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The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.

The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.

The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.

Sentec's Digital Monitoring System is intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR) in adult and pediatric patients as well as for PCO2 and PO2 monitoring in neonatal patients.

The tCOM+ (REF 103164) is a portable, lightweight, stand-alone monitor with a convenient carrying handle and with an integrated calibration and storage facility for the V-Sign™ Sensor 2 or OxiVenT™ Sensor, respectively. It provides continuous and noninvasive PCO2, SpO2 and PR monitoring if used with a V-Sign™ Sensor 2 or PCO2, PO2, SpO2 and PR monitoring if used with a OxiVenT™ Sensor.

Acceptance Criteria and Study for Sentec Digital Monitoring System (SDMS) tCOM+

The Sentec Digital Monitoring System (SDMS) tCOM+ is a transcutaneous blood gas monitoring system intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PO2), oxygen saturation (SpO2), and pulse rate (PR). The tCOM+ is an updated version of the previously cleared Sentec Digital Monitor (SDM), with technological upgrades such as a touchscreen user interface and wireless communication capabilities.

The submission focuses on demonstrating substantial equivalence to its predicate device, the SDM, and updated disposables. The core performance of the device, particularly its measurement modalities, is considered unchanged from the predicate. Therefore, the acceptance criteria and supporting studies primarily revolve around verifying the safety and effectiveness of the new monitor features and updated accessories, and demonstrating that the clinical performance remains consistent with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not specify sample sizes for test sets in the context of clinical performance data. The submission explicitly states:

• "No clinical performance data were generated on the tCOM+, because compared to its predicate device, the Sentec Digital Monitor (SDM), it uses the same sensors without software changes impacting algorithm or clinical performance."
• "The introduction of the updated disposables...do not affect the clinical functionality or performance of Sentec's Digital Monitoring System. No further clinical data was required to support safety and performance."

Therefore, there isn't a "test set" of patient data for clinical performance in the context of the tCOM+ submission. The testing done involved non-clinical performance (bench testing, biocompatibility, risk management, software validation, human factors) and compliance with various recognized standards.

For the Human Factors Evaluation testing, while a sample size for participants is typically part of such studies, the document does not disclose this information or the data provenance.

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

Given that "no clinical performance data were generated" for the tCOM+ as the clinical functionality and performance are considered unchanged from the predicate, no experts were used to establish ground truth for a new clinical test set for this submission. The ground truth for the predicate device's performance would have been established during its initial clearance, but that information is not part of this 510(k) summary.

4. Adjudication Method for the Test Set

Since no new clinical test set was generated for the tCOM+, there was no adjudication method employed for clinical data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that no clinical performance data were generated for the tCOM+, as the device's core measurement technology and algorithms are identical to its predicate. Therefore, there is no effect size reported for human readers with or without AI assistance, as AI assistance is not described as a new feature requiring such a study.

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

The submission does not specifically describe a standalone (algorithm only) performance study in the context of new clinical data. The device is a monitoring system that interacts with a human user (professional medical personnel or trained lay operators). The core measurement algorithms for PCO2, PO2, SpO2, and PR are stated to be "unchanged" and "identical" to the predicate. The software development and testing focused on verification to requirements and validation to meet specified intended uses, implying the algorithm's performance inherited from the predicate was considered sufficient.

7. The Type of Ground Truth Used

For the non-clinical aspects:

• Mechanical, Electrical, EMC, Safety Standards: Compliance with industry-recognized standards (e.g., IEC 60601 series, ISO 80601-2-61). The "ground truth" here is adherence to the technical specifications and test methodologies defined by these standards.
• Biocompatibility: Compliance with ISO 10993-1:2018. The "ground truth" is established by laboratory testing results against the criteria within this standard.
• Risk Management: Identification and mitigation of hazards, with acceptable residual risks. The "ground truth" is the thoroughness of the risk analysis and the documented resolution of identified risks.
• Software Development: Verification to requirements and validation to intended use. The "ground truth" is the functional correctness and reliability of the software against its specifications.
• Human Factors: Conformance to usability engineering principles as per FDA guidance. The "ground truth" is successful completion of human factors testing.

For clinical performance, the ground truth is assumed to be equivalent to the predicate device's established clinical ground truth, as the core measurement technology, sensors, and algorithms remain unchanged. The original predicate device's clearance would have relied on appropriate clinical data (e.g., comparison to arterial blood gas measurements for PCO2/PO2, or co-oximetry for SpO2), but this is not detailed in the current submission.

