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The INFINITY Modular monitors are capable of monitoring: Heart rate, Respiration rate, Invasive pressure, Non-invasive pressure, Arrhythmia, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate, Apnea, ST Segment Analysis, 12-Lead ST Segment Analysis, tcp02/tcpC02, EEG signals, FiO2. The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors. With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via a MIB protocol converter.

Siemens INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The SCIO module samples breathing gases from adults and pediatrics. SCIO continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents: halothane, isoflurane, enflurane, sevoflurane, and desflurane in any mixture. When SCIO is connected to an INFINITY Modular monitor it communicates real time and derived gas information to the monitor for display.

This 510(k) premarket notification for the INFINITY Modular Monitors with SCIO module focuses on substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria for a new AI/software-as-a-medical-device (SaMD) product. Therefore, many of the requested categories related to AI/SaMD performance studies and ground truth establishment are not applicable.

The document primarily demonstrates that the new device, which continuously measures various breathing gases and anesthetic agents, has the same intended use and technological characteristics as legally marketed predicate devices.

Here's the breakdown of the information that can be extracted from the provided text, and where specific requested details are not applicable:

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

This information is not provided in the 510(k) summary. The summary states "Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)" and "Assessment of clinical performance data for equivalence: Substantially equivalent (Section U)". This indicates that performance data was reviewed to establish equivalence to predicate devices, but the specific acceptance criteria and detailed performance metrics are not included in this summary document. For a traditional medical device like a patient monitor, acceptance criteria would typically involve accuracy, precision, response time, alarm functionality, and other physiological measurement parameters compared to established standards or a predicate device.

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

This information is not provided. The 510(k) summary refers to "non-clinical performance data" and "clinical performance data" but does not detail the specifics of any test sets, sample sizes, or data provenance.

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 applicable/not provided. For a device like a physiological monitor measuring gas concentrations, ground truth would typically be established by highly accurate reference measurement devices, not by human experts. The 510(k) summary does not describe a study involving expert-established ground truth.

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

This information is not applicable/not provided. Adjudication methods are typically relevant for studies where human interpretation (e.g., image reading) contributes to ground truth establishment, which is not the case for this type of device.

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 information is not applicable/not provided. This is not an AI/SaMD product that assists human readers. It's a physiological monitor.

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

This information is not applicable/not provided. The device is a physiological monitor, not an algorithm being tested in a standalone capacity separate from the human operator. Its function is to provide direct measurements and alarms.

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

This information is not explicitly stated, but for a device measuring gas concentrations, the ground truth would typically be established by highly accurate laboratory-grade gas analyzers or calibrated reference standards.

8. The sample size for the training set

This information is not applicable/not provided. This is a physiological monitor, not a machine learning or AI device that requires a "training set" in the conventional sense. Its functionality relies on sensing and processing physical signals based on established scientific principles.

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

This information is not applicable/not provided for the same reasons as point 8.

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The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.

The INFINITY Modular monitors are capable of monitoring:

• Heart rate
• Respiration rate
• Invasive pressure
• Non-invasive pressure
• Arrhythmia
• Temperature
• Cardiac output
• Arterial oxygen saturation
• Pulse rate
• Apnca
• ST Segment Analysis
• 12-Lead ST Segment Analysis
• tcp02/tcpC02
• EEG signals
• FiO2

With the MultiGas and MultiGas+ modules the monitors are capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.

The monitors can interface with specific third party devices via an MIB protocol converter.

The modifications implemented with the release of software version VF2 have not altered the basic fundamental technology of the INFINITY Modular Monitors. Testing with VF2 software indicates no new issues relative to safety and efficacy. The release of software version VF2 includes the following primary modifications:

• 1. Wireless capability
• Non-invasive blood pressure with step deflation 2.
• 3. MICRO2+(K012770) interface
• Support for Masimo sensors 4.

The INFINITY Modular Monitors (SC 7000 / SC 9000XL) with Wireless Option (a password protected option) allows the monitor to operate in a wireless network configuration. A wireless ethernet adapter installed in the PCMCIA port communicates with the INFINITY Network (K955059) through installed access points hardwired to the network. All patient related and network data is transmitted to the pre-installed access points allowing the transmitted data from the monitor to be viewed at an assigned MultiView WorkStation (K955059). This configuration provides the network with the same functionality as a hardwired system.

The Infinity Monitoring System utilizes the oscillometric method to measure noninvasive blood pressure (NIBP). With the SC7000/8000/9000XL VF2 release, the NIBP algorithm has changed from a linear to stepped deflation system.

The INFINITY Modular Monitor (SC 7000 / SC 8000 / SC 9000XL) VF2 release supports two simultaneous SpO2 measurements. Using a serial port already available on the monitors, the MicrO2+ pulse oximeter (K012770) can communicate with the monitors using a RS232 serial communication and power supply cable connected to the serial port on the monitor. The stand-alone MicrO2+ pulse oximeter transmits SpO2 and Pulse values to the monitor.

The monitor supports the use of Masimo SpO2 sensors via a password protected option and a specific adapter cable.

The provided text describes modifications to the Siemens INFINITY Modular Monitors and makes references to equivalence assessments and clinical accuracy studies. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

The document states:

• "Assessment of non-clinical performance data for equivalence: See Section J"
• "Assessment of clinical performance data for equivalence: See Section J"
• "Clinical accuracy studies referenced to cooximetry (see Section J) were conducted by Masimo using the following sensors in conjunction with the INFINITY Modular monitors"

Since "Section J" is not provided in the input, the specific details of the acceptance criteria and the studies proving the device meets them are unavailable.

Based on the available text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not provided in the given text.
• Reported Device Performance: Not provided in the given text, beyond the general statement that "Testing with VF2 software indicates no new issues relative to safety and efficacy."

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

• Sample Size: Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). The text only states "clinical accuracy studies referenced to cooximetry... were conducted by Masimo."

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

• Not provided. The text mentions "clinical accuracy studies referenced to cooximetry," implying cooximetry serves as a reference, but it doesn't specify if human experts were involved in establishing ground truth or their qualifications.

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

• Not provided.

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. The described device is a physiological monitor, not an AI-assisted diagnostic tool that human readers would use in a comparative effectiveness study. The text focuses on the device's ability to measure physiological parameters and its new features (wireless, NIBP, SpO2 interface, Masimo sensor support).

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

• The text implies standalone testing of the device's physiological measurement capabilities through "clinical accuracy studies referenced to cooximetry." However, details of these studies are not provided.

7. The type of ground truth used:

• For SpO2 measurements, the text explicitly states "clinical accuracy studies referenced to cooximetry." Cooximetry is a gold standard for measuring oxygen saturation in blood. For other parameters (Heart rate, Respiration rate, NIBP, etc.), the type of ground truth is not specified in this document.

8. The sample size for the training set:

• Not provided. The document describes modifications to an existing device and refers to "accuracy studies" but does not detail a training set for an AI/algorithm.

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

• Not provided, as details of a training set are not mentioned.

In summary, for a complete answer to your questions, "Section J" of the original 510(k) submission would be required. The provided excerpt only gives a high-level overview of the device modifications and mentions that performance data exists, but not the specifics of that data or the studies.

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