Search Results

Ask a specific question about this device

The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), and cardiac output (C.O.).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The NIBP monitoring supports iCUFS algorithm and iFAST algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatric patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

The CX&UX series Patient Monitor including CX10/CX12/CX15/UX10/UX12/UX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.

Minor differences from the predicate device are limited to some modifications of monitoring parameter specifications. These updates do not change the fundamental scientific technology of the cleared predicate device and thus do not raise any questions about the safety and effectiveness of the subject device.

The provided FDA 510(k) clearance letter details the device's technical specifications and comparisons to predicate devices, along with the non-clinical performance data and adherence to various IEC and ISO standards. However, it explicitly states: "Clinical data: The subject device did not require new clinical studies to support substantial equivalence."

This means that the submission for this Patient Monitor device (CX10, CX12, CX15, UX10, UX12, UX15) relies on demonstrating substantial equivalence to a legally marketed predicate device (Edan Instruments, Inc., Patient Monitor Model iX10, iX12, iX15, K232962) through non-clinical performance testing and software verification/validation, rather than new clinical trials or studies involving human patients.

Therefore, the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria through clinical performance (e.g., sample size for test set, expert involvement, MRMC studies, ground truth establishment for test/training sets, effect size of human reader improvement with AI) cannot be extracted from this document, as such clinical studies were explicitly not required for this 510(k) submission.

The document focuses on demonstrating that the new device's technical specifications and performance are similar to the predicate device, and that it complies with relevant safety and performance standards through bench testing.

Here's what can be extracted from the provided text regarding acceptance criteria and the type of study performed, specifically focusing on the non-clinical aspects:

Device: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

The acceptance criteria for this device are implicitly tied to its performance meeting the standards and accuracy specifications of the predicate device and relevant international standards. Since no new clinical studies were conducted, the "proof" comes from non-clinical bench testing and software validation.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

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

• Sample Size: Not applicable in terms of human subjects or patient data test sets, as "new clinical studies" were not required. The "test set" refers to bench testing and functional system-level validation. The specific number of test cycles or a detailed breakdown of test cases for bench testing is not provided in this summary.
• Data Provenance: The data primarily originates from Edan Instruments Inc. (Shenzhen, Guangdong, China) through internal engineering and quality assurance processes for non-clinical bench testing and software validation. It is not patient data, so concepts like "retrospective or prospective" do not apply.

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

• Not applicable for clinical ground truth: Since no clinical studies were performed requiring human interpretation or diagnosis for a test set, no medical experts (e.g., radiologists) were used to establish ground truth in this context.
• Internal experts: Bench testing and software validation would have involved engineers and quality assurance professionals, whose qualifications are implicit in the quality system (21 CFR Part 820) but not specified in detail here.

4. Adjudication Method for the Test Set:

• Not applicable: Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving multiple readers. This was not a clinical study. Bench testing relies on established technical specifications and standard compliance.

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

• No: No MRMC study was performed as no new clinical studies were required or conducted. Therefore, there's no effect size of human readers improving with AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

• Yes (for the technical components): The "performance testing-Bench" effectively represents a standalone evaluation of the device's functional components (ECG, NIBP, SpO2, etc.) and software against defined technical specifications and standards. The "software verification and validation testing" also represents a standalone evaluation of the algorithm and software functions. The specific algorithms (e.g., iCUFS, iFAST for NIBP, arrhythmia analysis logic) are tested independently for their accuracy against known inputs or reference standards as part of bench testing.

7. The Type of Ground Truth Used:

• Technical/Reference Standards: For the bench testing, the "ground truth" would be derived from:
  • Reference standards/simulators: Calibrated medical equipment, physiological simulators, and test signals (e.g., known ECG waveforms, simulated blood pressure readings, temperature standards) are used to provide the "true" values against which the device's measurements are compared.
  • Defined specifications: The device's internal design specifications and the requirements of the referenced IEC/ISO standards serve as the "ground truth" for compliance testing.
• Not clinical ground truth: No expert consensus, pathology, or outcomes data from real patients were used for establishing ground truth for this submission.

