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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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Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals.

X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.

The SpO2 measurement is based on the absorption of light, which is emitted through human tissue (i.e. index finger). Two light sources transmit red and infrared light through the human tissue. The ratio of the different absorption of the red and infrared light is calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO₂] to the total amount of hemoglobin [Hb] (SpO2 = [HbOz]/({Hb]+[HbO2]). Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value. The measurement accuracy of SpO2 in the range of 70% to 100% is between 2% and 4% RMS dependent on the Philips sensor type. The measurement accuracy of pulse rate in the range of 30 bpm to 300 bpm is 2% or 1 bpm (whichever is greater).

The modification is a hardware and firmware improvement and reduces the manufacturing costs.

Here's an analysis of the acceptance criteria and study details for the picoSAT IIP408 SpO2 pulse oximetry module, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 10 volunteers
• Data Provenance: Controlled hypoxia studies with healthy non-smoking adult volunteers. Since the submitter is Philips Medizin Systeme Böblingen GmbH (Germany), it's highly likely the study was conducted in Germany or a similar Western country, but the specific country of origin is not explicitly stated. The study was prospective in nature due to it being a "controlled desaturation study."

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

• Number of Experts: Not applicable in this context.
• Qualifications of Experts: The ground truth was established by a CO-Oximeter as a reference, not human experts. CO-Oximeters are laboratory-grade instruments used for highly accurate blood gas analysis, including oxygen saturation.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by instrumental reference (CO-Oximeter) rather than human expert interpretation requiring 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

• MRMC Study Done: No. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

• Standalone Study Done: Yes, essentially. The accuracy of the SpO2 measurement is a direct output of the device's hardware and firmware, compared against a reference standard. There is no human "in-the-loop" for the direct SpO2 measurement process itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Instrumental reference – a CO-Oximeter was used to provide SaO2 (arterial oxygen saturation) reference values.

8. The Sample Size for the Training Set

• Sample Size: Not explicitly stated as a distinct "training set" in the context of machine learning model development. For traditional medical device calibration (as described here), "calibration curves" are developed. While the text mentions "Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value," it does not specify a separate sample size for developing these curves, implying some overlap or that the 10 volunteers may have contributed to this process. It explicitly states "at least 20 data samples per volunteer" for the validation study.

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

• Ground Truth Establishment: The "calibration curves" (analogous to a training process for establishing the device's core functionality) were "based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%)." This implies that during these hypoxia studies, a reference method (likely a CO-Oximeter, similar to the validation) was used to establish the true SaO2 values against which the device's internal light absorption ratios were mapped to create the SpO2 output.

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