8. The Sample Size for the Training Set

The submission does not mention a training set in the context of new algorithm development or machine learning. Since the software changes primarily relate to the user interface and connectivity, and the measurement algorithms are "identical to the configuration listed under K151329" (the predicate), there was no new training required for clinical algorithms.

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

As no new training set for algorithms was used in this submission, this question is not applicable.

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

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

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

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and 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 4-Slot Module rack FMX-4 is intended to connect up to four particular plug-in physiological measurement modules to the dedicated host patient monitors.

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

The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, ScvO2, EEG, BIS, NMT, and gas analysis.

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

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

The hardware of the new 4-Slot Module Rack FMX-4 is very similar to that of its 8 years old predicate 4-Slot Module Rack FMS-4. The new FMX-4 has the same housing, which is made of the same material as FMS-4 but has a slightly different shade of color (same shade of color as the new MX750 and MX850 monitors). The FMX-4 has a new Printed Circuit Assembly with standard hardware components like CPU and memory being replaced by state of the art electronic components.

The software modifications comprise the following changes:

• Support of the new state-of-the-art electronic components.
• Modified elements of the Graphical User Interface.
• Implementation of a feature called Electronic Strip Recording. This feature allows electronic strips that can be reviewed on the monitor and printed out as a report on the printer.
• Modification of the existing feature Remote Applications to support HTML5 and PDF format.

This document is a 510(k) summary for the Philips IntelliVue Patient Monitors MX750 and MX850 and the IntelliVue 4-Slot Module Rack FMX-4. It states that these devices are substantially equivalent to previously cleared predicate devices (Philips IntelliVue Patient Monitor MX800 and Philips IntelliVue 4-Slot Module Rack FMS-4). The submission primarily focuses on hardware and software modifications to existing devices.

The information provided does not detail specific acceptance criteria and device performance in the format of a table with numerical values for metrics like sensitivity, specificity, or accuracy, as would be common for an AI/ML device study. Instead, it describes compliance with recognized consensus standards and general V&V activities. This is likely because the device is a patient monitor, and the modifications are primarily hardware updates and minor software changes to support the new hardware and improve existing functionalities, not a new AI/ML algorithm requiring extensive clinical performance validation against a pre-defined ground truth for diagnostic accuracy.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance) are not explicitly addressed in the provided text as they pertain more to novel diagnostic or AI algorithms rather than general patient monitoring device updates.

I can, however, extract information about the types of tests conducted and general statements about meeting requirements.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific numerical acceptance criteria and corresponding device performance metrics (e.g., sensitivity, specificity, AUC) for the various physiological parameters monitored by the device. Instead, it states that "Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence with respect to safety and effectiveness."

The V&V activities focused on compliance with various international standards:

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

The document does not specify a "test set" in terms of subject count or data record count for performance evaluation in the context of, for example, diagnostic algorithm accuracy. The studies described are primarily engineering validation and verification tests against established standards. Therefore, information regarding data provenance (e.g., country of origin, retrospective/prospective) is not provided.

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

As there is no "test set" described for a diagnostic algorithm, this information is not applicable and not provided in the document. The human factors engineering testing involved "focus groups" and "expert reviews," but the number and qualifications of these experts are not specified, nor were they establishing ground truth for a diagnostic outcome.

4. Adjudication method for the test set

Not applicable, as no dedicated "test set" requiring adjudication for ground truth of a diagnostic outcome is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No MRMC comparative effectiveness study is mentioned. The device is a patient monitor, and the submission concerns updates to an existing monitoring platform, not a new AI diagnostic aid that would typically warrant such a study.

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

This concept is less applicable to a patient monitoring device update. The performance evaluation focuses on the device's ability to accurately measure and display physiological parameters and generate alarms in compliance with safety and performance standards, rather than an autonomous diagnostic algorithm. The document states the monitors are "for use by trained healthcare professionals."

7. The type of ground truth used

For the various measurement parameters (ECG, SpO2, etc.), the "ground truth" implicitly aligns with the accuracy and performance specifications outlined in the referenced standards (e.g., AAMI EC11 for ECG, ISO 80601-2-61 for pulse oximetry). These standards define acceptable deviations from known physical or simulated physiological signals. The document does not describe the establishment of ground truth in the context of expert consensus, pathology, or outcomes data, as would be relevant for a diagnostic AI algorithm.

8. The sample size for the training set

This information is not provided. The document primarily describes hardware and software updates to an existing system, rather than the development and training of a new AI/ML algorithm.