8. The Sample Size for the Training Set:

• Not applicable: The device is a patient monitor, not a machine learning/AI algorithm that typically undergoes a distinct "training" phase with a large dataset. Its functionality is based on established physiological measurement principles and programmed algorithms. Any internal calibration or algorithm refinement would be part of the product development process, not a dedicated "training set" in the AI/ML sense.

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

• Not applicable: As there was no "training set" in the context of an AI/ML model, the concept of establishing ground truth for it does not apply to this 510(k) submission.

In summary, this 510(k) clearance relies on demonstrating that the new Patient Monitor is substantially equivalent to a previously cleared predicate device, primarily through robust non-clinical bench testing and software validation, proving compliance with established medical device standards and functional specifications. No new clinical studies with patient data were required or conducted for this specific submission.

Ask a specific question about this device

The RespArray™ patient monitor is intended to be used for monitoring, storing, reviewing 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 hospital environments. The monitor is for prescription use only.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and carbon dioxide (CO2).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The SpO2 (Nellcor™) module is intended to be used for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), in motion and no motion conditions, and in patients who are well or poorly perfused.

The Microstream™ capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (etCO2) and respiration rate (RR). The monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is not intended for patients up to the age of one year. A/hr and ODI are intended for ages 22 and up.

The monitors are not intended for MRI environments.

The RespArray patient monitor (hereinafter called RespArray) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

The provided text is a 510(k) summary for the Edan Instruments Patient Monitor (RespArray). It focuses on establishing substantial equivalence to a predicate device, primarily through non-clinical performance and software verification/validation.

Crucially, the document explicitly states: "Clinical data: Not applicable." This means there was no clinical study conducted to prove the device meets specific acceptance criteria in a human-use setting, particularly relating to diagnostic accuracy where AI assistance or expert consensus would be relevant.

Therefore, many of the requested items, such as multi-reader multi-case studies, ground truth establishment for a test set, and sample sizes for clinical test sets, are not applicable to this submission as per the document's contents.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria discussed are primarily related to electrical safety, electromagnetic compatibility (EMC), and general performance of the physiological parameter measurements (ECG, RESP, NIBP, TEMP, SpO2, CO2). The document states that the device was found to comply with relevant standards and that bench testing shows it meets its accuracy specification and relevant consensus standards.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-clinical data" including:

• Electrical safety and electromagnetic compatibility (EMC) assessments.
• Performance testing-Bench
• Software Verification and Validation Testing.

Detailed Information on the Study:

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

   • Sample Size: Not explicitly quantified in terms of number of patients or physiological measurements. The testing was "bench" testing, meaning laboratory-based tests on the device's functionality and accuracy against reference standards, rather than patient-derived data.
   • Data Provenance: Not applicable in the context of clinical data. For testing against standards, it implies standardized test setups and simulated physiological signals/conditions.

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

   • Not applicable. No experts were used for ground truth establishment as it was non-clinical bench testing against established engineering and medical device performance standards. There's no "ground truth" of a diagnostic nature being established by human experts in this context.

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

   • Not applicable. Adjudication is relevant for human-interpreted diagnostic data. This study relies on objective measurements against engineering specifications and international standards.

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

   • No, not applicable. The device is a patient monitor, not an AI-assisted diagnostic tool that interprets medical images/signals for improved human reader performance. The submission explicitly states "Clinical data: Not applicable."

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

   • Yes, in essence. The "Performance testing-Bench" and "Software Verification and Validation Testing" evaluate the device's inherent algorithms and functionality in a standalone manner (without a human in the loop for diagnostic interpretation, but rather for operational functionality and accuracy of physiological measurements). However, this is not in the context of a diagnostic AI algorithm.

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

   • Reference standards and engineering specifications. The "ground truth" for the non-clinical tests is derived from established international and national standards for medical electrical equipment, specific performance criteria for various physiological measurement modules, and the device's own accuracy specifications validated through bench testing.

