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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 an 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 .
• Apnea .
• ST Segment Analysis ●
• 12-Lead ST Segment Analysis
• tcn02/tcp(02 .
• EEG signals .
• FiQ2 .

The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure and produce real time and derived gas information of CO2, NO, 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 with etCO2 and instream 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 devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult population only, and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

The INFINITY Modular monitor VF4 software release includes a modification in support of the Scio gas module for dual-anesthetic agent display.

The provided document describes a Special 510(k) Notification for modifications to the INFINITY Modular MonitorsVF4 software release, specifically in support of the Scio gas module for dual-anesthetic agent display. This is a modification to an existing, legally marketed device, and the submission primarily focuses on demonstrating that the modified device is as safe and effective as the previous versions.

Therefore, the document does not contain information about the development and testing of a new AI/ML device that would typically involve acceptance criteria, performance metrics, ground truth establishment, or clinical studies involving human readers. Instead, it describes a verification and validation study to ensure that the modifications to the existing software and hardware do not introduce new safety or efficacy issues.

Here's an analysis based on the information provided, recognizing that the scope is for device modification rather than a new AI/ML product:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table. Instead, it refers to:

The implicit acceptance criterion is that the modified device performs similarly to or better than the predicate device without introducing any new safety or efficacy concerns. The "reported device performance" is a qualitative statement of conformity.

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 does not specify the sample size for any test set or the data provenance. It generally states that "verification and validation testing of VF4 software" was performed. Given this is a software modification for an existing monitor, the testing would likely involve simulation, bench testing, and potentially some form of in-house functional testing using synthetic or recorded physiological data, but no details are provided.

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 is not applicable to the type of submission described. "Ground truth" in the context of device performance, especially for AI/ML, refers to a definitive correct answer for a given input. For this type of physiological monitoring device modification, the "ground truth" would be the known physiological parameters (e.g., gas concentrations) used during testing, established by calibrated reference equipment, not by human experts.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret data, and there's a need to resolve discrepancies. This submission pertains to software and hardware modifications to a physiological monitor, not diagnostic image interpretation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where human interpretation is involved. The INFINITY Modular Monitors are physiological monitors that directly display parameters. The modifications relate to displaying dual-anesthetic agents.

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

The document implies that the device's performance (i.e., its ability to monitor and display physiological parameters) was assessed independently through "verification and validation testing." However, it does not explicitly use the term "standalone performance" in the context of an algorithm. The device itself, as a monitor, operates in a "standalone" fashion by measuring and displaying data, and the software modifications were tested to ensure this function remains effective.

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

The type of "ground truth" for a physiological monitor would typically be measurements from calibrated reference instruments or known physiological states (e.g., a gas mixture with a known concentration of anesthetic agents). The document does not explicitly state how ground truth was established, but it would be part of standard verification and validation procedures for such devices. For example, to test the accuracy of gas measurements, the Scio module would be exposed to precisely mixed gas samples with known concentrations, and the device's readings would be compared to these known values.

8. The sample size for the training set

Not applicable. This is a modification to an existing physiological monitor, not an AI/ML product that undergoes a training phase with a dataset.

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

Not applicable. As above, there is no training set mentioned or implied for this type of device modification.

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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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This device is capable of monitoring:

• Heart Rate .
• Respiration Rate .
• Invasive Pressure .
• Non-Invasive Pressure ●
• Arrhythmia .
• Temperature .
• Arterial oxygen saturation .
• Pulse rate .
• (central) apnea .
• end-tidal CO2 .
• ST Segment Analysis .

This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to Siemens R50 recorders, either directly or via the INFINITY network.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, e.g., Physicians, Nurses, and technicians, trained on the use of the devices, who will make the final assessment of the patient's medical condition.

SC 6002XL Wireless Option

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 MultiView WorkStation supports wireless operation by providing information to the SC6002XL allowing the monitor to have a unique network address. Once the SC6002XL has established itself on the network, the MultiView WorkStation has no new functionality. MultiView WorkStation hazards identified with the MVWS support of the wireless functionality have been addressed in MVWS VF2 software.

SC 6002XL with Full Arrhythmia Option

The SC 6002XL VF1 release includes the Full Arrhythmia Option. With this option eight additional arrhythmia calls are enabled. The arrhythmia algorithm is the same algorithm found in Siemens MVWS INFINITY Telemetry (K003179), as well as Siemens patient monitors, including: SC 7000 / SC 9000XL (K980882) and SC 8000 (K983632). Previous releases of the SC 6002XL (K993974 DC 900012 (1196002) the same arrhythmia algorithm, however, in the first two releases of the SC and I would the Basic Arrhythmia functionality, with fewer arrhythmia calls was made available.

Fourth Channel Option

In addition, to provide customers with more readily available information, a fourth channel is being made available. The fourth channel is also a locked option.

The provided document is a 510(k) summary for the Siemens INFINITY SC 6002XL Modifications. It details the device, its intended use, and indicates the basis for its substantial equivalence determination to previously marketed predicate devices. However, it does not include detailed information about specific acceptance criteria, a study proving performance against those criteria, or the methodology (like ground truth establishment, sample sizes for training/testing, or expert qualifications) that would typically be found in a clinical or performance study report.

