The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.

Device Description

The CORE 2 Console is a non-sterile, 120V AC-powered, reusable device that is intended for use outside of the sterile environment during surgery. The console supplies 40V DC power to a range of motors for use in a variety of surgical procedures as described in its labeling. It also provides a means for irrigation through an integrated irrigation pump. The console has three motor ports, two footswitch ports, and one irrigation cassette port. CORE 2 receives identification and configuration information from connected devices including Stryker handpieces, footswitches, cutting attachments with RFID, and irrigation cassettes. The console allows further device configuration through its graphical user interface (GUI).

The primary modules that comprise CORE 2 are its power supply, central processing unit, motor controller, irrigation pump controller, RFID module, liquid crystal display (LCD) screen and speaker, touchscreen, USB interface, and an Ethernet interface. The CORE 2 is responsible for the integration of these modules and control of the console's software receives identification and configuration from connected devices. This information is monitored and processed based on current system configurations, and can be used to activate handpiece motors, change motor speed, and activate or deactivate irrigation, among other functions.

The device modifications in scope of this premarket notification consist of updates to the CORE 2 software to allow for its use within a RISE (Reimagining Integrated Surgical Experience) ecosystem. RISE is an optional software functionality that allows for Ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System, and Sonopet iQ consoles) and utilizes the DCM (Device Communication Module) protocol.

RISE provides for an integrated OR (Operating Room) solution to healthcare facilities to simplify workflows and reduce OR clutter. In a RISE configuration, adjustment of CORE 2 power, irrigation, and handpiece settings can be made directly on a Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console. RISE functionality also allows for the activation of the subject device output via a remotely connected foot pedal. The functional output tasks that the software performs are the same as that of the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Consolidated Operating Room Equipment (CORE) 2 Console. However, the document does not contain specific acceptance criteria, reported device performance data, or details about a study that proves the device meets specific performance criteria in the way that would typically be presented with quantitative metrics (e.g., sensitivity, specificity, accuracy, precision).

The submission focuses on demonstrating substantial equivalence to a predicate device (CORE 2 Console, K241171) following a software modification. The core argument for safety and effectiveness relies on the fact that the "functional output tasks that the software performs are the same as that of the predicate device" and that "no changes made to the intended use, indications for use, design, materials, or fundamental scientific technology."

Instead of explicit acceptance criteria and corresponding performance metrics, the document outlines the types of testing performed to support the substantial equivalence claim:

Software and wireless technology testing per FDA guidance documents and recognized standards
EMC and Electrical Safety testing per FDA recognized standards
Bench testing per various internal protocols
Simulated use testing per various internal protocols
Human factors testing per FDA guidance documents and recognized standards

The "Conclusions Drawn from Testing Performed" states: "Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the subject device is sufficient for its intended use. Verification test results for the CORE 2 Console confirm that the differences in technology raise no new issues of safety or effectiveness when compared to the predicate device."

Therefore, based on the provided text, it is not possible to fill out the requested table or answer most of the detailed questions about acceptance criteria and quantitative study results. The submission is a regulatory document asserting substantial equivalence through comparison to a predicate, rather than a detailed report of a performance study against specific acceptance metrics.

Here's what can be extracted/inferred from the document given the constraints:

A table of acceptance criteria and the reported device performance:
- Cannot be provided as specific quantitative acceptance criteria and reported performance metrics are not detailed in the document. The general acceptance criterion is that the device "demonstrate that the modifications to the subject device are as safe and effective as the predicate" and "raise no new issues of safety or effectiveness."
Sample size used for the test set and the data provenance:
- Not specified. The document mentions "bench testing," "simulated use testing," and "human factors testing," but does not provide details on the number of samples, test cases, or data provenance (e.g., country of origin, retrospective/prospective).
- The testing described (Software and wireless technology testing, EMC and Electrical Safety testing, Bench testing, Simulated use testing, Human factors testing) are typically conducted in a controlled lab or simulated environment rather than with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Given the nature of the device (surgical console, not a diagnostic AI system), "ground truth" in the clinical sense established by experts is not described as part of the testing. The ground truth for engineering and performance testing would typically be engineering specifications and functional requirements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This pertains to clinical studies often involving human interpretation and consensus, which is not described here.
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 study was not done. This type of study is relevant for diagnostic AI systems with human-in-the-loop components. The CORE 2 Console is a surgical instrument console with software modifications for integration into an operating room ecosystem, not a diagnostic imaging AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not explicitly detailed as such. While the software itself was tested, it's not a standalone diagnostic algorithm that would typically be evaluated without human interaction. Its performance is tied to its function as a controller for surgical tools. The testing described (software, EMC, bench, simulated use, human factors) would cover the "standalone" functional behavior of the software and hardware components.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred: The ground truth for the various engineering and performance tests (software, EMC, bench, simulated use) would likely be engineering specifications, functional requirements, and recognized industry standards. For "human factors testing," the ground truth relates to usability and safety heuristics / guidelines. Clinical ground truth like pathology or outcomes data is not mentioned as being used for this specific submission's testing.
The sample size for the training set:
- Not applicable/Not specified. This device is not described as an AI/ML device that requires a "training set" in the context of machine learning model development. This is a traditional software and hardware update submission.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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March 21, 2025