7. The sample size for the training set:

   • Not applicable for a clinical training set. This is not an AI/ML device in the sense of learning from a large dataset of patient cases. The device's algorithms are designed and verified, not "trained" on patient data in a machine learning sense.

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

   • Not applicable. As above, no clinical training set or associated ground truth establishment process is described or relevant for this type of device submission.

In summary, the provided 510(k) focuses on demonstrating substantial equivalence through adherence to recognized performance and safety standards via non-clinical bench testing and software validation, rather than clinical studies involving human patients or complex AI diagnostic algorithms requiring expert review and adjudication.

Ask a specific question about this device

The iX series Patient Monitors including iX10, iX12, iX15 are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), and Anaesthesia gas (AG).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The NIBP monitoring supports iCUFS algorithm and iFAST algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatic patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients. The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.

This document describes the premarket notification (510(k)) for the Edan Instruments, Inc. Patient Monitor (iX10, iX12, iX15) and its equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device were generally established by compliance with various international standards for medical electrical equipment and specific performance characteristics. The reported device performance indicates that the device meets these standards and its specified accuracy.

For the Quick Temp Module (T2A), the provided text details specific clinical study results. Other parameters were tested for compliance with relevant standards through non-clinical testing.

2. Sample Size for Test Set and Data Provenance

For the Quick Temp Module (T2A) Predict Mode clinical accuracy study:

• Sample Size: 142 valid cases for sublingual and axillary temperature measurements.
• Data Provenance: Clinical investigation (prospective study). No country of origin is explicitly stated, but the company is based in China.

For other parameters, specific sample sizes for non-clinical (bench) testing are not provided, but the document states "Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards."

3. Number of Experts and their Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study of the Quick Temp Module (T2A). It only mentions that the study compared the new module against the "direct mode of F3000 Temp Module of M3A Vital signs monitor," implying the predicate device served as a reference for accuracy.

For other non-clinical tests, the ground truth is implicitly defined by the specifications and performance requirements outlined in the referenced international standards.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the clinical study or any other test sets.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a patient monitor, and its performance evaluation typically focuses on the accuracy and reliability of its physiological parameter measurements, not on improving human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance was evaluated for the components of the device. The non-clinical data section describes extensive functional and system-level testing to validate the performance against relevant consensus standards. This includes specific tests for algorithms like cardiac rhythm and ST segment measurement. The clinical study for the Quick Temp Module (T2A) also assesses the standalone performance of that specific module.

7. Type of Ground Truth Used

• For the Quick Temp Module (T2A) clinical study: The ground truth was established by comparison to a reference device's direct temperature measurement mode ("direct mode of F3000 Temp Module of M3A Vital signs monitor"). This is a form of reference standard comparison (using a predicate device as the reference).
• For other parameters (e.g., ECG, NIBP, SpO2, CO2, AG): The ground truth for non-clinical testing is implicitly based on the specifications and performance requirements outlined in the referenced international consensus standards (e.g., IEC 60601 series, ISO 80601 series, AAMI standards).

8. Sample Size for the Training Set

The document does not provide information about a training set since this is a patient monitoring device and not a machine learning algorithm as typically understood in the context of large-scale image-based diagnostics. The "algorithms" mentioned (e.g., arrhythmia detection, NIBP algorithms) are likely engineered signal processing algorithms rather than deep learning models requiring large training datasets.

9. How Ground Truth for Training Set was Established

Not applicable, as no training set for a machine learning model is described in the provided text. The algorithms for the patient monitor's functions are developed and validated against established physiological principles and engineering standards.

Ask a specific question about this device

The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).

Physiological parameters and waveforms supported are:

• Pulse oximetry (SpO2/pulse rate)
• Respiration rate (RR)

Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.

The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

This device is not an Apnea monitor (i.e., do not rely on the device for detection of alarm for the cessation of breathing).

This device should not be used for life sustaining/supporting purposes.

The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment.

The Portrait Mobile Monitoring Solution V1.1 is a wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages.

The Portrait Mobile Monitoring Solution V1.1 consists of the following general categories of medical devices:

Central Monitoring Devices:

• Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems.
• Portrait Central Viewer Application software hosted on a Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients.
• Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer.