Here's a breakdown of the information that can be extracted and, crucially, what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the given document. The document states "Assessment of non-clinical performance data for equivalence: Section L" but does not elaborate on the specific criteria or the results of this assessment. For clinical performance, it explicitly states "Assessment of clinical performance data for equivalence: Not applicable."

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

This information is not provided. Since no clinical performance study is described, there's no mention of a test set, its sample size, or data provenance.

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. As no clinical performance study is described with a test set, there is no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set:

This information is not provided. Since no test set is described, there is no adjudication method mentioned.

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

This information is not provided. The document makes no mention of an MRMC study or any AI assistance. The device is a physiological monitor, not an AI-driven image interpretation or diagnostic aid that would typically involve human readers.

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

This information is not explicitly stated as a standalone performance study in the document. The document refers to the arrhythmia algorithm being "the same algorithm found in Siemens MVWS INFINITY Telemetry (K003179), as well as Siemens patient monitors, including: SC 7000 / SC 9000XL (K980882) and SC 8000 (K983632)." This implies that the algorithm's performance was evaluated in the context of those previous submissions, but documentation for that specific evaluation is not part of this 510(k) summary.

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

This information is not provided for any specific study in this document.

8. The sample size for the training set:

This information is not provided. The document does not describe a training set as it pertains to an AI/ML algorithm being developed or refined.

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

This information is not provided.

Summary of what the document does provide regarding the device's basis for market clearance:

The document focuses on demonstrating substantial equivalence to previously cleared devices (predicates) rather than providing a detailed de novo clinical performance study report.

• Predicate Device: Siemens INFINITY SC 6002XL (K993974, K002105) and the arrhythmia algorithm from Siemens MVWS INFINITY Telemetry (K003179) and other Siemens patient monitors (SC 7000/SC 9000XL K980882, SC 8000 K983632).
• Modifications: The 510(k) submission addresses modifications to the existing INFINITY SC 6002XL, specifically:
  • Wireless Option: Adding a wireless ethernet adapter for network connectivity. The functionality is stated to be "the same functionality as a hardwired system."
  • Full Arrhythmia Option: Enabling eight additional arrhythmia calls using an existing, previously cleared arrhythmia algorithm found in other Siemens devices.
  • Fourth Channel Option: Providing a fourth channel of information.
• Assessment of Equivalence:
  • Non-clinical performance data: Referenced as "Section L," but details are not provided in this summary.
  • Clinical performance data: Stated as "Not applicable," indicating that for these specific modifications, new clinical data was not deemed necessary by the submitter to demonstrate substantial equivalence, likely due to the use of a previously cleared algorithm and the nature of the wireless and fourth-channel additions.
• Standards: IEEE 802.11 Standard for Wireless Medium Access Method (MAC) and Physical Layer (PHY) is listed, suggesting that the wireless component's performance would be evaluated against this standard.

In essence, the document asserts that the modified device is substantially equivalent to existing, legally marketed devices based on the inclusion of proven components (like the arrhythmia algorithm) and standard compliant technologies (like wireless networking), without presenting new, detailed performance study outcomes for these specific modifications.

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This device is capable of displaying physiological parameters received from INFINITY monitors (SC 7000, SC 8000, SC 9000XL) and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The device is intended for use with the adult, pediatric and neonatal populations.

The INFINITY EXPLORER is a critical care workstation that acts as a display for physiological parameters received from an INFINITY patient monitor (SC 7000/SC 8000/SC 9000XL). Parameters are displayed (audio alarming and flashing visual indications are provided on the INFINITY patient monitor screen).

INFINITY EXPLORER utilizes the syngo (510k K010938) software platform and user interface common to other Siemens Medical modalities. INFINITY EXPLORER with syngo software is capable of displaying DICOM images retrieved from a syngo compatible image archive. A Task Card provides access to DICOM images.

The Siemens INFINITY EXPLORER is a critical care workstation intended to display physiological parameters from INFINITY patient monitors and visually display alarm data. It is also capable of displaying DICOM images.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table. Instead, it relies on a comparison to predicate devices and general statements about safety and effectiveness.

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

The document does not explicitly state the sample size for a "test set" in the context of clinical performance data for the INFINITY EXPLORER. It mentions "Verification and validations tests have been performed," but details about these tests, including sample sizes and data provenance (e.g., country of origin, retrospective/prospective), are not provided in this summary.

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

This information is not provided in the 510(k) summary. The document focuses on technical equivalence and intended use rather than studies requiring expert-established ground truth for a diagnostic AI.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. As no specific clinical test set is detailed, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned for the INFINITY EXPLORER. This device is a display and workstation, not an AI diagnostic tool, so such a study would not be applicable in this context.

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

This is not applicable as the INFINITY EXPLORER is a display and workstation, not an algorithm or AI product requiring standalone performance evaluation in the usual sense. Its performance is tied to its ability to accurately display data from other devices.

7. The Type of Ground Truth Used

Given the nature of the device (a display and workstation for physiological parameters and DICOM images), the concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) does not directly apply. The performance evaluation would likely focus on the accuracy and fidelity of data display and system functionality when compared against the source data (e.g., patient monitor outputs, DICOM image files).

8. The Sample Size for the Training Set

This information is not applicable. The INFINITY EXPLORER is a workstation/display device and does not inherently involve machine learning models that require a "training set."

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

This information is not applicable, as there is no mention of a "training set" for this device.

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