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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 .

Software version VF5 is the latest release of the Infinity Modular Monitors, including the Infinity Vista XL and Gamma X XL (variants of the SC 7000 and Delta monitors) that supports direct connection to the Scio gas module, display of data received from the Infinity BisX and Infinity Trident NMT pods, as well as other minor software modifications.

The provided text is a 510(k) summary for modifications to Draeger Medical Systems' Infinity Modular Monitors. It states that the device modifications do not alter the fundamental technology and that "Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions". It explicitly states "Assessment of clinical performance data for equivalence: Not applicable".

Therefore, the submission does not contain a study demonstrating the device meets acceptance criteria as typically understood for a new product, but rather asserts equivalence to a previously cleared device for software modifications.

Given this, I cannot extract the requested information as the document explains that no new study demonstrating acceptance criteria was performed. The acceptance criteria and performance are implicitly those of the predicate device (Infinity Modular Monitors, K033694 and Infinity MIB, K033807), as the modifications are deemed not to have changed the fundamental technology or safety/effectiveness.

To directly answer your points based on the provided text:

1. A table of acceptance criteria and the reported device performance
Not applicable. The submission states "Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." This indicates a determination of equivalence rather than performing a new study against specific, newly defined acceptance criteria for the modified device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set is described.

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)
Not applicable. No new ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set adjudication is described.

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. This device is a physiological monitor, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The modifications are to software for a physiological monitor, not a standalone diagnostic algorithm. The phrase "Verification and validation testing performed" refers to internal design control procedures, not necessarily a performance study in the sense of demonstrating a new algorithm's accuracy from scratch.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth is described.

8. The sample size for the training set
Not applicable. No new training set is described for an algorithm in this submission.

9. How the ground truth for the training set was established
Not applicable. No new training set or ground truth establishment is described.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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. 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 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 and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

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 primary modification implemented with the release of software version VF3 is support for the INFINITY Microstream pod, an etCO2 pod that utilizes Oridion's Microstream technology. This technology utilizes a sidestream sampling flowrate appropriate for neonates. The VF3 software release also includes the support of additional pulse oximeter sensors.

The provided document is a 510(k) summary for a medical device (Siemens INFINITY Modular Monitors). It describes modifications to the device and asserts substantial equivalence to a legally marketed predicate device.

It does not contain information on acceptance criteria, a specific study proving the device meets acceptance criteria, or performance metrics typically associated with AI/algorithm-based devices.

The document discusses:

• Device: Siemens INFINITY Modular Monitors (SC 7000 / SC 9000XL / SC 8000)
• Modifications: Support for the INFINITY Microstream pod (etCO2) and additional pulse oximeter sensors with VF3 software release.
• Claim: The modifications have not altered the basic fundamental technology, and testing indicated no new issues relative to safety and efficacy.
• Regulatory Status: Substantial equivalence to predicate devices (K983632, K990563, K003243, K982730, K980882).

Therefore, I cannot provide the requested information as it is not present in the given text.

The prompt asks for details about an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device. The provided FDA 510(k) summary is for hardware and software updates to a patient vital signs monitor, not an AI/algorithm device. The assessment mentioned ("Assessment of non-clinical performance data for equivalence: See Section J") would refer to traditional medical device testing (e.g., electrical safety, EMC, functional verification) to ensure the updated device performs as intended and is safe, similar to the predicate device. It does not involve the types of studies or performance metrics relevant to AI models, such as sensitivity, specificity, F1-score, AUC, etc., which would be compared against a ground truth established by experts.

To reiterate, the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, training set ground truth establishment) is not found in the provided 510(k) summary because it describes a different type of medical device submission than one for an AI/ML algorithm.

Ask a specific question about this device

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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Ask a specific question about this device

The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring:

• Heart rate .
• Respiration rate .
• Invasive pressure .
• Non-invasive pressure .
• Arrhythmia ●
• . Temperature
• Cardiac output .
• Arterial oxygen saturation .
• Pulse rate .
• End-tidal carbon dioxide .
• (central) apnea
• ST Segment Analysis .
• 12-Lead ST Segment Analysis .
• Transcutaneous Oxygen and Transcutaneous Carbon Dioxide (tpO2/CO2) .

With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are capable of measuring:

• Respiration rate
• Inspired and expired Carbon Dioxide (CO2) .
• Inspired and expired Oxygen (MultiGas+TM only) .
• Average inspired Oxygen (MultiGas™ only) .
• Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, . and Nitrous Oxide.

The SC 7000 and SC 9000XL can interface with third party devices.

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 and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and Transcutaneous Oxygen which is intended for use in the neonatal population when the patient is not under gas anesthesia.

The SC 7000 and SC 9000XL modular bedside monitors are enhanced versions of the SC 9000 (predicate device - original submission K946306) and use the same front panel display and user interface as the SC 9000. In addition, the SC 9000 docking station is compatible with the SC 7000 and SC 9000XL for power and communication capabilities.

The SC 7000 (mid-level monitor) and the SC 9000XL (high-end monitor) are additions to the Siemens INFINITY Modular Portable Bedside Monitoring Series. Both the SC7000 and SC 9000 XL utilize the same electronics and software, but with different base configurations and available options.

The provided text describes the Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors and their intended use, but it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary, which is typically a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. While it lists various monitoring capabilities and specifications, it does not detail performance metrics, study designs, or results that would demonstrate the device meets specific acceptance criteria.

Therefore, many of the requested sections about acceptance criteria and study details cannot be answered from the provided text.

Here's what can be extracted based on the information given, with explicit notes where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document lists the types of parameters the monitors are capable of measuring (e.g., heart rate, respiration rate, invasive pressure, etc.), but it does not specify performance metrics (e.g., accuracy, precision, response time, false alarm rates) or compare them against predefined acceptance criteria.

