The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control

The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

Device Description

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of comected endoscopic and general surgery devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components:

Base Console which includes:

a) Medical Device Data System (MDDS) functionalities

b) Optional Device Control feature

d) Optional Video Image Processing (VIP) feature

Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
Voice Control Package (software activation USB dongle and a wireless headset and base station)
Video Image Processing package (software activation USB dongle)
Connected OR Spoke (MDDS)

The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GU), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.

In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Medical Device Data System. Once the Connected OR Hub with Device and Voice Control or SDC4K Information Management System with Device and Voice Control is connected to the Spoke, Device Control can be extended to compatible devices which are directly connected to the Spoke.

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm, and removal of surgical smoke through a compatible insufflator.

AI/ML Overview

This FDA 510(k) summary for the Stryker Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical effectiveness measures for AI/ML performance.

Instead, this document focuses on non-clinical testing to establish the safety and performance of the device's voice and remote control functionalities and its compliance with relevant medical device standards. This device appears to be an enabling technology for controlling medical devices, rather than a diagnostic or prognostic AI/ML system that would typically have the kind of performance metrics you've requested.

Therefore, many of your requested items, such as expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and sample sizes for training sets, are not applicable (N/A) in the context of this specific device's submission summary.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not provided in a format that allows for a table of "acceptance criteria" and "reported device performance" in terms of diagnostic or clinical metrics. The document instead describes compliance with engineering and safety standards and successful verification and validation testing for its functionalities.

Acceptance Criteria (General): Conformity with recognized safety standards, design input specifications, user needs, and intended uses.
Reported Device Performance (General): Verification and validation testing successfully completed demonstrated that the device conforms with these requirements.

Without a specific performance metric (like accuracy, sensitivity, or specificity for a diagnostic task), a direct "performance" table cannot be constructed.

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

N/A. The document discusses "software function testing" and "verification and validation testing," but these are engineering tests, not clinical performance studies on patient data. There is no mention of a "test set" in the context of diagnostic or clinical data in this summary.

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)

N/A. As this is not a diagnostic device using AI for interpretation, there's no "ground truth" established by medical experts for a test set.

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

N/A. Not applicable, as there is no test set for clinical ground truth.

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

N/A. The document explicitly states: "The subject devices do not require clinical studies to support the determination of substantial equivalence." This confirms no MRMC study was conducted or required. The device's function is to control other medical devices via voice/remote, not to assist in interpretation.

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

N/A. This is not an AI algorithm for diagnostic interpretation in that sense. Its "intelligence" is in processing voice commands and mapping them to device controls. Its performance would be evaluated on the accuracy of carrying out those commands, not on a diagnosis.

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

N/A. The "ground truth" for this device's performance would relate to whether it accurately executes commands (e.g., "increase insufflator pressure" results in the correct pressure change) and whether it adheres to safety protocols. This is confirmed through engineering and software testing, not medical ground truth types.

8. The sample size for the training set

N/A. In the context of a diagnostic AI/ML device, this refers to the data used to train the model. This device's capabilities (voice control, device control) would involve training data for speech recognition models, but the 510(k) summary does not detail the specifics of such training or sample sizes for that purpose. It focuses on the validation of the system as a whole.

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

N/A. Similar to point 8, this level of detail is not provided for speech recognition components, given the nature of this 510(k) submission.

In summary, this document is for a medical device that provides control and information management functionalities, rather than an AI/ML-driven diagnostic or prognostic tool. Therefore, the typical metrics and study designs for evaluating AI/ML performance in clinical decision-making are not present here.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 18, 2023

Stryker Corporation Lauren Bentley Sr. Manager, Regulatory Affairs 5900 Optical Ct San Jose, California 95138

Re: K232157

Trade/Device Name: Connected OR Hub with Device and Voice Control, SDC4K Information Management System 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: July 19, 2023 Received: July 20, 2023

Dear Lauren Bentley:

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.