Mobile Monitoring Devices:

• Portrait Mobile Patient Monitor Hardware, a battery-powered, wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor including alarms, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). Compared to the predicate (K230626), the Portrait Mobile Patient Monitor has been split into separate hardware and software components for serviceability. The Portrait Mobile Patient Monitor Hardware is shipped with no clinical software installed. The clinical software (i.e., Portrait Mobile Patient Monitor Software) is installed at the customer site before the device is put into use. The Portrait Mobile Patient Monitor Hardware when the Portrait Mobile Patient Monitor Software is installed (prior to patient use) is then what we will refer to as the Portrait Mobile Patient Monitor. Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly.
• Portrait Mobile Patient Monitor Software is the clinical software which gets installed at the customer site on the Portrait Mobile Patient Monitor Hardware. The Portrait Mobile Patient Monitor Software is this submission is equivalent to the software installed on the predicate Portrait Mobile Patient Monitor cleared in K230626 with minor changes as discussed in this submission.
• Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly.
• Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor.
• Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use).
• Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist
• Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in a table format. It focuses on demonstrating substantial equivalence to a predicate device, K230626 Portrait Mobile Monitoring Solution v1.0, through non-clinical testing and updates to software and standards compliance.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in a table format in the given document. The document lists "Specifications" for the proposed device and compares them to the predicate device, stating "Identical" or "Equivalent" for most technical specifications and performance characteristics, rather than specific acceptance criteria and detailed performance results from a study.

A table comparing the proposed device specifications to the predicate device is provided on pages 19-27, with "Identical" or "Equivalent" noted for each entry. The key takeaway is that the proposed device maintains the performance characteristics of the predicate.

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

The document mentions "Bench testing related to software, hardware and performance" but does not specify sample sizes for test sets.

• Sample Size for Test Set: Not specified for individual performance tests.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective for the non-clinical tests. It focuses on compliance with FDA guidance and recognized standards.

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

This information is not provided in the document for the non-clinical performance and validation tests mentioned. The document describes compliance with standards and guidance documents but does not detail the process of establishing ground truth for testing data, nor the number or qualifications of experts involved in such a process.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This type of study is not mentioned in the document. The submission explicitly states: "The Portrait Mobile Monitoring Solution v1.1 does not contain clinical testing data."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The document describes "SpO2 measurement," "Pulse Rate (PR) measurement," and "Impedance Respiration" for which "no changes have been made to the algorithms since K230626, only regression testing performed." This implies that the algorithms for these measurements are operating in a standalone capacity (device only), and their performance compared to the predicate device has been affirmed through regression testing. However, no specific standalone performance metrics or studies are detailed beyond this.

7. Type of Ground Truth Used

For the SpO2 and Pulse Rate measurements, the document mentions:

• "low perfusion condition (this testing covers the full accuracy range in challenging low-perfusion conditions using a simulator, proving that there has been no system regression)"

This indicates that simulators were used to establish reference data for certain conditions (low perfusion) for SpO2 and PR. For other measurements, the ground truth methodology is not explicitly specified beyond compliance with recognized standards.

8. Sample Size for the Training Set

This information is not provided. The document states that "no changes have been made to the SpO2 algorithms since K230626, only regression testing performed" and similarly for Respiration Rate algorithms. This suggests the underlying algorithms were developed and potentially trained earlier, but details of training data are absent.

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

This information is not provided, as details about training sets are omitted.

Ask a specific question about this device

Intended Use:

The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use:

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 only for use on one patient at a time.

The monitors are 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.

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 quide 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 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

All features and technological characteristics of the primary predicate IntelliVue Patient Monitors MX750 (866471), MX850 (866470) and IntelliVue 4-Slot Module Rack FMX-4 (866468) remain unchanged and are still applicable to the IntelliVue Patient Monitors, subject of this submission.

