The ConnectedOR Hub is indicated for use with compatible endoscopic and general surgery devices. The ConnectedOR Hub can be used in general laparoscopy, nasopharyngoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectory, laparoscopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. ConnectedOR Hub users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

Device Description

The Connected OR Hub with Device and Voice Control is a medical device that allows the surgeon to control the state, selection, and settings of any compatible device attached to it. It also has operating room documentation functionalities (Class I device function) to electronically capture, transfer, store and display medical device data independently of the functions or parameters of the connected medical device. The Connected OR Hub with Device and Voice Control consists of the following: a. A Connected OR Hub console b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control) c. A Voice control package (contains an optional software upgrade and a headset and base station)

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ConnectedOR Hub with Device and Voice Control." This submission seeks to demonstrate substantial equivalence to a predicate device and does not involve clinical studies to establish new device performance. Therefore, the information typically requested regarding acceptance criteria and a study proving a device meets them for a novel medical AI/ML device is not directly applicable in this context.

However, based on the non-clinical testing summary, we can infer some "acceptance criteria" through the tests performed to show equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Test Method)	Reported Device Performance
Device and Voice Control Performance: Performance of device and voice control functionalities with compatible devices in accordance with device performance specifications.	Pass
Compatibility with Connected OR Spoke: Compatibility with Connected OR Spoke in accordance with device performance specification.	Pass
Environmental Performance: Functionality validated for specified operating temperature and humidity range.	Pass
Video Compatibility: Compatibility with supported Cameras, Monitors, and peripherals.	Pass
Memory Profiling and Performance: Performance and system response times of Class II Medical Device functionality (Voice and Device Control functionality) while Class I documentation functionalities are in use, in accordance with device performance specifications.	Pass
Voice Recognition Performance: Voice recognition performance of the proposed system when voice commands are issued to the system in accordance with device performance specification.	Pass
Voice Accuracy Benchmark: Voice recognition accuracy of the proposed system when voice commands are issued is equivalent to or better than the predicate system.	Pass
Wireless Technology Performance: Performance and coexistence of wireless technology in accordance with AAMI TIR 69:2017, ANSI C63.27:2017, and FDA guidance.	Pass
Electrical Safety: In accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).	Pass
EMC Testing: In accordance with IEC60601-1-2 Edition 4.0 2014-02.	Pass
Usability: Designed and tested per IEC 60601-1-6 Edition 3.1 2013-10 and ANSI/AAMI/IEC 62366-1:2015.	Pass
System Validation and Simulated User Testing: Validated system performance in accordance with defined user needs and device performance specifications.	Pass
Software Validation & Verification: In accordance with IEC 62304 and FDA Guidance Document Principles of Software Validation.	Pass
Cybersecurity Verification and Network scan: In accordance with device performance specifications, cybersecurity risk assessment and FDA guidance documents.	Pass

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described focuses on engineering, performance, and regulatory compliance.
The "Voice Accuracy Benchmark" test compares the proposed system's voice recognition accuracy to the predicate system's accuracy. While it implies a test set of voice commands, the size and provenance (e.g., country of origin, retrospective/prospective) of this specific test set are not provided. Given it's a benchmark against an existing system, the data would likely be internally generated for verification purposes rather than external clinical data.

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):

The document does not describe the establishment of ground truth by external experts for a clinical "test set." The "ground truth" for the engineering performance tests would be defined by the technical specifications of the device itself and established industry standards.
For the "Voice Accuracy Benchmark," the "ground truth" for each voice command would be the intended action if the command was correctly recognized. The process of establishing this ground truth (e.g., human transcription of voice commands, predefined correct responses) and the involvement of experts are not described.

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

No explicit adjudication method is described, as the testing is primarily technical performance verification, not an interpretation of medical images or clinical outcomes requiring expert consensus.

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, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "The Connected OR Hub with Device and Voice Control does not require clinical studies to support the determination of substantial equivalence." This is a device for surgical control and documentation, not an AI diagnostic aid for human readers.