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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 and Part 809); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Mark Trumbore -S Mark Trumbore -S
Date: 2023.08.18 15:10:05 -04'00'

Mark Trumbore

Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use:

Connected OR Hub with Device and Voice Control:

SDC4K Information Management System with Device and Voice Control

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510(k) Summary

Prepared on: 2023-07-20

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	Stryker Corporation
Applicant Address	5900 Optical Ct San Jose CA 95138 United States
Applicant Contact Telephone	(408) 754-2473
Applicant Contact	Ms. Janki Bhatt
Applicant Contact Email	janki.bhatt@stryker.com
Correspondent Name	Stryker Corporation
Correspondent Address	5900 Optical Ct San Jose CA 95138 United States
Correspondent Contact Telephone	(484) 985-0736
Correspondent Contact	Ms. Lauren Bentley
Correspondent Contact Email	lauren.bentley@stryker.com

21 CFR 807.92(a)(2)

Device Trade Name	Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Common Name	Endoscope and accessories
Classification Name	Laparoscope, General & Plastic Surgery
Regulation Number	876.1500
Product Code	GCJ

21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K230886	Connected OR Hub with Device and Voice Control; SDC4K Information	GCJ

21 CFR 807.92(a)(4)
Device Description Summary
The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to controlThe Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components:

the state, selection, and settings of comected endoscopic and general surgery devices both wired and wirelessly.

Base Console which includes:

a) Medical Device Data System (MDDS) functionalities

b) Optional Device Control feature

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d) Optional Video Image Processing (VIP) feature
1. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
1. Voice Control Package (software activation USB dongle and a wireless headset and base station)
1. Video Image Processing package (software activation USB dongle)

Connected OR Spoke (MDDS)

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm, and removal of surgical smoke through a compatible insufflator.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

Connected OR Hub with Device and Voice Control:

The use of the Connected OR Hub with Device and Voice Control is to allow for voice control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control

The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control of medical device settings by surgeons or opersonnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the

surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

Indications for Use Comparison

The subject devices, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control have the same indications for use and intended use as the predicate devices.

Technological Comparison

The subject devices and the predicate devices (Connected OR Hub with Device Control and SDC4K information Management System with Device and Voice Control) have the same technological characteristics (i.e., principles of operation, components, features, user interface, controllable devices, software design, video input and output, communication protocol(s), wireless technology and electrical safety/EMC/with the exception of the Connected OR Hub and SDC4K Consoles' internal hardware components. The subject devices' internal hardware was replaced with similar components that provide the same functionality, hence considered similar in technology.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-clinical testing was designed and developed in accordance with applicable requirements and stablish performance and safety of the subject devices (Connected OR Hub with Device and Voice Control and SDC4K information Management System with Device and Voice Control). These include software function testing executed in accordance with IEC 62304:2015, Medical device software - Software ife-cycle processes (FDA recognized voluntary consensus standard: 13-79) as well as EMC and Electrical Safety testing in accordance with IEC 60601-1-22014+A1:2020, Medical Electrical Equipment - Part 1-2: General requirements for basic

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safety and essential performance – Colateral standard: Electromagnetic disturbances – Requirements and Tests (FDA-recognized voluntary consensus standard: 19-36) and IEC TR 60601-4-2 Edition 1.0 2016-05, Medical Electrical Equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems (FDArecognized voluntary consensus standard: 19-19), IEC 60601-1 Edition 3.2 2020-08 Consolidated Version equipment -Part 1: General requirements for basic satety and essential performance (FDA recognized voluntary consensus standard: 19-49) and IEC 60601-1-6:2010+A1:2013+A2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (FDA-recognized voluntary consensus standard: 5-132). Verification and validation testing successfully completed demonstrated that the device conform with recognized safety standards, design input specifications, user needs and intended uses.

The subject devices do not require clinical studies to support the determination of substantial equivalence.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device Control are the same or similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are the same or similar with respect to safety and effectiveness to the legally marketed predicate devices.

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.