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The SIOS product is intended to optimize procedures in the operating room by providing consistent preoperative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities.

The SIOS product is limited to use with the following products:

• (1) Wolf Endocam 3CCD Endocam 5507,
• (2) Wolf Light Source Auto-CP 5131,
• (3) Wolf Insufflator Laparo CO2 Pacu 2332, and
• (4) Maquet OR Table ALPHAMAQUET 1150.

The Siemens Integrated Operating System (SIOS) is a system capable of networking select medical and non-medical equipment in the operating room (OR) and allowing trained medical personnel direct control of the equipment using remote control (i.e. voice command, touch screen console). The device combines a number of individual functional units through a standard interface to a centralized computer control station.

The provided text is a 510(k) summary for the Siemens Integrated Operating System (SIOS), which is an older document (dated December 15, 1999, with a corrected letter on July 27, 2015). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with acceptance criteria as would be expected for a novel AI/ML-driven device today.

Therefore, the document does not contain the detailed information required to populate a table of acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment methods, or information about expert adjudication, MRMC studies, or standalone performance. The SIOS is described as a system for controlling existing medical and non-medical equipment in an operating room and networking capabilities, not a diagnostic or AI-driven interpretative device that would typically undergo such performance evaluations.

Here’s a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) for the SIOS. Its purpose is to control other devices and handle data.

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

• Cannot be provided. The document does not describe any specific test set or data used for performance evaluation in the context of a clinical study or diagnostic accuracy assessment. The submission focuses on the functionality and safety of the control system itself.

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)

• Cannot be provided. Since no specific test set requiring expert ground truth is mentioned, this information is not available.

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

• Cannot be provided. This information is not relevant or present in the document given the nature of the device and the 510(k) submission type.

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

• Cannot be provided. An MRMC study is not mentioned. The SIOS is an integrated operating system for control and data handling, not a device that assists human readers in interpreting medical images or data.

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

• Cannot be provided. The SIOS is a system for controlling other devices; it doesn't have an "algorithm-only" performance that would be evaluated in this context. Its function is to facilitate human operators' control of other equipment.

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

• Cannot be provided. No ground truth is established as the device is not making diagnostic or interpretative claims.

8. The sample size for the training set

• Cannot be provided. Training sets are typically associated with machine learning or AI models, which are not described for the SIOS in this document.

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

• Cannot be provided. As no training set is mentioned, this is not applicable.

Summary from the provided document:

The Siemens Integrated Operating System (SIOS) is a control and networking system for operating rooms. The 510(k) submission (K994231) demonstrates its substantial equivalence to predicate devices (HERMES™ Operating Room Control Center and Accessories by Computer Motion, and EndoALPHA™ Integrated Endosurgery System by Olympus). The "study" referenced in this context is the general comparison to these predicate devices, focusing on the technological characteristics and intended use rather than
quantitative performance metrics of a diagnostic or AI algorithm. The core functionality and safety were deemed equivalent by the FDA based on the comparison of features and intended use.

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