The proposed modifications for the IntelliVue Patient Monitors MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4 include:

• 1. A new software version, designated as IntelliVue Software P.01. The new software version introduces following new features:
  • . New alarm sounds designated as "Philips 2021" sounds, based on a joint development of Philips and Sen Sound researchers who focus on transforming the experience of sound in healthcare.
  • . New Visual Patient feature, which displays patients's vital signs in an animated patient avatar alongside the conventional vital sign waveforms and numerics.
  • . configurable alarm management, limiting changes in alarm settings to pre-defined authorized personnel.

It further enhances following existing features

• Manual Selection of QRS /Pulse Tone
• Introduction of Lead Diagram for ECG
• . Enhancement of Visual Presentation for "Global Alarm Off" State

This document describes the Philips IntelliVue Patient Monitor MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4. The submission references a prior clearance (K221348) as the primary predicate device, indicating that the current submission is for modifications to an existing device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for performance in a table format with numerical values. Instead, it details that the device passed various tests related to electrical safety, EMC, wireless coexistence, software integration, software functionality within the system, essential performance, and human factors. The acceptance criterion for each of these tests is implied to be "PASSED" against recognized consensus standards and internal requirements.

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

The document does not specify the sample sizes used for any of the tests mentioned (e.g., how many devices were tested for electrical safety, or how many users were involved in human factors testing). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of these non-clinical tests.

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 in the document. The tests described are primarily engineering and software validation tests rather than clinical studies requiring expert ground truth for interpretation. For "Human Factors," it would involve users, but their qualifications and numbers are not detailed.

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

This information is not provided. The nature of the tests (compliance with standards, software functionality) suggests that a formal adjudication method like 2+1 or 3+1 for ground truth establishment, typical in clinical studies, would not be applicable here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a patient monitor with software enhancements, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

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

The document indicates "Software Testing" was performed, which would involve testing the algorithms and functionalities of the software in a standalone manner. However, it's not a standalone diagnostic algorithm in the typical sense; it's the core operating software of the patient monitor. The new features like "new alarm sounds," "Visual Patient feature," and "configurable alarm management" were tested for their functionality and integration.

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

The "ground truth" for the tests described is primarily based on:

• Recognized consensus standards: For electrical safety (IEC 60601-1, IEC 60601-1-8, IEC 62304), EMC (IEC 60601-1-2).
• System requirements/specifications: For software integration, software functionality, and essential performance.
• Usability principles: For Human Factors testing.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth, as these are non-clinical hardware and software validation tests.

8. The sample size for the training set:

This information is not applicable as this document does not describe an AI or machine learning model that requires a training set. The changes described are software updates for existing functionalities and introduction of new display/alarm features, not the development of a predictive algorithm from data.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring devices, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.

The Patient Monitoring Cables are replacements for similar accessory cables manufactured or specified by Original Equipment Manufacturers (OEM) for their respective transducers, monitors, and peripheral equipment. These are non-patient-contact, insulated, electrical cables with a connector (plug or receptacle) at each end, designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect SpO2 sensor, IBP transducer to a patient monitor). They are not intended to connect to the mains (i.e., not mains power cables), do not generate any type of power and/or signal, and have no additional non-electrical conducting or processing functionality.

The provided text describes a 510(k) premarket notification for "Fogg System Patient Monitoring Cables." This document focuses on the substantial equivalence of the cables to a predicate device based on bench testing of physical and electrical properties, not on a clinical "study" involving AI or human-in-the-loop performance. Therefore, many of the questions related to AI device performance evaluation (such as MRMC studies, training set details, and expert ground truth establishment for AI) are not applicable to this submission.

Here's a breakdown of the acceptance criteria and the "study" (nonclinical test data) presented in the document:

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

The document does not present a formal table of acceptance criteria with corresponding performance results. Instead, it states that the Fogg System Patient Monitoring Cables "met all acceptance criteria from the testing and analyses". The testing and analyses performed were:

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

• Sample Size: The document mentions "worst case representative cable assemblies and cable material" were used for performance testing. It does not provide a specific number for the sample size.
• Data Provenance: The testing was "nonclinical" and performed on the physical devices/materials. The document does not specify a country of origin for the data, but given it's a US FDA submission, it's implied that the testing was conducted in a manner acceptable for US regulatory purposes. The testing is not retrospective or prospective clinical data; it's laboratory bench testing.

