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 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.

Device Description

The Stryker CORE 2 Console is a modernization of the currently marketed CORE Console. The CORE 2 Console supplies power to a variety of devices, which include small and large bone handpieces, footswitches, and a bone mill. The CORE 2 Console contains a touch screen graphical user interface (GUI), which allows the user to program a number of customized settings related to the connected devices and irrigation.

AI/ML Overview

This FDA 510(k) summary is for the Stryker Consolidated Operating Room Equipment (CORE) 2 Console. It asserts substantial equivalence to a predicate device (Stryker Consolidated Operating Room Equipment (CORE) System, K112593) rather than defining specific acceptance criteria for a novel device and then proving it meets them. Therefore, many of the requested categories related to algorithmic performance and ground truth establishment are "Not Applicable" or "Not Provided" in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, explicit quantitative acceptance criteria for novel performance metrics are not specified in the document. Instead, the focus is on demonstrating that the device meets established regulatory standards and performs comparably to its predicate.

Category	Acceptance Criteria (Implied / Stated)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1	The device complies with the IEC 60601-1 standard for safety.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	The device complies with the IEC 60601-1-2 standard for EMC.
Software Verification & Validation	Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern)	Software verification and validation testing was conducted, and documentation was provided as recommended by FDA guidance.
Mechanical Performance	Correct functionality of the console as specified, reliability, use life, compatibility with accessories, torque mapping, capacitive touchscreen.	Design verification activities performed to ensure correct functionality: Reliability and Use Life Testing, Compatibility Testing, Performance testing for torque mapping capability and capacitive touchscreen. Results are not quantified but assumed to be acceptable.
Human Factors/Usability	Compliance with FDA's "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and IEC 62366-1	Human factors analysis and usability testing was performed in accordance with the specified FDA guidance and IEC standard.
Biocompatibility	No direct or indirect patient contact (matching predicate)	Not required as the CORE 2 Console is identical to the predicate device in that there are no components with direct or indirect patient contact.
Clinical Performance	Not applicable for this device as per the submission.	Not applicable – data from clinical studies was not provided. Clinical studies are not required to demonstrate safety or feasibility.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for any of the performance tests. The document broadly states "Reliability and Use Life Testing," "Compatibility Testing," and "Performance testing for torque mapping capability and capacitive touchscreen" were conducted but does not provide numbers of units tested or duration of tests.
Data Provenance: Not explicitly stated, but given it's a device manufacturer submitting to the FDA, it is presumed to be internal testing data from the company's facilities. The document does not indicate country of origin of data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable/Not Provided. For a device of this nature (surgical console), "ground truth" usually refers to the accuracy or correctness of an AI algorithm's output relative to established medical fact. As this is not an AI-driven diagnostic or prescriptive device, and the submission is focused on substantial equivalence of hardware/software functionality, this concept of "ground truth" in the context of expert review does not apply directly. The performance tests would be validated against engineering specifications and industry standards by qualified engineers and testers.

4. Adjudication Method for the Test Set

Not Applicable/Not Provided. Adjudication methods (like 2+1, 3+1 for consensus) are typically used in clinical studies or for evaluating AI diagnostic performance where human expert discrepancy needs resolution. This submission focuses on engineering and regulatory compliance, not clinical diagnostic accuracy requiring expert consensus adjudication.

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 not conducted as this is not an AI-assisted diagnostic or interpretation device that would involve human "readers" or image interpretation. The device is a surgical console that powers other instruments.

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

Not Applicable. This is not an AI-driven algorithm with a "standalone" diagnostic or predictive function. The software mentioned "accommodate internal circuitry redesigns" and manages "illumination rings," "GUI workflow," and "transfer saved use-preference profiles." The "software verification and validation testing" would assess the standalone functionality of the software's control over the console's operations, but not in the sense of an "AI algorithm."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Engineering Specifications and Regulatory Standards. For this device, the "ground truth" for its performance tests would be adherence to documented engineering specifications and compliance with relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2) and the stated indications for use.

8. The Sample Size for the Training Set

Not Applicable/Not Provided. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. The "software was rewritten" and verified/validated, but this refers to traditional software development, not AI model training.

9. How the Ground Truth for the Training Set was Established

Not Applicable/Not Provided. As there is no "training set" for an AI model, this question is not relevant to this submission.

