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.

Device Description

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.

AI/ML Overview

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.

Summary

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JUL 2 7 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Siemens Medical Corporation Ms. Malgorzata Stanek, RAC Senior Technical Specialist 186 Wood Avenue South Iselin, NJ 08830

Re: K994231

Trade/Device Name: Siemens Integrated Operating System (SIOS) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA Dated (Date on orig SE ltr): May 30, 2000 Received (Date on orig SE Itr): May 31, 2000

Dear Ms. Stanek,

This letter corrects our substantially equivalent letter of August 10, 2000.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 -

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 8

INDỊCATIONS FOR USE

510(k) Number (if known):	K99423.1
Device Name:	Siemens Integrated Operating System (SIOS)

Indications For Use:

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.

(Please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

ﯾﺎﮞ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ During

(Division Sign-Off) Division of General Restorative Devices Division or Ser K99423

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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K994231

ATTACHMENT 7

510(K) SUMMARY

FOR THE

SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)

Submitted by:

Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

December 15, 1999

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Contact Person:

Ms. Malgorzata Stanek Phone: (732) 321-3950 Fax: (732) 321-4841

2. Device Name and Classification:

Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

Siemens Integrated Operating System (SIOS) Endoscope and/or Accessories General Surgery 21 CFR § 876.1500 Class II 78KOG

3. Substantial Equivalence:

The Siemens Integrated Operating System is designed to control select medical equipment in the operating room (OR), allow trained medical personnel direct control of the equipment using remote control (i.e., verbal commands, hand input device), and network with hospital information systems (HIS) and picture archival communication systems (PACS).

The package is substantially equivalent to the following devices:

Device Name	Manufacturer	FDA 510(k) Number	FDA Clearance Date
HERMESTM Operating RoomControl Center and Accessories	Computer Motion	K980787	7/31/98
EndoALPHATM IntegratedEndosurgery System	Olympus	K981993	8/21/98

510(k) for Siemens Integrated Operating System (SIOS) Siemens Medical Systems, Inc.

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4. Device Description:

પં Intended Use of the Device:

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

Summary of Technological Characteristics of the Devices Compared to the ર. Predicate:

The SIOS product is substantially equivalent to HERMES TM by Computer Motion and EndoALPHA ™ by OLYMPUS. All systems enable remote control of connected devices without changing the original functionality of those devices.

K994231

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.