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

This question is not applicable. The "ground truth" for this type of device (patient monitoring cables) is established by engineering specifications, international standards (IEC 60601, AAMI/ANSI BP22), and established testing methodologies for electrical and material properties, not by human expert review of clinical cases or images.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, often involving expert readers. For physical device testing, the "ground truth" is determined by whether the device's electrical and material properties meet established engineering and safety standards. There is no human adjudication process described for this type of nonclinical testing.

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

This question is not applicable. This submission is for patient monitoring cables, which are passive accessories, not an AI-powered diagnostic device. No MRMC study was conducted.

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

This question is not applicable. This submission is for patient monitoring cables, not a standalone AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and adherence to recognized international standards such as IEC 60601 and AAMI/ANSI BP22 for patient transducer and electrode cables. It is a technical ground truth related to electrical continuity, signal integrity, electromagnetic compatibility, and material properties, not clinical outcomes or expert consensus on clinical data.

8. The sample size for the training set

This question is not applicable. There is no AI component requiring a training set for this device.

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

This question is not applicable. As there is no AI component, no training set or its ground truth was established for this submission.

Ask a specific question about this device

Intended Use:

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.

Indication for Use:

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

The monitor is only for use on one patient at a time. The monitor is not a therapeutic device. Caution: 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 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 Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only.

Warning: 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 nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

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 the hospital environment. It is not intended for home use.

Warning: The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).

Contraindications: There are no known contraindications for the IntelliVue MX100/X3 Patient Monitor/Multi-Measurement Module.

The Multi-Measurement Module X3 and the IntelliVue Patient Monitor MX10
0, 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 devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals. The X3 and MX100 can interact with the Central Station via LAN or wireless link.

The Multi-Measurement Module X3 and IntelliVue Patient Monitor MX100 are compact, rugged, lightweight monitors with built-in invasive and non-invasive measurements, namely ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2. It can further extend the measurement capabilities when connecting to the legally marketed IntelliVue Multi-Measurement Extensions

The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor.

The provided document, an FDA 510(k) summary for the Philips IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3, describes a device that has undergone technical modifications, primarily software updates, rather than being a novel AI-powered diagnostic or assistive tool.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered diagnostic device, a study proving it meets those criteria, sample sizes for test and training sets, expert usage for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device, as per FDA 510(k) requirements. This typically involves showing that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Here's why the requested information is absent and what is discussed:

1. Acceptance Criteria for AI Performance and Reported Performance: Not applicable as this is not an AI diagnostic device. The acceptance criteria mentioned are related to compliance with general medical device safety and performance standards (e.g., electrical safety, EMC, software lifecycle, usability, alarm systems).
2. Sample Sizes and Data Provenance: Not applicable for AI model testing. The document states "No new issues of safety or effectiveness as compared to the predicate are introduced because of using this device," indicating that the focus was on validating the software changes within the existing framework of a patient monitor, not on an AI algorithm's diagnostic performance on a specific dataset. There is no mention of a "test set" in the context of AI performance.
3. Number of Experts and Qualifications: Not applicable. Ground truth establishment for AI models is not relevant to this submission.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The device is a patient monitor, not an AI-assisted diagnostic tool that would improve human reader performance.
6. Standalone Algorithm Performance: Not applicable. There is no standalone AI algorithm being assessed.
7. Type of Ground Truth: Not applicable in the context of AI. The "ground truth" for this device would be the accurate measurement of physiological parameters (e.g., ECG, SpO2, NBP), which is assessed through bench testing and compliance with recognized standards, not "expert consensus" or "pathology" in the AI sense.
8. Sample Size for Training Set: Not applicable. There is no AI model training described.
9. How Ground Truth for Training Set Was Established: Not applicable.

