The document does not describe specific clinical studies or data sets used for testing the modified features.

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 510(k) summary. Given the nature of a patient monitor software update, it's unlikely that "experts" (in the typical sense of radiologists or clinicians reviewing cases for ground truth in an AI/ML context) were involved in a stated ground truth establishment process for this type of submission. The modifications relate to a "Sepsis protocol" which would likely be based on established clinical guidelines.

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

This information is not provided in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance is typical for AI-driven diagnostic tools. This submission describes a "Sepsis protocol" enhancement within a patient monitor, which is a clinical decision support tool rather than a standalone diagnostic AI. Therefore, an MRMC study is not applicable and was not mentioned. The document does not describe effects on human reader improvement.

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

The document mentions "Verification, validation, and testing activities" which "establish the performance, functionality, and reliability characteristics of the modified devices." This implies various forms of testing. However, it does not specifically refer to a "standalone" algorithm performance study in the context of AI/ML, nor does it provide metrics for such a study. The "Sepsis protocol" is described as a "clinical decision support tool," implying a human-in-the-loop context.

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

The document does not detail the specific ground truth used. For the "Sepsis Protocol," the ground truth would likely be based on established clinical guidelines and definitions for sepsis, rather than individual expert consensus on specific cases for an AI model.

8. The sample size for the training set

This information is not provided in the 510(k) summary. Given that the submission focuses on an "enhancement of ProtocolWatch SCC Sepsis protocol by an introduction of configurable thresholds, modification of sepsis criteria and free text fields," it's highly probable that this change involves logic and configuration updates based on medical knowledge, rather than a machine learning model that requires a dedicated "training set" in the conventional sense.

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

This information is not provided. As mentioned above, it's unlikely a "training set" in the AI/ML sense was used for this type of modification.

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Avalon Fetal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

Avalon Fetal Monitor FM40: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas,

Avalon Fetal Monitor FM50: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) with pulse rate, during antepartum testing and labor and delivery.

The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via ultrasound (US)
• Fetal Movement Profile
• Uterine activity via external Toco
• Maternal Pulse Rate
• Maternal Heart Rate (MHR) via maternal ECG
• Non-invasive blood pressure (NIBP)

The Avalon FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:

• Single Fetal Heart Rate via direct ECG (DECG)
• Twin Fetal Heart Rates via direct ECG (DECG) and/or ultrasound
• Uterine activity via intrauterine pressure (IUP)
• Maternal ECG (MECG)
• Pulse oximetry (maternal Sp02).
  *) Note: maximum three FHR's can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via ultrasound (US)
• Fetal Movement Profile
• Uterine activity via external Toco
• Maternal Pulse Rate
• Maternal Heart Rate (MHR) via maternal ECG
• Non-invasive blood pressure (NIBP).
• Pulse oximetry (maternal Sp02).

The Avalon FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:

• Single Fetal Heart Rate via direct ECG *) (DECG)
• Twin Fetal Heart Rates , via direct ECG (DECG) and/or ultrasound "
• Uterine activity via intrauterine pressure , (IUP)
• Maternal ECG (MECG) ,
  " Note: maximum three FHR's can be monitored.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K102958) does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a readily extractable table format.

Instead, it refers to the existing specifications cleared for the predicate devices as the basis for Pass/Fail criteria. The study concluded that the modified algorithm met these unstated criteria.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Some tests included the use of previously recorded patient traces," but doesn't quantify the number of traces or patients.
• Data Provenance: Not explicitly stated. The term "previously recorded patient traces" suggests retrospective data, but the country of origin is not mentioned.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned. It's unclear how ground truth was established from the "previously recorded patient traces" or if any adjudication was performed for the test set.

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

• Was an MRMC study done? No, there is no mention of a multi-reader, multi-case comparative effectiveness study involving human readers with and without AI assistance.
• Effect Size: Not applicable, as no MRMC study was reported.