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

Not provided. The document does not describe any specific test set or clinical study data.

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

Not provided. The document does not describe any test set or ground truth establishment process.

4. Adjudication Method for the Test Set

Not provided. The document does not describe any test set or adjudication process.

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 document describes a medical device (patient monitor), not an AI algorithm for diagnostic imaging or interpretation by human readers. Therefore, an MRMC study or AI assistance is not relevant to the information provided.

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

Not applicable. The device is a patient monitor, which by its nature is an "algorithm only" type of device in terms of measuring and displaying parameters. However, the document does not contain details of standalone performance studies for its various algorithms (e.g., arrhythmia detection, ST segment analysis). It relies on substantial equivalence to a predicate device.

7. The Type of Ground Truth Used

Not provided. As no specific performance studies are detailed, the type of ground truth is not mentioned.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is a hardware and software system for patient monitoring, not a machine learning model that undergoes "training" in the conventional sense for AI. If there were internal algorithm development or validation, the sample sizes for such activities are not mentioned.

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

Not applicable/Not provided (see #8).

Summary of Device and Regulatory Status:

• Device Name: Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors
• Predicate Device: Siemens SC9000/SC9015 Patient Monitoring System (K946306)
• Regulatory Pathway: 510(k) premarket notification to establish substantial equivalence.
• Date of Submission: August 13, 1998
• FDA Clearance Date: August 24, 1998
• Intended Use: To monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, cardiac output, central apnea, end-tidal carbon dioxide, ST segment analysis, 12-Lead ST Segment Analysis, and transcutaneous oxygen & transcutaneous carbon dioxide. Also includes measurement of various gas concentrations with add-on modules. The device provides visual and audible alarms.
• Intended Population: Adult, Pediatric, and Neonatal (with specific parameter restrictions for different populations).
• Intended Environment: Healthcare environment where patient care is provided by healthcare professionals.
• Evidence for Equivalence: The document indicates an "Assessment of non-clinical performance data for equivalence: See Section U" and "Assessment of clinical performance data for equivalence: See Section V". However, these sections are not provided in the given text, so the specific details of the data reviewed by the FDA for substantial equivalence are missing. The primary argument in the provided text for equivalence is the similarity in manufacturer, intended use, population, environment, display, waveforms, arrhythmia detection, modularity, networking, NBP, MIB, MultiGas, ST, and IBP features to the predicate device.

Ask a specific question about this device

The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring:

• Heart rate
• Respiration rate
• Invasive pressure
• Non-invasive pressure
• Arrhythmia
• Temperature
• Cardiac output
• Arterial oxygen saturation
• Pulse rate
• End-tidal carbon dioxide
• (central) apnea
• ST segment analysis

With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are capable of measuring:

• Respiration rate
• Inspired and expired Carbon Dioxide (CO2)
• Inspired and expired Oxygen (MultiGas+TM only)
• Average inspired Oxygen (MultiGas™ only)
• Inspired and expired gas concentrations of Enflurane, Isoflurane, Desflurane, Desflurane, Sevollurane, and Nitrous Oxide.

The SC 7000 and SC 9000XL can interface with third party devices.

The devices are intended to be used in the environment where patient care is provided by Healtheare. 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 and ST Segment Analysis which are intended for use in the adult and pediatric populations only; and Arrhythmia which is intended for use in the adult population only.

The SC 7000 and SC 9000XL modular bedside monitors are enhanced versions of the SC 9000 (predicate device - original submission K946306) and use the same front panel display and user interface as the SC 9000. In addition, the SC 9000 docking station is compatible with the SC 7000 and SC 9000XL for power and communication capabilities.

The SC 7000 (mid-level monitor) and the SC 9000XL (high-end monitor) are additions to the Siemens INFINITY Modular Portable Bedside Monitoring Series. Both the SC7000 and SC 9000 XL utilize the same electronics and software, but with different base configurations and available options.

I am sorry, but the provided text does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance for the Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors.

The document is a 510(k) notification and summary, which primarily establishes substantial equivalence to a predicate device (Siemens SC9000). It focuses on:

• Device Description: Explains that the SC7000 and SC9000XL are enhanced versions of the SC9000 and share electronics/software.
• Intended Use: Lists the physiological parameters the devices are intended to measure and alarm functions.
• Predicate Device Identification: Specifies the Siemens SC9000 as the predicate.
• Table of Device Similarities and Differences: Compares the new devices to the predicate in terms of manufacturer, intended use, population, environment, display, waveforms, and various measurement capabilities, noting mostly "Same."
• Assessment of non-clinical and clinical performance data for equivalence: The document refers to Sections U and V for this assessment but does not include the content of these sections.
• FDA Letter: Confirms substantial equivalence but does not detail performance studies.
• Indications for Use: Reiterates the parameters monitored and populations.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This level of detail regarding specific performance metrics and their acceptance thresholds, along with the device's actual measured performance, is not present.
2. Sample sizes used for the test set and the data provenance: No information on test set sample sizes or data origin is provided.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No mention of experts or ground truth establishment for a test set.
4. Adjudication method for the test set: Not discussed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No mention of such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not discussed, as this device does not appear to be an AI/algorithm-only device in the context usually implied by this question. It's a physiological monitor.
7. The type of ground truth used: Not specified.
8. The sample size for the training set: Not applicable for a traditional physiological monitor without AI/machine learning training sets in the modern sense.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on establishing substantial equivalence to a legally marketed predicate device, which is a different regulatory pathway than providing detailed performance studies for novel AI/algorithm-driven devices with specific acceptance criteria. For physiological monitors like these, compliance is typically demonstrated through engineering testing, adherence to recognized standards, and comparison of specifications to the predicate device, rather than the types of clinical studies you've outlined for AI.

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