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

Not applicable, as the document does not describe the development or training of a new AI/ML algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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 SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories - is indicated for continuous, noninvasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in clinical and non-clinical settings such as hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and - if under clinical supervision-home environments. The SenTec Digital Monitoring System is for prescription use only.

The V-Sign Sensor 2, model VS-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of V-Sign Sensor 2 is indicated for carbon dioxide tension monitoring only.

The OxiVenT Sensor, model OV-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension as well as oxygen saturation and pulse rate are required for adult and pediatric patients. In neonatal patients the use of OxiVenT Sensor is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

SenTec's Ear Clip, model EC-MI, is intended for use with the V-Sign Sensor 2 when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring and with the OxiVenT Sensor when continuous, noninvasive carbon dioxide and oxygen tension monitoring as well as oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach the V-Sign Sensor 2 or OxiVenT Sensor to the earlobe of the patient. The use of the Ear Clip is contraindicated for patients whose earlobes are too small to ensure adequate sensor application.

SenTec's Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach V-Sign Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, noninvasive carbon dioxide tension monitoring is required for adult, pediatic, and neonatal patients. The Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the OxiVenT Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninyasive carbon doxide and/or oxygen tension monitoring is required for adult, pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-MI, are intended to attach the V-Sign Sensor 2 or the OxiVenT Sensor to the forehead, cheek, upper arm as well as on the back above the shoulder blade. The Multi-Site Attachment Rings, model MAR-MI, are for single use.

SenTec's Staysite Adhesive pad for MAR, model SA-MAR, is an optional, single-use adhesive pad which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF, if more secure attachment is required. The Staysite Adhesive pad for MAR, model SA-MAR, is for single use.

V-STATS is an optional PC-based software which is indicated for use with the SenTec Digital Monitor (SDM) when remote monitoring and/ or trend reporting and statistical analysis of data measured by the SDM is required. V-STATS is not intended to provide diagnosis; it is intended to supplement and not to replace any part of the SDM monitoring procedures.

The SenTec Digital Monitoring System (SDMS) as listed under K101690 is a device consisting of a standalone monitor [SenTec Digital Monitor (SDM)], the digital sensors V-Sign™ Sensor (model VS-A/P) and its successor V-Sign™ Sensor 2 (model VS-A/P/N), connecting cables, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR) using the ear lobe, forehead or cheek as monitoring site in adult and pediatric patients. It is furthermore designed for PCO2-only monitoring in adult, pediatric and neonatal patients using conventional PCO2 measurement sites. V-STATS™ is an optional PC software application for remote monitoring and/or trend reporting and statistical analysis of the data measured with the SDMS.

The additions and expanded indications of the SenTec Digital Monitoring System (SDMS) introduced by this new 510(k) submission are summarized below:

• This new 510(k) submission expands the intended use of the SDMS by introducing non- invasive, transcutaneous oxygen (tcPO2) by measuring the oxygen partial pressure (PO2) as new monitoring parameter to the SDMS. Introducing the tcPO2 parameter includes updated firmware versions of the existing SenTec Digital Monitor (SDM) and the introduction of a new digital sensor (OxiVenT™ Sensor, see below).
• This new 510(k) submission introduces SenTec's OxiVenT™ Sensor, model OV-A/P/N. The - OxiVenT™ Sensor is a combined sensor for the continuous measurement of transcutaneous oxygen (tcPO2), as well as the previously cleared measurement of transcutaneous carbon dioxide (tcPCO2), oxygen saturation (SpO2) and pulse rate (PR).
• V-Sign™ Sensor 2 (model VS-A/P/N) has been cleared under K101690. This new 510(k) submission expands the intended use by introducing new SpO2/PR measurement sites in adult and pediatric patients: Next to the already existing measurement sites on the forehead and cheek, new the upper arm and area on the back above the shoulder blade are added.
• This new 510(k) submission expands the intended use of the Multi-Site Attachment Rings, models MAR-MI and MAR-SF, approved under K101690 and K071672. to attach the new OxiVenT™ Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninyasive carbon dioxide and/or oxygen tension monitoring is required for adult. pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the V-Sign™ Sensor 2 or the new OxiVenT™ Sensor to the forehead, cheek, as well as the new pulse oximetry (SpO2/PR) measurement sites upper arm as well as on the shoulder blade.
• This new 510(k) submission introduces the Staysite™ Adhesive pad (REF SA-MAR), an additional adhesive pad that can be used optionally if more secure attachment is required – the pad is attached on top off the Multi-Site Attachment Rings (MAR-SF/MI).
• The V-STATS™ PC software for trend data reporting and remote monitoring (cleared in K101690) has been updated to version 4.00 in order to incorporate download and display of the new PO2 parameter.