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

The device's core functions (device and voice control, documentation) inherently involve "human-in-the-loop." The voice control relies on a human speaking commands, and device control involves a human using an IR remote. While the voice recognition algorithm itself performs "standalone" within its module, its performance is measured in how effectively it responds to human input. The "Voice Accuracy Benchmark" test can be considered a standalone performance assessment of the voice recognition algorithm.

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

For technical performance tests, the "ground truth" is defined by the device's technical specifications and relevant industry standards (e.g., for electrical safety, EMC, software validation).
For the "Voice Accuracy Benchmark," the ground truth for individual voice commands would be the correct interpretation or expected device action based on the command. The specific method for establishing this correct interpretation is not detailed. It is highly likely based on predefined command sets and expected responses.

8. The sample size for the training set:

The document does not refer to a "training set" in the context of machine learning. The device utilizes a voice recognition software engine, which would have been trained. However, the details of this training (e.g., sample size of voice data, types of voices) are not provided in this regulatory submission, as the focus is on the equivalence of the current device's voice recognition performance to a predicate.

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

As no training set details are provided, the method for establishing its ground truth is also not described. For a voice recognition system, this would typically involve large datasets of spoken words or phrases, meticulously transcribed or annotated to serve as the ground truth for the machine learning model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

November 5, 2018

Stryker Jay Nayar Staff Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

Re: K181258

Trade/Device Name: ConnectedOR Hub with Device and Voice Control Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, HRX Dated: September 26, 2018 Received: September 28, 2018

Dear Jay Nayar:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/7 description: The image shows a digital signature. The signature is from Long H. Chen -S. The date of the signature is 2018.11.05, and the time is 14:30:52 -05'00'.

Date: 2018.11.05

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181258

Device Name

ConnectedOR Hub with Device and Voice Control

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is written in all lowercase letters.

Section 5. 510(k) Summary

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

General Information:

510(k) Sponsor:	Stryker Endoscopy
Address	5900 Optical CourtSan Jose, CA 95138
FDA Registration Number	2936485
Contact Information	April MalmborgDirector, Regulatory AffairsPhone: 408-754-2473Email: april.malmborg@stryker.com
Date Prepared	11/02/2018

Device Identification:

Proposed Device:

Trade Name	Connected OR Hub with Device and Voice Control
Common Name	SDC 4K Information Management System
Regulatory Class	II
Classification Name	Laparoscope, General and Plastic Surgery
Regulation Number	21 CFR 876.1500
Product Code	GCJ
Subsequent Product Code	HRX

Predicate Device:

Trade Name	Stryker SDC3 HD Information Management System withWireless Device Control Capability
Common Name	SDC3 HD Information Management System
Regulatory Class	II
Classification Name	Laparoscope, General and Plastic Surgery
Regulation Number	21 CFR 876.1500
Product Code	GCJ
Subsequent Product Code	HRX
This device has not been subjected to a design-related recall

{4}------------------------------------------------

Device Description:

The Connected OR Hub with Device and Voice Control (also referred to as proposed device in the following sections) consists of the following:

a. A Connected OR Hub console
b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control)
c. A Voice control package (contains an optional software upgrade and a headset and base station)

The proposed device is the latest iteration of the Stryker SDC3 HD Information Management System with wireless device control (hereafter referred to as "predicate device", cleared under K160332). The device and voice control features of the proposed device are identical to the predicate device. The operating room documentation functionalities of electronically capturing, transferring, storing and displaying medical device data (Class I device functions) independently of the functions or parameters of any connected medical device remain similar to the predicate device. The proposed device accesses existing controls within each device and is secondary to the built-in control interface that is already on each device which is identical to the predicate device

Although the device and voice control characteristics of the proposed device remain the same as compared to the predicate device, the operating system and the hardware were altered significantly leading to the need for a traditional submission per the FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a 510(k) for a Software Change to an Existing Device. This submission hence focuses on providing data regarding substantial equivalence of the proposed device (Stryker Connected OR Hub with Device and Voice Control) to the predicate device (Stryker SDC3 HD Information Management System with wireless device and voice control)

Indications for Use:

This submission is not proposing any changes from the indications cleared for the predicate device.

The Connected OR Hub is indicated for use with compatible endoscopic and general surgery devices. The Connected OR Hub can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic

{5}------------------------------------------------

lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. Connected OR Hub users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

Intended Use:

This submission is not proposing any changes from the intended uses cleared for the predicate device.

