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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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Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

• . Heart rate
• ECG Arrhythmia Analysis ●
• Arterial oxygen saturation ●
• Pulse rate
• ST segment analysis .

The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.

Siemens' INFINITY MultiView WorkStation Telemetry with TruST enables continuous 12-lead ECG monitoring with a reduced number of electrodes. With TruST only 6 lead wires are required to acquire 12 leads of ECG. TruST relies on conventional lead placement and the INFINITY TruST telemetry transmitters. The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads.

Here's a breakdown of the acceptance criteria and study information for the Siemens Infinity MultiView WorkStation Telemetry System with TruST, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical performance acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds) or precise reported device performance metrics for the TruST feature. Instead, it relies on substantial equivalence to predicate devices and describes the intended functionality. However, we can infer the acceptance criteria are met if the device demonstrates equivalent performance to the predicate devices in terms of its ability to monitor 12-lead ECG with a reduced set of electrodes and reconstruct leads for real-time ST segment assessment.

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

The document does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "Assessment of clinical performance data for equivalence: Section J," implying that clinical data was submitted in that section, but the summary document itself does not contain those details.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with vs. without AI assistance. The focus of this 510(k) is on the device's technical capability to reconstruct leads and monitor ST segments, implying a standalone performance assessment or equivalence claim rather than a human-in-the-loop improvement study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The description of the TruST system, specifically that "The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads" and that "Reconstructed leads are intended for real-time assessment of ST segment changes," strongly suggests that a standalone (algorithm-only) performance assessment would have been done to validate the accuracy of these reconstructed leads against a conventionally acquired 12-lead ECG. However, the summary document does not explicitly describe this study or its results in detail. The focus is on establishing substantial equivalence.

7. Type of Ground Truth Used (Test Set)

The document does not explicitly state the type of ground truth used for the test set. Given the nature of ECG monitoring and ST segment analysis, it's highly probable that the ground truth would have been established by:

• Comparison to conventionally acquired 12-lead ECGs (e.g., a full 12-lead ECG from the same patient at the same time, reviewed by experts).
• Expert consensus based on interpretation of conventional 12-lead ECGs.
• Potentially, correlation with clinical outcomes or pathology if the clinical study was designed to assess diagnostic accuracy for specific conditions (though this is less likely for a 510(k) summary focused on technical equivalence for monitoring).

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not describe how the ground truth for any potential training set was established. Since the TruST system involves "general reconstruction coefficients," it implies a model or algorithm was developed. For such a model, a training set would typically have ground truth established by:

• Conventionally acquired 12-lead ECGs that are considered the gold standard for full 12-lead information.
• Expert cardiologists or electrophysiologists who interpret these full 12-lead ECGs and potentially correlate them with patient data or outcomes to develop the "ground truth" for ST segment morphology and deviation.

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