In total, the modifications, additions, and enhancements described above represent the step-wise evolution of the SenTec Digital Monitoring System (SDMS) to provide improved monitoring as well as expanded measurement and reporting capabilities. A traditional 510(k) has been selected instead of a special 510(k) because some of the changes affect the indications for use.

The provided text describes the SenTec Digital Monitoring System (SDMS) and its modifications/expansions, focusing on proving its substantial equivalence to predicate devices. However, it does not explicitly
detail a randomized controlled trial (RCT) or a specific study that includes all the requested elements for acceptance criteria and device performance in a summary table format. Instead, it references various tests and studies conducted to ensure compliance with standards and demonstrates performance.

Here's an attempt to extract and synthesize the information based on your request, as much as possible from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of what you'd typically expect for a clinical study with primary and secondary endpoints. Instead, it lists technical specifications and accuracy claims, often comparing them to predicate devices. The "reported device performance" is given as meeting these specified accuracy requirements or being equivalent to predicate devices.

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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 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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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 SpO2 and pulse rate wirelessly.
The intended use of the IntelliVue CL SpO3 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, and recording of, and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients.
The IntelliVue CL SpO2 Pod is also intended for local attended monitoring of, and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients.
The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxygen saturation and pulse rate data of adult and pediatric patients for a clinical information management system.
The Intelli Vue 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.
Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the Intelli Vue CL SpO2 Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room.

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 and recording of, and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients.
The IntelliVue CL NBP Pod is also intended for local attended monitoring of, and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients.
The IntelliVue CL NBP Pod is also intended for acquisition of svstolic, 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.
Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the Intelli Vue CL NBP Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room.

IntelliVue Patient Monitors MP5. MP5T, and MP5SC:
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, MP5SC and MP5T monitors are also intended for use during patient transport inside the hospital environment; only the MPS monitor is for use during patient transport outside of the hospital environment. The MP5, MP5SC and MP5T when used with the TRx4841 A/TRx4851 A IntelliVue Telemetry System Transceiver or with the Intelli Vue 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 rhvthm and detailed morphology of complex cardiac complexes (according to AAMIEC II).
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 Integrated Pulmonary index (IPI) is intended for use with adult and pediatric (I 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 CL SpO2 Pod is a small, battery powered, wrist worn pulse oximeter device for cableless monitoring of patients. It contains Philips FAST-SpO2 (Fourier Artifact Suppression Technology) to provide reliable saturation values under various artifact conditions including motion and low perfusion. It uses a measurement principle that is based on the specific absorption characteristics of oxyhemoglobin and deoxyhemoglobin and the pulsating arteriolar vascular bed at the measurement site. It provides continuous operating mode and intermittent operating mode with configurable measurement intervals. The integrated monochrome LCD display shows measured values, measurement signal quality, battery state, and RF signal strength. It communicates measurement values and other information to an IntelliVue Patient Monitor or an IntelliVue Information Center via a telemetry device. It also acquires SpO2 and pulse rate data for a clinical information management system. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable SpO2 sensors.
The IntelliVue CL NBP Pod is a small. battery powered, non-invasive blood pressure and pulse rate measurement device for cableless monitoring of patients. It uses oscillometric method for measuring NBP. It produces numerics for systolic. diastolic and mean blood pressure values and pulse rate. The integrated monochrome LCD Display shows measured values, battery state, and RF signal strength. It communicates measurement values and other information to an IntelliVue Patient Monitor or an IntelliVue Information Center via a telemetry device. It also acquires systolic, diastolic, and mean pressure and pulse rate data for a clinical information management system. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable NBP cuffs and air hoses. Both measuring devices the CL SpO2 Pod and the CL NBP Pod can also be controlled from an assigned IntelliVue Patient Monitor, an IntelliVue Information Center via a telementy device, or from the IntelliVue GuardianSoftware via the hospital IT infrastructure. They communicate with the compatible devices using a wireless Short Range Radio (SRR) interface in the 2.4 GHz ISM frequency band.
The modification to the IntelliVue CL SpO2 Pod and CL NBP Pod enables local physiological alarm indication on these devices for local attended monitoring without a host patient monitor, e.g. during in-hospital transport attended by a care giver. This notifies clinical personnel about possibly threatening situations for a patient.
The modification to the IntelliVue CL SpO2 Pod introduces pulse tone and pulse tone modulation locally at the IntelliVue CL SpO2 Pod to allow clinical personnel to hear deviations of the patients pulse frequency and saturation levels also during local attended monitoring (without a patient monitor).
The IntelliVue CL NBP Pod has additionally been modified in order to enhance accuracy of diastole and Mean Arterial Pressure (MAP) measurements in order to enhance the margin to the limits specified in the recognized consensus standards ANSI/AAMI SP10 and ISO 81060-2.
To supplement the range of measurement accessories, the CL NBP Pod has also been validated for use with a series of additional, legally marketed Philips cuffs. To connect the additional Philips cuffs a new adapter hose, the Mobile CL Air Hose-Bayonet Connector (model No .: 989803187431), has been setup and added to the list of accessories. As the legally marketed Philips Mobile CL Extension Air Hose, the new hose is explicitly intended for use with the IntelliVue CL NBP Pod.
The IntelliVue Patient Monitors MP5, MP5T, and MP5SC consist of 8.4" TFT LCD display unit including built-in central processing unit (CPU) and multiple physiological measurements. All monitor models share the same architecture of CPU units and the same software is executed on each monitor. They are robust, portable, lightweight, compact in size and modular in design, with interfaces to dedicated external measurement devices. The MPS. MP5T and MP5SC monitors have varying measurement sets and network capabilities. All models can be used with adult, pediatric and neonatal patients in a hospital and transport environment. They store data in trend, event, and calculation databases. Tabular trends (vital signs) can be watched on display and documented on a printer.
The MP5 monitor provides a comprehensive set of basic physiological measurements: NBP, SpO2, and optionally ECG, invasive blood pressure, predictive temperature, standard temperature and CO2. Through networking it provides information integration, documentation and information access.
The MP5T monitor is intended for use together with a telemetry device. It has no ECG measurement of its own but does have NBP and optionally SpO2 and predictive temperature. When the telemetry device is directly connected to the MP5T. the measurements from the MPST are transmitted with those from the telemetry device (ECG and optionally SpO2) to the Information Center.
The MP5SC monitor is customized for use as a multi-patient spot check monitor. It has SpO2 and NBP and optionally predictive temperature or Microstream CO2. A telemetry device can be connected via short range radio (SRR) to the MP5SC to provide an ECG measurement.
When used together with the IntelliVue CL SpO2 Pod and CL NBP Pod. the MP5. MPST, and MPSSC monitors receive via Short Range Radio (SRR) interface measurement values. The measurement data is displayed and recorded on the patient monitors. The patient monitors also receive technical and physiological alarms generated in the CL SpO2 and NBP Pods for their audible and visual indication on the monitors. In addition, the patient monitors can control some functions of the CL SpO2 and NBP Pods via SRR link.
The common software of the IntelliVue Patient Monitors MP5. MP5T. and MP5SC has slightly been modified to allow the operator to start and to end local attended monitoring of the IntelliVue CL SpO2 Pod and CL NBP Pod.

