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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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