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

• Was a standalone study done? Yes, the document describes "system level and regression tests" and testing of "the improved ultrasound performance algorithm." This implies a standalone evaluation of the algorithm's performance in addressing the identified issues of heart rate inaccuracies (halving, doubling, maternal heart rate mistaken for fetal). The focus of the 510(k) is on the algorithm modification itself.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. The document mentions using "previously recorded patient traces." For evaluating the accuracy of fetal heart rate detection and differentiation from maternal heart rate, an accurate reference (e.g., from a different, highly accurate monitoring method, or expert review of the original traces) would be required, but this is not detailed.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The document discusses an "improved ultrasound performance algorithm" which was a modification to existing devices. There is no mention of a "training set" in the context of machine learning or AI development in this summary. The algorithm improvement seems to be a programmatic enhancement rather than a machine learning model trained on data.

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

• How Ground Truth Was Established for Training Set: Not applicable, as no training set for an AI/ML model is indicated. The improvements described are algorithm modifications to address specific known problems with heart rate detection.

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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, recording and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment.

The modified device Philips M3001A Multi Measurement Server is substantially equivalent to the leqally marketed M3001A Multi Measurement Server (K030973, K033715). The modification consists of the integration of the Nellcor OxiMax SpO2 measurement module which is substantially equivalent to the legally marketed Nellcor OxiMax N-600x Pulse Oximeter (K060576). The modification adds to the M3001A Multi Measurement Server the Nellcor OxiMax SpO2 measurement module as an option in order to use the full Nellcor OxiMax technology. The modification is the integration of the Nellcor OxiMax SpO2 measurement module into the M3001A with minor hardware and software adaptations. The modification leads to a compact Multi measurement Server with integrated full Nelloor OxiMax technology.

The provided text describes the Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 measurement module. However, it does not contain a discrete "acceptance criteria" section with specified thresholds for performance metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to standards.

Here's an attempt to extract and infer information based on the provided text, structured as requested:

Acceptance Criteria and Study Details for Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 Measurement Module

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document explicitly states "Pass/Fail criteria were based on the specifications cleared for the predicate device." While specific numerical acceptance criteria other than the accuracy ranges for SpO2 and pulse rate are not provided, it's inferred that the acceptance criteria revolved around demonstrating performance equivalent to the legally marketed predicate devices and compliance with ISO 9919:2005.

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

• Sample Size for Test Set: The document mentions "controlled hypoxia studies with healthy non-smoking adult volunteers" for establishing calibration curves, but it does not specify the sample size for the test set used to validate the accuracy of the final device.
• Data Provenance: The SpO2 calibration curves are based on "controlled hypoxia studies with healthy non-smoking adult volunteers." The location or country of origin for these volunteers is not specified. The nature of the study for these calibration curves is prospective, as they involve controlled studies. The verification, validation, and testing activities mentioned for the full device are likely internal tests, but no further details on their provenance are provided.

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

The document does not mention the use of experts to establish ground truth for a test set in the context of the device's performance validation. The SpO2 values are derived from a physiological principle (absorption of light and ratio of oxygenated hemoglobin) and calibrated against in vivo hypoxia studies, not expert interpretation.

4. Adjudication Method for the Test Set

Since there is no mention of experts establishing ground truth or subjective assessments, there is no adjudication method described.

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

No MRMC comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the standalone performance of the device's physiological measurements.

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

Yes, the information provided describes a standalone performance evaluation of the device. The accuracy of SpO2 and pulse rate, and the overall functionality, were tested without explicit human-in-the-loop interaction for interpretation or decision-making related to the device's core measurements. The SpO2 measurement is "based on the absorption of light" and calculated through "Out of calibration curves."

7. Type of Ground Truth Used

The ground truth for the SpO2 measurement accuracy relies on:

• Physiological principle: The definition of SpO2 as the percentage ratio of oxygenated hemoglobin to total hemoglobin.
• Controlled hypoxia studies: Data obtained from "controlled hypoxia studies with healthy non-smoking adult volunteers" was used to establish calibration curves, which then serve as the reference for determining SpO2 values from the light absorption ratio. This implicitly means that the actual blood oxygen levels during these controlled studies served as the ground truth for calibration curve development.

For the general functional and reliability testing, the ground truth was "specifications cleared for the predicate device" and compliance with ISO 9919:2005.