The intended use of the Connected OR Hub with Device and Voice Control system is to allow for voice control and remote control of medical device settings by the surgeons or operating room personnel, thereby eliminating the need of manual operation of those devices compatible with the Connected OR Hub, or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment. It also has an additional digital documentation functionality to electronically capture, transfer, store and display medical device data (Class I device function), which is independent of the functions or parameters of any attached device.

Comparison of Technological Characteristics with the Predicate Device:

The Connected OR Hub with Device and Voice Control has the same technological characteristics and design as the predicate with the exception of the software operating system and internal hardware components. The software and hardware were upgraded to support product sustainment, higher processing speeds and higher video resolution. All other technological characteristics of the proposed device are the predicate. The proposed device uses the same device control communication protocols as the predicate device, employs the same voice recognition software engine and controls the same types of connected devices as the predicate device. The Connected OR Hub has similar technological characteristics as the predicate device in the following areas:

Operating principles ●
Software architecture ●
Electrical characteristics
Mechanical characteristics
Communication characteristics
Performance characteristics ●
. Compatibility with controllable devices as listed in the product labeling
Energy source
Materials (no patient contacting materials) ●

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is the logo for Stryker Corporation, a medical technology company.

A complete comparison of technological characteristics between the proposed and predicate devices is provided in Section 14- Substantial Equivalence Discussion.

Summary of Non-Clinical Testing Performed:

Test	Method	Results
Device andVoice Controlperformance	Verified if the performance of device and voice controlfunctionalities with compatible devices is in accordance withdevice performance specifications.	Pass
Compatibilitywith ConnectedOR Spoke	Verified if proposed device was compatible with ConnectedOR Spoke in accordance with device performancespecification.	Pass
Environmentalperformance	The functionality of the product was verified for the specifiedoperating temperature and humidity range.	Pass
VideoCompatibility	Verified if the Connected OR Hub is compatible withsupported Cameras, Monitors, and peripherals that the Strykercustomers use in the field.	Pass
MemoryProfiling andPerformance	Verified if the performance and system response times of theClass II Medical Device functionality (Voice and DeviceControl functionality) while the Connected OR Hub's Class Idocumentation functionalities is in use are in accordance withdevice performance specifications.	Pass
VoiceRecognitionPerformance	Verified if the voice recognition performance of the proposedsystem when voice commands are issued to the system inaccordance with device performance specification.	Pass
Voice AccuracyBenchmark	Verified if the voice recognition accuracy of the proposedsystem when voice commands are issued to the proposedsystem are equivalent or better to the predicate system.	Pass
Wirelesstechnologyperformance	Verified the performance and coexistence of the wirelesstechnology in the proposed device in accordance with AAMITIR 69:2017, ANSI C63.27:2017 and FDA guidancedocument Radio Frequency Wireless Technology in MedicalDevices.	Pass
Electrical Safety	In accordance with ANSI/AAMI ES60601-1:2005/(R)2012and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012(Consolidated Text)	Pass
EMC Testing	In accordance with IEC60601-1-2 Edition 4.0 2014-02	Pass
Usability	Product was designed and tested per IEC 60601-1-6 Edition3.1 2013-10 and ANSI/AAMI/IEC 62366-1:2015	Pass
Systemvalidation andsimulated usertesting	Validated system performance in accordance with defined userneeds and device performance specifications	Pass
SoftwareValidation &Verification	In accordance with IEC 62304 and FDA Guidance DocumentPrinciples of Software Validation	Pass
Test	Method	Results
Cybersecurityverification andNetwork scan	In accordance with device performance specifications, cybersecurity risk assessment and FDA guidance documents -Content of Premarket Submissions for Management ofCybersecurity in Medical Devices	Pass

{7}------------------------------------------------

sti

NOTE: The Connected OR Hub with Device and Voice Control does not require clinical studies to support the determination of substantial equivalence.

Conclusion:

Based upon the indications for use, intended use, technological characteristic, performance testing and comparison to the predicate device, the Stryker Connected OR Hub with Device and Voice Control raises no new questions of safety and effectiveness as compared to the predicate device.

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.