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This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to Siemens R50 recorders, either directly or via the INFINITY network.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, e.g., Physicians, Nurses, and technicians, trained on the use of the devices, who will make the final assessment of the patient's medical condition.

Device Description

SC 6002XL Wireless Option

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 MultiView WorkStation supports wireless operation by providing information to the SC6002XL allowing the monitor to have a unique network address. Once the SC6002XL has established itself on the network, the MultiView WorkStation has no new functionality. MultiView WorkStation hazards identified with the MVWS support of the wireless functionality have been addressed in MVWS VF2 software.

SC 6002XL with Full Arrhythmia Option

The SC 6002XL VF1 release includes the Full Arrhythmia Option. With this option eight additional arrhythmia calls are enabled. The arrhythmia algorithm is the same algorithm found in Siemens MVWS INFINITY Telemetry (K003179), as well as Siemens patient monitors, including: SC 7000 / SC 9000XL (K980882) and SC 8000 (K983632). Previous releases of the SC 6002XL (K993974 DC 900012 (1196002) the same arrhythmia algorithm, however, in the first two releases of the SC and I would the Basic Arrhythmia functionality, with fewer arrhythmia calls was made available.

Fourth Channel Option

In addition, to provide customers with more readily available information, a fourth channel is being made available. The fourth channel is also a locked option.

AI/ML Overview

The provided document is a 510(k) summary for the Siemens INFINITY SC 6002XL Modifications. It details the device, its intended use, and indicates the basis for its substantial equivalence determination to previously marketed predicate devices. However, it does not include detailed information about specific acceptance criteria, a study proving performance against those criteria, or the methodology (like ground truth establishment, sample sizes for training/testing, or expert qualifications) that would typically be found in a clinical or performance study report.

Here's a breakdown of the information that can be extracted and, crucially, what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the given document. The document states "Assessment of non-clinical performance data for equivalence: Section L" but does not elaborate on the specific criteria or the results of this assessment. For clinical performance, it explicitly states "Assessment of clinical performance data for equivalence: Not applicable."

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

This information is not provided. Since no clinical performance study is described, there's no mention of a test set, its sample size, or data provenance.

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

This information is not provided. As no clinical performance study is described with a test set, there is no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set:

This information is not provided. Since no test set is described, there is no adjudication method mentioned.

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:

This information is not provided. The document makes no mention of an MRMC study or any AI assistance. The device is a physiological monitor, not an AI-driven image interpretation or diagnostic aid that would typically involve human readers.

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

This information is not explicitly stated as a standalone performance study in the document. The document refers to the arrhythmia algorithm being "the same algorithm found in Siemens MVWS INFINITY Telemetry (K003179), as well as Siemens patient monitors, including: SC 7000 / SC 9000XL (K980882) and SC 8000 (K983632)." This implies that the algorithm's performance was evaluated in the context of those previous submissions, but documentation for that specific evaluation is not part of this 510(k) summary.

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

This information is not provided for any specific study in this document.

8. The sample size for the training set:

This information is not provided. The document does not describe a training set as it pertains to an AI/ML algorithm being developed or refined.

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

This information is not provided.

Summary of what the document does provide regarding the device's basis for market clearance:

The document focuses on demonstrating substantial equivalence to previously cleared devices (predicates) rather than providing a detailed de novo clinical performance study report.

Predicate Device: Siemens INFINITY SC 6002XL (K993974, K002105) and the arrhythmia algorithm from Siemens MVWS INFINITY Telemetry (K003179) and other Siemens patient monitors (SC 7000/SC 9000XL K980882, SC 8000 K983632).
Modifications: The 510(k) submission addresses modifications to the existing INFINITY SC 6002XL, specifically:
- Wireless Option: Adding a wireless ethernet adapter for network connectivity. The functionality is stated to be "the same functionality as a hardwired system."
- Full Arrhythmia Option: Enabling eight additional arrhythmia calls using an existing, previously cleared arrhythmia algorithm found in other Siemens devices.
- Fourth Channel Option: Providing a fourth channel of information.
Assessment of Equivalence:
- Non-clinical performance data: Referenced as "Section L," but details are not provided in this summary.
- Clinical performance data: Stated as "Not applicable," indicating that for these specific modifications, new clinical data was not deemed necessary by the submitter to demonstrate substantial equivalence, likely due to the use of a previously cleared algorithm and the nature of the wireless and fourth-channel additions.
Standards: IEEE 802.11 Standard for Wireless Medium Access Method (MAC) and Physical Layer (PHY) is listed, suggesting that the wireless component's performance would be evaluated against this standard.

In essence, the document asserts that the modified device is substantially equivalent to existing, legally marketed devices based on the inclusion of proven components (like the arrhythmia algorithm) and standard compliant technologies (like wireless networking), without presenting new, detailed performance study outcomes for these specific modifications.

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