What the document does demonstrate (in lieu of AI performance data):

The document primarily focuses on software changes and the continued compliance with established medical device standards to prove substantial equivalence:

• Software Changes: The key difference from the predicate device is a new software version (P.01) introducing new alarm sounds, configurable alarm management, enhancing Early Warning Score Validation, additional SpO2 fallback configuration, additional Lead Diagram presentation for ECG, and enhancement of the global "alarm off" state.
• Non-Clinical Bench Tests and Harmonized Standards: The device has passed safety tests demonstrating compliance with recognized standards like ANSI AAMI ES60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 60601-1-8 (Alarm Systems), and IEC 62304 (Medical device software lifecycle).
• No Clinical Studies: The submission explicitly states, "The subject devices, like the primary predicate devices, did not require clinical trials." This further indicates that the changes were not considered to introduce new safety or effectiveness concerns requiring human subject data for validation.
• Substantial Equivalence: The conclusion is that the modified devices "do not raise different questions of safety and effectiveness when compared to the predicate, perform as intended, and have performance characteristics that are substantially equivalent to the predicate devices."

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 only for use on one patient at a time.

The monitors are 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 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 Intelli Vue 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 nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use 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 MX400, MX450, 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, heart rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, 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 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.

This document is a 510(k) Summary for the Philips IntelliVue Patient Monitor MX400, MX450, MX500, and MX550. It does not describe a study involving an AI/algorithm that requires detailed acceptance criteria, ground truth establishment, or specific human reader studies as typically seen for AI-enabled medical devices. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to software and hardware modifications allowing integration with external measurement devices like the Masimo SedLine Sedation Monitor.

Therefore, many of the requested points, particularly those related to AI/algorithm performance studies (e.g., sample size for test set/training set, expert adjudication, MRMC studies, standalone performance, specific effect sizes), are not applicable to this type of 510(k) submission.

However, I can extract information related to the overall device performance and testing as described in the document.

Here's an analysis of the provided text in relation to your request, with an emphasis on what is and is not present:

Device: IntelliVue Patient Monitor MX400, MX450, MX500, MX550

Study Type: This is a 510(k) premarket notification primarily demonstrating substantial equivalence (predicate pathway) for modifications to an existing patient monitor, specifically related to software updates and integration of an external monitoring module (Masimo SedLine Sedation Monitor). It is not a de novo submission for a new AI/algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria for an AI/algorithm's performance (e.g., accuracy, sensitivity, specificity metrics) nor does it provide a "reported device performance" table in that context.

Instead, the "acceptance criteria" can be inferred from the non-clinical tests performed to demonstrate compliance with recognized standards for medical electrical equipment. The "reported device performance" is that the device "passed all safety tests" and "perform as intended."

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

• Test Set Sample Size: Not applicable/not specified for an AI/algorithm test set. The testing described is primarily for system-level safety, performance, and software validation.
• Data Provenance: Not applicable in the context of an AI/algorithm dataset. The document discusses compliance with various electrical, safety, software, and usability standards for the device itself.

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

Not applicable. Ground truth establishment by experts is typically for diagnostic AI/imaging algorithms. This submission is for a patient monitor system.

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

Not applicable. Adjudication methods are relevant for expert review of images or clinical data for AI algorithm validation.

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 device is a patient monitor, not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate human reader performance with or without AI assistance.

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

Not applicable. This is not an AI/algorithm in the sense of a diagnostic or predictive model being evaluated in standalone mode. It's a medical device system. While it has "software," the performance evaluation is centered on its functionality as a patient monitor and its compliance with relevant standards.

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

Not applicable. The "ground truth" for this device's performance validation is its ability to correctly acquire, display, and alert on physiological parameters according to established benchmarks and safety standards (e.g., AAMI EC11 for ECG, IEC standards for electrical safety). It's not a diagnostic AI's ground truth based on clinical diagnoses or pathological findings.

8. The sample size for the training set

Not applicable. This is not an AI/ML model generated from a training set in the typical sense of deep learning or machine learning algorithms.

