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This device is capable of monitoring:

• Heart Rate .
• Respiration Rate .
• Invasive Pressure .
• Non-Invasive Pressure .
• Arrhythmia .
• Temperature .
• Arterial oxygen saturation ●
• Pulse rate .
• (central) apnea ●
• end-tidal CO2 ●
• ST Segment Analysis .

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 Infinity SC 6002XL / SC 6802XL utilize the oscillometric method to measure noninvasive blood pressure (NIBP). With the release of software version VF2, the NIBP algorithm has changed from a linear to a stepped deflation system.

The SC 6002XL VF2 release includes the support of Masimo sensors in addition to Nellcor sensors already available. Users now have the ability to choose locked options for use of either Nellcor or Masimo sensors.

Customers can now choose either the current 6.5 inch display or a new 8-inch display. The 8inch display has the same configuration and layout as the 6.5-inch display. Current SC 6002XL customers have the ability to upgrade from their present 6.5-inch screen to the new 8-inch display.

To support secure wireless network communication, wireless encryption that complies with 802.11 has been added

This 510(k) submission describes modifications to the Siemens INFINITY SC 6002XL Series. The submission primarily focuses on functional and hardware changes rather than performance changes for existing functionalities, particularly with respect to a medical device's AI component. The NIBP algorithm changed from linear to stepped deflation, but no performance data is provided for this change against acceptance criteria. There's also support for new SpO2 sensors and a larger display option.

Due to the nature of the submission (modifications to an existing device, mainly addressing hardware and software architecture, with no specific AI component mentioned and no performance study explicitly cited for a new AI feature), much of the requested information regarding acceptance criteria and a study to prove device performance is not available in the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating what information is missing:

1. Table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain a table of acceptance criteria or reported device performance for the modifications (NIBP algorithm change, SpO2 sensor support, display size increase, wireless security improvements). This submission focuses on describing the changes and asserting substantial equivalence, rather than providing detailed performance data against specific criteria for new or modified functions.

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

Not provided. The submission states "Assessment of non-clinical performance data for equivalence: Section L" but Section L is not included. It also states "Assessment of clinical performance data for equivalence: Not applicable," which further suggests no specific clinical test set was used for these modifications.

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

Not applicable/Not provided. Given that no clinical performance data is mentioned, there would be no ground truth established by experts for a test set.

4. Adjudication method for the test set

Not applicable/Not provided. As no test set with expert ground truth is mentioned, no adjudication method would have been used.

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 provided text does not describe an AI or an AI-assisted feature. Therefore, no MRMC study or effect size related to AI assistance is mentioned.

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

Not applicable/Not provided. The submission describes modifications to a patient monitor. While it mentions an NIBP algorithm change, it does not describe a standalone performance study for this algorithm as a distinct AI component without human intervention. The "Assessment of non-clinical performance data for equivalence: Section L" might contain related information, but it is not provided.

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

Not applicable/Not provided. As no clinical performance study is described with a test set requiring ground truth, no type of ground truth is mentioned.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a training set, which would typically be associated with machine learning or AI algorithm development.

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

Not applicable/Not provided. Since no training set is mentioned, the method for establishing its ground truth is also not.

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