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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The device currently marketed per K001693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and is available for use by medical personnel on patients within a medical facility including adults, children and infants.

The optional AG-920RA module will measure carbon dioxide (CO2), nitrous oxide (N₂O), oxygen (O₂), and any of five anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a bedside monitor.

The device currently marketed per K001693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and alarms within a medical facility. With the new AG-920PA option, the device will measure and display Carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and any of five anesthetic agents (Halothane, Isofilurane, Enflurane, Sevoflurane, and Desflurane).

The provided documentation for the NIHON KOHDEN AMERICA, INC. BSM-4100A Series with AG-920RA Option does not contain the detailed information necessary to complete all sections of the request.

Specifically, the document focuses on regulatory equivalence and general performance testing, not on a specific study designed to prove the device meets acceptance criteria related to accuracy, specificity, or sensitivity of gas measurement.

Here's an attempt to answer based on the available information, with many sections marked as "Not provided in the document."

Acceptance Criteria and Device Performance Study for BSM-4100A Series with AG-920RA Option

Based on the provided 510(k) notification summary (K020046), the acceptance criteria and study details are largely about general performance and safety rather than specific measurement accuracy criteria for the gas analyzer function.

The document states that "The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the device software. The results confirmed that the device performed within specifications." However, it does not specify what those "specifications" or "acceptance criteria" are for the gas measurement accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not provided for the gas analysis function. The document refers to "testing procedures" without specifying sample sizes for specific performance metrics of the AG-920RA module.
• Data Provenance: Not provided. The company is based in Foothill Ranch, California, USA, but actual test location/origin is not specified.
• Retrospective or Prospective: Not provided. The testing described appears to be pre-market validation testing.

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

• Not applicable/Not provided. The testing described focuses on engineering validation and compliance with standards, not on clinical interpretation or expert-derived ground truth for gas analysis.

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

• Not applicable/Not provided. This type of adjudication pertains to human interpretation/review, which is not relevant to the described engineering and performance testing.

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 measurement instrument, not an AI-assisted diagnostic tool requiring human reader studies.

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

• The AG-920RA module, as a measurement device, inherently operates in a "standalone" fashion to measure gas concentrations. The "performance testing procedures" and "software validation" would constitute its standalone evaluation for its specified functions. However, specific results for accuracy, precision, etc., for each gas are not detailed.

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

• For a gas analyzer, the "ground truth" would typically be established by reference instruments or known gas concentrations, calibrated against traceable standards. The document does not specify the exact methods or reference standards used to establish ground truth for the gas measurements. It implies that "performance testing" was conducted which would involve such methods.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. (See #8)

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The INFINITY SC 8000 monitor is intended for multi-parameter patient monitoring. The device will r no INT I 1 1 50 0000 months if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. This device will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.

The INFINITY SC 8000 Monitor is 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 monitor is 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 monitor can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode

With the INFINITY etCO2 + Respiratory Mechanics Pod the monitor can provide spirometric and carbon dioxide monitoring.

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

The SC 8000 Advanced Communication Option II is equivalent to that submitted in K990563 in that it can process and display, from external devices:
MultiGas and MultiGas+ modules (K965062)
Surgical Display Controller (K970348)
Medical Information BUS Protocol Converter (MIB and MIB II) (K970368, K973222, K99166, K003248, and K010640)

A modification has been implemented in the SC 8000 Advanced Communication Option II to accommodate RJ45 connectors for interfacing to the MIB II Protocol Converter (K010640). The MIB II Protocol Converter supports the new IEEE 1073.3.2-2000, Standard for Medical Communications -Transport Profile - irDA Based - Cable Connected.

The provided document is a 510(k) summary for a modification to the Siemens INFINITY SC 8000 monitor, specifically its Advanced Communication Option II to accommodate RJ45 connectors for interfacing with the MIB II Protocol Converter. This submission does not contain details about acceptance criteria, study methodologies, or performance data in the way that would typically be found for a medical device that makes a diagnostic or therapeutic claim based on novel algorithms or complex data analysis.

The device in question, the Siemens Medical Information Bus (MIB II) Protocol Converter (and its integration into the monitor), falls under the classification of a "Monitor, Physiological, Patient (with arrhythmia detection or alarms)" and "Arrhythmia detector & Alarm." The purpose of this 510(k) is to demonstrate substantial equivalence to previously cleared devices for a modification to the communication option, not to prove the primary clinical performance of the physiological monitoring functions themselves.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this document because they are not applicable to the scope of this particular 510(k) submission, which focuses on an interface modification. The primary "study" mentioned is the assessment of "non-clinical performance data for equivalence."

Based on the provided text, here is what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this submission appear to be demonstrating equivalence to previously cleared devices for the communication interface. The relevant standard mentioned is IEEE 1073.3.2-2000.
• Reported Device Performance: No specific clinical performance metrics (e.g., accuracy of arrhythmia detection) are reported for this modification. The document states "Assessment of non-clinical performance data for equivalence" was performed, which implies testing related to the communication functionality (e.g., data integrity, transmission speed, protocol compliance).

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

• Sample Size: Not specified. As this is a modification to a communication interface, it's likely that the "test set" would involve a range of communication scenarios or data types, rather than a patient-based sample size.
• Data Provenance: Not specified.

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/Not specified. This information is typically relevant for studies evaluating diagnostic accuracy or clinical effectiveness, which is not the primary focus of this submission for an interface modification.

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

• Not applicable/Not specified.

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. This type of study is not relevant to a communication interface modification.

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

• Not applicable/Not specified, as the device is a protocol converter and part of a larger monitoring system intended for use by healthcare professionals.

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

• Not applicable/Not specified. The "ground truth" for this modification would likely be compliance with the IEEE 1073.3.2-2000 standard and successful, reliable data transmission and reception from external devices.

8. The sample size for the training set

• Not applicable. This device is not described as involving machine learning or AI models that would require a 'training set.'

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

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document broadly refers to "Assessment of non-clinical performance data for equivalence" (Section J). This indicates that the study focused on demonstrating that the modified communication option maintains the established safety and effectiveness of the predicate devices. The key aspect of this modification is to accommodate RJ45 connectors and support the new IEEE 1073.3.2-2000 standard for medical communications. Therefore, the "study" likely involved:

• Verification of Protocol Compliance: Testing to ensure the MIB II Protocol Converter correctly implements and adheres to the IEEE 1073.3.2-2000 standard.
• Data Integrity Testing: Verification that physiological data transmitted through the new RJ45 interface and protocol converter is accurate, complete, and free from corruption as it passes between the connected external devices and the INFINITY SC 8000 monitor.
• Functional Testing: Ensuring that the monitor can still process and display data from the listed external modules (MultiGas/MultiGas+, Surgical Display Controller, etc.) via the new interface, similar to its predicate.
• Electrical and Mechanical Safety: Given the hardware modification (RJ45 connectors), testing would likely include electrical safety and mechanical compatibility assessments to ensure no new hazards are introduced.

The "acceptance criteria" for this type of submission are typically met by demonstrating that the device modification does not alter the fundamental safety and effectiveness of the predicate device and complies with relevant recognized standards (in this case, IEEE 1073.3.2-2000). The document states "Assessment of non-clinical performance data for equivalence" was done, implying these types of tests were performed to satisfy the FDA's requirements for substantial equivalence for this specific modification. However, no specific results, methods, or details of these non-clinical tests are provided in this summary.

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