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

Not applicable. (See #8)

Summary of what the document does discuss regarding validation and performance:

The document emphasizes non-clinical bench tests and compliance with harmonized standards (e.g., IEC 62304 for software, ANSI AAMI ES60601-1 for basic safety, IEC 60601-1-8 for alarms, IEC 60601-1-6 for usability). The "performance data" section primarily lists these standards and states that the devices "passed all safety tests."

Key statements from the document regarding performance:

• "The subject devices have passed all safety tests for demonstrated compliance with the recognized standards below." (See table in section 1.8 Performance Data)
• "No new issues of substantial equivalence are introduced because of using this device." (Section "Non-clinical Bench Tests")
• "The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo SedLine parameter are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor." (Section "Clinical Studies")
• "Compliance to the FDA Quality System Regulations, FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the subject devices." (Section "Clinical Studies")
• "The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation, human factors, usability and interoperability testing, demonstrate that the modified devices do not raise different questions of safety and effectiveness when compared to the predicate, perform as intended, and have performance characteristics that are substantially equivalent to the predicate devices." (Section 1.9 CONCLUSIONS)

In conclusion, this 510(k) submission for the Philips IntelliVue Patient Monitor MX series primarily relies on demonstrating compliance with recognized electrical safety, performance, and software development standards, along with a comparison to predicate devices, rather than an AI/algorithm performance study with specific metrics, expert adjudication, or MRMC studies.

Ask a specific question about this device

The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).

Physiological parameters and waveforms supported are:
· Pulse oximetry (SpO2/pulse rate)
· Respiration rate (RR)

Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.

The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

This device is not an Apnea monitor (i.e., do not rely on the device for the cessation of breathing). This device should not be used for life sustaining/supporting purposes.

The Portrait Mobile Monitoring Solution is not in a controlled Magnetic Resonance (MR) environment.

Portrait Central Viewer Application (Portrait CVA01):
The Portrait Central Viewer Application (Portrait CVA01) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications.

The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait Core Services (Portrait CSS01):
The Portrait Core Services are a set of software services that enable the communication of the Portrait Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Monitoring Solution.

Portrait Clinical Alarming Unit (Portrait CAU01):
The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability.

The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait Mobile Patient Monitor (Portrait HUB01):
The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from body-worn sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The device can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services.

The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Wearable Pulse Oximetry Sensor P-SA01 (Portrait SpO2 P-SA01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait SpO2 Attachment Accessory Band (Portrait AAB01):
The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.

The Portrait Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01):
The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediativ (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait RR Electrode Patch (Portrait RRP01):
The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The electrode patch transfers carrier signals from the wearable respiration rate sensor and transfers impedance and biopotential signals from the patient and transmits them to the wearable respiration rate sensor.

The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait RR Electrode Patch is not in a controlled Magnetic Resonance (MR) environment.

Portrait Sensor Battery (Portrait SBT01):
The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait wearable sensors and to provide wireless communication to a host device.

The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Bedside Charger (Portrait BCH01):
The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use).

The Portrait Bedside Charger is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Mobile Patient Monitor Pouch (Portrait MMP01):
The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is an optional accessory intended to enable the Mobile Patient Monitor to be carried while the patient is ambulatory.

The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Mobile Monitoring Solution is a new wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages. This device is not an Apnea monitor (i.e., do not to rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. Do not attempt to use this device to detect sleep apnea.

The Portrait Mobile Monitoring Solution consists of the following general categories of medical devices:

Central Monitoring Devices:
Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems.

Portrait Central Viewer Application software hosted on a . Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients.

. Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer.

Mobile Monitoring Devices:
Portrait Mobile Patient Monitor, a battery-powered, . wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor including alarming, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). . Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly. . Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly. . Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor. . Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use). . Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist. . Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the GE HealthCare Portrait Mobile Monitoring Solution.

Here's an analysis structured according to your request:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for the Portrait Mobile Monitoring Solution are primarily based on performance specifications for its physiological parameters (Respiration Rate, SpO2, Pulse Rate) and its compliance with relevant medical device standards. The document provides comparison tables indicating how the proposed device's performance aligns with or is considered equivalent to predicate devices.

Key Performance Specifications and Reported Performance:

Ask a specific question about this device