The provided text is a 510(k) summary for the Philips IntelliVue CL SpO2 Pod, CL NBP Pod, and IntelliVue Patient Monitors MP5, MP5T, MP5SC. This document describes regulatory information, device descriptions, and summaries of verification and validation activities.

However, the document does not describe an AI/ML-based device. It pertains to physiological monitoring devices (pulse oximeters, non-invasive blood pressure monitors, and patient monitors). The performance validation activities described are for these traditional medical devices, focusing on accuracy against standards, durability, and usability, rather than AI model performance metrics like sensitivity, specificity, or AUC based on ground truth established by expert consensus or pathology.

Therefore, I cannot extract the information required by your questions, such as:

1. A table of acceptance criteria and reported device performance (in the context of AI metrics).
2. Sample size used for the test set and data provenance (for AI model testing).
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size for human readers with/without AI assistance.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI models.
8. Sample size for the training set (for AI models).
9. How the ground truth for the training set was established (for AI models).

The document states: "The IntelliVue CL NBP Pod has additionally been modified in order to enhance accuracy of diastole and Mean Arterial Pressure (MAP) measurements in order to enhance the margin to the limits specified in the recognized consensus standards ANSI/AAMI SP10 and ISO 81060-2." and "The modified IntelliVue CL NBP Pod met all safety and efficiency requirements and demonstrated that the accuracy requirements (measured by means of mean error and standard deviations, using the same Arm Sequential Method - Dual Observer - in Comparison to a Mercury Reference Sphygmomanometer) for the number of subjects..." This indicates traditional medical device accuracy validation, not AI model performance.

In summary, the provided document does not contain information about an AI/ML-based device and its associated acceptance criteria and study proving it meets those criteria in the context of AI/ML performance.

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