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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:

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The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility.

The CARESCAPE SpO2 – Masimo is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patient at a time.

The CARESCAPE SpO2 – Masimo is indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.

The Masimo CARESCAPE SpO2 – Masimo with SpHb ("CARESCAPE SpO2 – Masimo") is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to continuously monitor Masimo pulse oximetry parameters (SpO2, PR, and SpHb). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

The CARESCAPE SpO2 – Masimo is the same module cleared as the GE CARESCAPE SpO2 – Masimo as part of the secondary predicate device (K213234), which provides the Masimo SET and rainbow SET Technology for the measurement and monitoring of pulse oximetry data. The only difference between the two modules is that the subject device is labeled for distribution by Masimo, and the secondary predicate is labeled for distribution by GE Healthcare. The difference between the subject device and primary predicate is the activation of the SpHb feature, the same as what was cleared as part of the secondary predicate (K213234).

This document is a 510(k) premarket notification for the "Masimo CARESCAPE SpO2 - Masimo with SpHb" device. The submission claims substantial equivalence to previously cleared predicate devices (K212876 and K213234). The primary change in the subject device is the activation of the SpHb (total hemoglobin concentration) feature, which was already cleared as part of the secondary predicate (K213234).

Therefore, the performance data presented is largely a restatement of the specifications of the equivalent devices, rather than new testing specific to this submission.

Here's a breakdown of the requested information based on the provided text:

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

The acceptance criteria are the performance specifications for accuracy (Arms - Accuracy Root Mean Squared) listed in Table 1 and Table 4-1. The reported device performance is indicated as meeting these specifications by virtue of being the same device as the predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "As there were no performance changes made to the subject device from its latest clearance as part of the CARESCAPE ONE (K213234), no performance bench testing was included in this submission." This indicates that no new performance testing was conducted for this specific submission (K221953) to establish the device's performance directly. The performance specifications are derived from previous clearances of essentially the same device. Therefore, the sample size and data provenance for the original studies that established these specifications are not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text, as no new performance testing was conducted for this submission. The performance claims rely on prior clearances.

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

This information is not available in the provided text, as no new performance testing was conducted for this submission.

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

The device is an oximeter for continuous non-invasive monitoring of SpO2, PR, and SpHb. It is not an AI-assisted diagnostic device, nor does it involve human "readers" or image interpretation. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was performed or reported.

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

The device's performance specifications (e.g., Arms accuracy) are akin to a "standalone" performance, in the sense that they describe the accuracy of the device's measurements compared to a reference standard, without human interpretation as part of the primary measurement. The document states that the physical module and its underlying Masimo SET and rainbow SET Technology are the same as previously cleared. So, the stated performance specifications are effectively the standalone performance of the device's algorithms for SpO2, PR, and SpHb. No new standalone testing was conducted for this submission, relying on previous clearances.

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

For oximeters, the ground truth for SpO2 and SpHb measurements is typically established through direct blood gas analysis (e.g., co-oximetry) from arterial blood samples. The document does not explicitly state the ground truth method but this is the standard for such devices. This information also would have been detailed in the original submissions for the predicate devices.

8. The sample size for the training set

This is not applicable as the document does not describe the development or training of an AI algorithm or a "training set" in that context. The device relies on established physiological principles and signal processing techniques (Masimo SET and rainbow SET Technology).

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

This is not applicable as the document does not describe the development or training of an AI algorithm or a "training set" in that context.

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The CARESCAPE™* CO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines. The CARESCAPE™* CO2 - Microstream™ parameter is intended for use in hospital-type facilities, during intra-hospital transport between and within areas of care.

The GE CARESCAPE™* CO2 -Microstream™ parameter is a module utilizing Microstream™ Capnography technology designed for use with specific GE Host monitors (CARESCAPE™* ONE. CARESCAPE™* B450 [K213234]. CARESCAPE™* B650 [K213181]. or CARESCAPE™* B850 [K213336]). The GE CARESCAPE™* CO2 -Microstream™ parameter comprised of two main sub-systems: - Microstream™ NanoMediCO2 is a Capnography module in its plastic enclosure called . the NanoPod, responsible for measuring the inspired carbon dioxide and respiration rate of adults, pediatric patients, and neonatal patients, - . U-MCO2-active cable module in its enclosure (called "Active cable" or "Bridge" or "Common block") responsible for enabling the bidirectional communication between the Host monitor and the NanoMediCo2 module, using the specific GE communication protocol (Taq-Length-Data). The Active Cable also acts as a power supply to the NanoPod, transferring power from the host to the pod and provides the user with an indication of the Pod's functional status. The NanoPod mates on one side with the Microstream™ Advance Filter Lines. On the other side the NanoPod attaches to GE patient monitoring system via the U-MCO2- active cable, allowing them to display the Microstream™ Capnography parameters. The U-MCO2 active cable module, is connected to an interface board located inside the active device (NanoPod), while on the other side of the U-MCO2 active cable, there is a proprietary GE (Amphenol) connector, designed to connect solely with GE Healthcare monitors. The NanoPod is activated by Microstream™ Advance Filter Lines that are connected through the blue door located on the upper side of the NanoPod.

The provided text describes the regulatory clearance of a medical device, the CARESCAPE™ CO2 - Microstream™ parameter, and its substantial equivalence to a predicate device. However, it does not include the detailed information required to fulfill the request about acceptance criteria and a study proving the device meets them.

Specifically, the document states:

• "The functional features and the indications for use of the CARESCAPE™ CO2 - Microstream™ parameter are substantially equivalent to the predicate device."
• "The CARESCAPE™ CO2 - Microstream™ parameter has successfully undergone performance, safety, electromagnetic and environmental testing to ensure compliance with expected performance standards."
• "Software testing was performed to validate the performance of the CARESCAPE™ CO2 - Microstream™ parameter and its substantial equivalence to the predicate device."
• "Animal Performance Testing: Not applicable. Animal performance testing was not necessary to show substantial equivalence."
• "Clinical Performance Testing: Not applicable. Clinical evidence was not necessary to show substantial equivalence."

This indicates that the key evidence for this device's performance relies on bench testing and software testing, demonstrating equivalence to a previously cleared device, rather than a de novo clinical study with specific acceptance criteria for a new mode of action or clinical outcome.

Therefore, I cannot provide the requested information about acceptance criteria, detailed study design (sample sizes, ground truth establishment, expert involvement, MRMC studies, etc.). The document explicitly states that animal and clinical performance testing were not necessary to show substantial equivalence, and no such study details are provided.

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