Summary

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

September 15, 2017

Stryker Corporation Nicholas Werner Senior Staff Regulatory Affairs Specialist 4100 E. Milham Ave. Kalamazoo, MI 49001

Re: K171840

Trade/Device Name: Stryker Consolidated Operating Room Equipment (CORE) 2 Console Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL Dated: June 19, 2017 Received: June 20, 2017

Dear Nicholas Werner:

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 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); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education (DICE) 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" (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 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 Industry and Consumer Education (DICE) 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.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Stryker Instruments

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171840

Device Name

Stryker Consolidated Operating Room Equipment (CORE) 2 Console

Indications for Use (Describe)

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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Section 5 - 510(k) Summary

Prepared: 19 June 2017

I. SUBMITTER

Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 Phone: 269-389-2971

Contact: Nicholas Werner

II. DEVICE

Name of Device:	Stryker Consolidated Operating Room Equipment (CORE) 2Console
Common/Usual Name:	Console
Regulation Numbers:	21 CFR 874.4250
Regulation Name:	Drill, Surgical, ENT (Electric or Pneumatic)
Regulatory Class:	II
Product Codes:	ERL

III. PREDICATE DEVICE

Primary Predicate

Stryker Consolidated Operating Room Equipment (CORE) System, K112593

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

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, 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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following table identifies technological characteristics shared between the Predicate and Subject device:

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Section 5 – 510(k) Summary

	Predicate Device	Subject Device
Indications for Use	Intended for use in the cutting,drilling, reaming, decorticating,shaping, and smoothing of bone, bonecement and teeth in a variety ofsurgical procedures, including but notlimited to, dental, ENT (ear, nose,throat), neuro, spine, and endoscopicapplications. It is also usable in theplacement or cutting of screws, metal,wires, pins, and other fixation devices.	Same
Contraindications	None known	Same
For use with	Various small and large bonehandpieces, footswitches, and a bonemill.	Same
Patient Contact	No direct or indirect patient contact	Same
Power Output	Handpiece port output voltage: 40VFootswitch port output voltage: 5V	Same
Electrical Isolation Type	Class I, Type BF Applied Part	Same
Electrical Safety & EMC	Tested and compliant with IEC60601-1, IEC 60601-1-2	Same
Irrigation	Irrigation Pump and Pump Controller -A DC brush motor with an opticalencoder is used to create a peristalticpump. A micro-controller measuresmotor speed from the encoder andadjusts the supply voltage to themotor appropriately to achieve thedesired speed. Start, stop, and speedindications are received from the mainprocessor.	Same
User Interface	A color LCD screen allows the user toset the desired operating parameters.Touchscreen interface with GUIworkflow.	Same
	Predicate Device	Subject Device
Software	Microprocessor	Same
Wireless Tag Technology(RFID)	Certain accessories are recognized andidentified on the console screen.	Same

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Section 5 – 510(k) Summary

The following differences between the subject and predicate device were considered in relation to the substantial equivalence determination:

CORE 2 handpiece and footswitch ports have illumination rings that serve as secondary . identifiers for mapping.
CORE 2 has a modified GUI workflow designed to be less complex.
CORE 2 has a capacitive touchscreen interface. ●
Users are able to transfer saved use-preference profiles via USB between consoles if desired.
The software of CORE 2 was rewritten to accommodate internal circuitry redesigns.

VII. PERFORMANCE TESTING

The following performance testing was conducted to support substantial equivalence:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the CORE 2 Console. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Mechanical Testing

The following design verification activities have been performed to ensure the correct functionality of the console as it has been specified:

Reliability and Use Life Testing
Compatibility Testing (with defined accessories) ●
. Performance testing for torque mapping capability and capacitive touchscreen

Human Factors Evaluation

Human factors analysis and usability testing was performed in support of the Substantial Equivalence determination and in accordance with FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and IEC 62366-1 "Medical Devices – Application of Usability Engineering to Medical Devices."

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Section 5 - 510(k) Summary

Biocompatibility

Biocompatibility data is not required to support a Substantial Equivalence determination as the CORE 2 Console is identical to the predicate device in that there are no components with direct or indirect patient contact.

Animal Study

Not Applicable – data from animal studies was not provided to support the Substantial Equivalence determination. Animal studies are not required to demonstrate safety or feasibility of the CORE 2 Console.

Clinical Studies

Not Applicable – data from clinical studies was not provided to support the Substantial Equivalence determination. Clinical studies are not required to demonstrate safety or feasibility of the CORE 2 Console.

VIII. CONCLUSIONS

The differences that exist between the CORE 2 Console and its predicate do not raise different questions of safety or effectiveness. The results of non-clinical performance testing demonstrate that the CORE 2 Console will perform as intended and is substantially equivalent to the predicate device which is marketed for the same intended use.

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.