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Infinity Explorer software enables the Patient Vicinity Workstation (PVW) to function as the secondary display for physiological parameters received from the primary Infinity modular monitors. Infinity Explorer displays only visual parameter alarm data for the connected modular monitor and does not generate audible alarms. Audible and visual alarms are available at the primary Infinity modular monitors.

The device is intended to be used in an environment where patient care is provided by healthcare professionals such as 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 adult, pediatric, and neonatal populations.

The Infinity Explorer software runs on a specialized medical grade Patient Vicinity Workstation (PVW) and allows the user to extend the viewing capability of the bedside monitor and integrate additional patient information originating from various sources throughout the hospital on a single display. Additional patient information can reside remotely on a clinical information system, HIS, Web, Lab Department, etc.

Specifically, the Infinity Explorer software extends the real-time viewing capabilities of the primary patient monitors that are part of the Infinity modular monitoring series. Infinity Explorer software runs on a dedicated Infinity C700 for IT patient vicinity workstation. The workstation monitors are touch screen computer workstations that allow you to interact with menu functions. However, a keyboard and mouse may also be used to interact with the display. The patient connected bedside monitor is the primary monitoring device and the workstation monitor with Infinity Explorer software is the secondary display monitor. All data to and from the bedside patient monitor is transmitted to or received from Infinity Explorer software over the Infinity Network. Infinity Explorer software can also provide control back to the connected bedside patient monitor. There are no audible alarms on the patient vicinity workstation running Infinity Explorer software. However, there are visual alarms initiated at the primary monitor that present on the workstation display running Infinity Explorer software.

The provided text describes the regulatory clearance for the "Infinity Explorer" software, which functions as a secondary display for physiological parameters from primary Infinity modular monitors. The document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific performance acceptance criteria in terms of clinical accuracy or diagnostic efficacy.

Therefore, many of the requested elements regarding acceptance criteria for device performance, sample sizes for test sets, expert involvement, and ground truth establishment are not present in this regulatory document. The performance data section primarily addresses safety, compatibility, and software verification/validation, rather than clinical efficacy.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not detail specific sample sizes for test sets in the context of clinical performance or accuracy. The "test sets" referenced are related to engineering and software validation (e.g., electrical safety, EMC, mechanical, software verification).
• Data provenance (country of origin, retrospective/prospective) is not applicable or specified for the types of testing described.

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

• Not applicable. The document describes engineering and software validation tests, not clinical performance studies requiring expert ground truth establishment.

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

• Not applicable. This is not a clinical study involving adjudication of results.

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 MRMC comparative effectiveness study was done. This device is a display software for physiological parameters, not an AI-assisted diagnostic tool.

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

• The document implies standalone performance for the software's functionality and displays visual alarm data independently, but this is assessed through software verification and validation, not as a standalone clinical diagnostic algorithm. It functions as a "secondary display" to a human-monitored primary device.

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

• For the software verification and validation, the "ground truth" would be the expected functional behavior and output as defined by the software requirements and design specifications, and the established standards (e.g., IEC 60601-1-8 for alarms). It does not involve clinical ground truth from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that would typically involve a "training set" for model development. The verification and validation applies to the pre-programmed software.

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

• Not applicable, as there is no training set mentioned for this type of software device.

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This device is capable of displaying physiological parameters received from Infinity Modular monitors 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 an 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 Infinity Explorer is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors and integrate additional patient information on a single display. Infinity Explorer is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. This Special submission includes minor modifications to the hardware and software.

The provided text describes a 510(k) summary for the Draeger Medical Systems, Inc. Infinity Explorer, a critical care workstation. However, it does not include detailed information regarding specific acceptance criteria, a standalone study proving device performance against those criteria, or an MRMC comparative effectiveness study with AI.

Here's the information that can be extracted and a clear statement of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide a table with specific, quantifiable acceptance criteria (e.g., accuracy, reliability, latency) and corresponding reported performance metrics for the device. The statements are general and qualitative about overall performance and equivalence to previous versions.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not applicable as the document does not mention a "test set" in the context of expert review for ground truth establishment. The testing described is for "overall performance" and "verification and validation" of the device's functionality and safety, not for diagnostic accuracy evaluated against expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable for the same reason as above.