Stryker Instruments Leandra Burke Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002

Re: K243958

Trade/Device Name: Consolidated Operating Room Equipment (CORE) 2 Console Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, ERL, HWE, HBE Dated: December 20, 2024 Received: December 23, 2024

Dear Leandra Burke:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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

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by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243958

Device Name

Consolidated Operating Room Equipment (CORE) 2 Console

Indications for Use (Describe)

The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surqical procedures on the spine in adult and pediatric (adolescent) patients.

Type of Use (Select one or both, as applicable)

< Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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510(k) Summary - K243958
--------------------------

807.92(a)(1) - Submitter Information
510(k) Submitter:	Stryker Instruments1941 Stryker Way,Portage, MI 49002, USA
Contact Information:	Leandra BurkeStaff Regulatory Affairs SpecialistTel: (269) 823-4639Email: leandra.burke@stryker.com
Date Summary Prepared:	20 December 2024

807.92(a)(2) – Name of Device
Trade Name:	Consolidated Operating Room Equipment (CORE) 2 Console
Classification Name:	Orthopedic Stereotaxic Instrument
Device Class:	Class II (21 CFR 882.4560)
Product Code(s):	OLO (Secondary ERL, HWE, HBE)

807.92(a)(3) - Legally marketed device to which equivalence is claimed

CORE 2 Console (K241171)

807.92(a)(4) - Device Description

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compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System, and Sonopet iQ consoles) and utilizes the DCM (Device Communication Module) protocol.

807.92(a)(5) - Intended Use of the Device

Indications for Use

The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.

807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the Predicate

There have been no changes made to the intended use, indications for use, design, materials, or fundamental scientific technology of the CORE 2 Console. The device has undergone a software modification to enable its use within a RISE ecosystem. The following table identifies technological characteristics shared between the subject and predicate devices.

Feature	Predicate Device (K241171)	Subject Device
Indication(s)	The Stryker Consolidated OperatingRoom Equipment (CORE) 2Console is intended for use in thecutting, drilling, reaming,decorticating, shaping, andsmoothing of bone, bone cement andteeth in a variety of surgicalprocedures, including but not limitedto orthopedic, dental, ENT (Ear,Nose, Throat), neuro, spine, andendoscopic applications. Theconsole is also usable in theplacement or cutting of screws,metal, wires, pins, and other fixationdevices.The CORE 2 Console is alsoindicated as an accessory to the	Same

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	Stryker Spine Guidance Software forstereotactic surgical procedures onthe spine in adult and pediatric(adolescent) patients.
Conditions of Use	Non-sterile, reusable, outside ofsterile environment during surgeries.	Same
For Use With	Various handpieces, footswitches,irrigation cassettes, and bone mill.	Same
Outer Profile	Bench-top style console with aliquid crystal display screen andirrigation pump (use of pump isoptional). Coated sheet metalhousing.	Same
Dimensions(W x D x H)	13.0 x 17.4 x 5.4"	Same
Weight	17.3lbs	Same
Energy Source	AC powered from mains supplythrough detachable cord	Same
Internal PCBAs(Hardware)	Four-channel RFID module,irrigation pump controller, maincontroller, power button, motorcontroller, handpiece / footswitch,port illumination	Same
User Interface	Color LCD screen allows the user toset the desired operating parameters.Capacitive touchscreen interfacewith GUI workflow.	Same
Irrigation	Forced, via peristaltic pump	Same
Connectivity	Ethernet port - service, connectionfor communication with compatibleStryker devices	Same

The following differences between the subject and predicate devices were considered in the determination of substantial equivalence:

CORE 2 software update to enable its use within a RISE ecosystem. .
Additional mapping indicators for handpiece and footswitch ports.

807.92(b)(1) - Nonclinical Testing to Support Submission

The following testing was conducted to demonstrate that the modifications to the subject device are as safe and effective as the predicate:

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· Software and wireless technology testing per FDA guidance documents and recognized standards
· EMC and Electrical Safety testing per FDA recognized standards
· Bench testing per various internal protocols
· Simulated use testing per various internal protocols
· Human factors testing per FDA guidance documents and recognized standards

807.92(b)(2) – Clinical Testing

No clinical testing was required to support this submission.

807.92(b)(3) - Conclusions Drawn from Testing Performed

Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the subject device is sufficient for its intended use. Verification test results for the CORE 2 Console confirm that the differences in technology raise no new issues of safety or effectiveness when compared to the predicate device.

Conclusion/ Substantial Equivalence (SE) Rationale:

The subject devices, in comparison with the legally marketed predicate, has the same intended use, indications for use, operating principles, energy source, and functional outputs. Performance testing and risk analysis demonstrate that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).