8. Sample Size for the Training Set

The document does not explicitly use the term "training set." However, the "calibration curves" for SpO2 are based on "controlled hypoxia studies with healthy non-smoking adult volunteers." The sample size for these studies (which serve as the basis for the device's internal calibration/training equivalent) is not specified.

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

The "calibration curves" (analogous to a training set for the SpO2 algorithm) were established using data from "controlled hypoxia studies with healthy non-smoking adult volunteers." In these studies, subjects are typically desaturated under controlled conditions, and their arterial blood oxygen saturation is measured directly using a co-oximeter (considered the gold standard for oxygen saturation in blood), which would serve as the ground truth. The ratio of red and infrared light absorption from the oximeter is then correlated with these direct blood oxygen measurements to create the calibration curves.

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Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.

The modified device Philips IntelliVue MP5 Patient Monitor with Microstream Side Stream CO2 Measurement Module. The modification consists of the integration of the Microstream CO2 Measurement Module, which is substantial equivalent to the legally marketed Philips M3015A Measurement Server Extension (K993383) and to the Oridion Capnostream2o with A2 Adaptive Averaging Software and Extended CO2 Measurement Range (K072295).

The provided text describes the Philips IntelliVue MP5 Patient Monitor with an integrated Microstream Side Stream CO2 Measurement Module. The document focuses on showing substantial equivalence to predicate devices rather than providing a detailed acceptance criteria table with specific performance metrics and their verification.

Here's a breakdown of the information that can be extracted, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria (e.g., minimum accuracy rates, sensitivity, specificity) for specific physiological parameters. Instead, it states that the device was validated according to ISO 21647 for accuracy and that "Pass/Fail criteria were based on the specifications cleared for the predicate device." It also claims that "test results showed substantial equivalence" and that the device "meets all reliability requirements and performance claims."

Therefore, based on the provided text, a detailed table cannot be constructed. The implicit acceptance criteria are that the device performs equivalently to the predicate devices and meets relevant ISO standards.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It generically mentions "system level tests, performance tests, and safety testing from hazard analysis."

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

This information is not provided in the document.

4. Adjudication Method

This information is not provided in the document.

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

No MRMC study is mentioned in the document. The study described is not focused on human reader performance with or without AI assistance, but rather on the technical performance and equivalence of the device itself.

6. Standalone Performance

The description of "system level tests, performance tests, and safety testing" implies that standalone (algorithm only without human-in-the-loop) performance testing was conducted to demonstrate the device's functional integrity and equivalence to predicate devices. However, specific metrics of this standalone performance are not provided beyond the general statement of meeting "all reliability requirements and performance claims."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. Given the context of monitoring physiological parameters (like CO2 measurement accuracy), the ground truth would likely be established through highly accurate reference measurement devices or laboratory-grade instruments. The validation against ISO 21647 suggests adherence to established standards for verifying accuracy against a known truth.

8. Sample Size for the Training Set

No information about a "training set" or its sample size is provided. This is expected as the device in question is a patient monitor with an integrated CO2 module, not typically an AI/machine learning algorithm requiring a distinct training set in the modern sense. The "training" for such devices involves calibration and validation against known standards.

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

Since no training set is mentioned, this information is not available.

Summary of Study Information:

• Study Type: Verification, validation, and testing activities focused on demonstrating substantial equivalence to predicate devices.
• Key Validation Standard: Accuracy was validated according to ISO 21647.
• Comparison: The modified device (Philips IntelliVue MP5 Patient Monitor with Microstream CO2) was compared to its legally marketed predicate device (IntelliVue MP5 Patient Monitor (K063725, K081793)) and the Microstream CO2 module was compared to the Philips M3015A Measurement Server Extension (K993383) and the Oridion Capnostream2o (K072295).
• Conclusion: "Test results showed substantial equivalence" and "The results demonstrate that the Philips IntelliVue MP5 Patient Monitor meets all reliability requirements and performance claims."

In conclusion, while the document confirms that a study was conducted to demonstrate the device's performance and substantial equivalence according to ISO 21647 and predicate device specifications, it lacks the detailed quantitative acceptance criteria and specific study metrics (like sample sizes, expert details, or ground truth establishment methods) that would typically be associated with modern AI/ML device studies.

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