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

• No MRMC comparative effectiveness study is mentioned. This device is a critical care workstation for displaying physiological parameters and DICOM images, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study with AI assistance is not relevant to the described device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• The document states: "Testing has been performed to verify the overall performance of the INFINITY Explorer with VF6 modifications and the new MDS III." and "Verification and validation testing performed indicate that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)."
• This suggests standalone testing of the device's functionality and performance as an integrated system, but it's not a "standalone (algorithm only)" study in the context of AI diagnostic algorithms. It's a system performance validation.

7. The Type of Ground Truth Used

• Not applicable in the context of diagnostic accuracy for this device. The "ground truth" for the verification and validation testing would be the expected functional behavior and safety requirements of the device's components and system as designed.

8. The Sample Size for the Training Set

• Not applicable. This device is a critical care workstation, not a machine learning model that requires a training set.

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

• Not applicable for the same reason as above.

Summary of Missing Information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and verifying that modifications do not alter the fundamental technology or safety. It lacks specific details regarding quantitative acceptance criteria, explicit performance metrics against those criteria, or any studies involving expert review for diagnostic accuracy or AI performance. The nature of the device (a critical care workstation) explains why many of these specific AI-centric questions are not applicable to the content provided.

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This device is capable of displaying physiological parameters received from INFINITY Modular monitors 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 an 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 software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. The VF4 modifications include:

• New MDSII Hardware
• New user interface with enhanced monitor applications

The provided text is a 510(k) summary for the INFINITY Explorer with VF4 and MDS II. It describes a software-driven application that extends the viewing capability of physiological monitors. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, a common component of performance testing for AI/ML-enabled devices. The submission is for a device modification of an existing product, and focuses on general device functionality, safety, and regulatory compliance rather than performance metrics of the device as related to a specific diagnostic or prognostic task.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance (algorithm only) study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

What is present in the document is a statement regarding non-clinical performance data:

"Assessment of non-clinical performance data for equivalence: Testing in accordance with internal design control procedures indicates no new issues relative to safety and efficacy for INFINITY EXPLORER with software version VF4 and the new MDS II."

This statement indicates that internal testing was conducted, but it does not provide specific acceptance criteria, study details, or performance metrics. It also explicitly states "Assessment of clinical performance data for equivalence: Not applicable," implying that no standalone clinical performance study was deemed necessary for this specific device modification under the 510(k) pathway.

This type of submission is common for minor modifications to existing medical devices where the primary focus is to ensure that the changes do not introduce new safety or efficacy concerns, rather than to establish or re-establish performance against specific clinical endpoints.

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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 an 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 software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors (SC 7000, 8000 9000XL) and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. In the initial release of the Infinity EXPLORER, the software was run on Siemens' own dedicated Medside Data Station (MDS), a patient vicinity computer based on Low Power Intel Pentium-III embedded processor.

The subject of this submission is a modification implemented that enables the INFINITY EXPLORER to run on a commercially available patient vicinity computer. With the release of software version VF2.1 the INFINITY EXPLORER has been tested for use with the Medside Data Station II (MDS II).

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the Siemens INFINITY Explorer, which describes a software modification to run on a commercially available patient vicinity computer.

The summary focuses on:

• Device Identification and Description: Detailing the INFINITY Explorer, its purpose, and the modification being submitted (enabling it to run on the Medside Data Station II).
• Intended Use: What the device is designed to do (display physiological parameters, alarm data, and DICOM images).
• Regulatory Information: Classification, predicate device, and contact details.
• FDA Correspondence: A letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device.

Specifically, the document states:

• "Assessment of non-clinical performance data for equivalence: Section J" - This indicates that non-clinical performance data was assessed for equivalence, but details of the acceptance criteria, the study performed, or its results are not included in this summary. "Section J" likely refers to a section within the full 510(k) submission, which is not provided here.
• "Assessment of clinical performance data for equivalence: Not applicable" - This directly states that clinical performance data was not applicable for this submission, meaning no clinical study was performed for this specific modification to prove performance.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text. The document focuses on regulatory equivalence for a software modification, not a performance study against predefined criteria.

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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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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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