The Stryker ® Consolidated Operating Room Equipment (CORE) System 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. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

Device Description

The Stryker Consolidated Operating Room Equipment (CORE) System is an electrically powered system. This system includes a console, irrigation accessories, footswitches, handswitches, and handpiece cords which drive a variety of devices including saws, drills, wire drivers, microdebriders, and bone mills.

AI/ML Overview

The provided text is a 510(k) summary for the Stryker® Consolidated Operating Room Equipment (CORE) System. This document details the device description, indications for use, and a comparison to predicate devices to establish substantial equivalence. It is not a study that proves the device meets specific performance acceptance criteria in terms of diagnostic accuracy or a similar measure typically associated with AI/software performance studies.

Therefore, many of the requested categories for AI/software-centric studies (e.g., sample size, ground truth, expert qualifications, MRMC comparative effectiveness, standalone performance) are not applicable to this document. The document describes a medical device (a surgical console) and its accessories, not an AI or software algorithm designed for diagnostic or analytical tasks.

However, I can extract information related to the device's "performance" in the context of its regulatory submission, which focuses on safety and effectiveness compared to predicate devices.

Here's the breakdown of the information available in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a physical surgical console, "acceptance criteria" here refers to demonstrating safety and effectiveness compared to predicate devices, rather than specific performance metrics like sensitivity or specificity.

Aspect of Performance/Comparison	Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance/Characteristics
Intended Use	Similar to predicate devices.	The Stryker® CORE System is intended for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement, and teeth in various surgical procedures (dental, ENT, neuro, spine, endoscopic), and the placement/cutting of screws, metal, wires, pins, and other fixation devices. This is stated to be similar across all predicate devices.
Technology Characteristics	Similar to predicate devices.	Power Output: 400 Watts (identical to Stryker® System and TPS). Handpiece Connectors: Three, allowing two handpieces simultaneously (identical to Stryker® System, more than Synthes EPD). Footswitch Connectors: Two, allowing two footswitches simultaneously; capable of wireless footswitch (more flexible than Synthes EPD or TPS, but similar general function). Adjustable Operating Parameters: LCD screen for user-set parameters, also obtained from accessories (similar software feature to TPS and previously-cleared CORE Console). Wireless Tag Technology: Accessories recognized and identified on console screen (similar software feature to TPS and previously-cleared CORE Console). Torque Control: Mechanism to allow user to specify torque profile (similar to Synthes EPD System).
Safety and Effectiveness	Does not raise any new issues of safety and effectiveness compared to legally marketed predicate devices.	"The results of this testing demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device." "The Stryker® Consolidated Operating Room Equipment (CORE) System does not raise any new issues of safety and effectiveness and is substantially equivalent to legally marketed devices."
Software Review	Undergoes code review, error messaging evaluation, adherence to standards, and analysis of new hazards and software requirements.	Each software revision underwent "a code review by a team of internal experts," evaluation of error messaging, and verification of adherence to standards. Analysis of new hazards and software requirements was performed. Documented in SRS and risk analysis.
Verification/Validation Testing	System and Unit box testing to confirm continued safety and effectiveness.	Subsequent verification/validation testing, including system and Unit box testing, was performed.
Biocompatibility	Not required for non-patient contact devices.	"A biocompatibility evaluation for the CORE Console is not required due to the non-patient contact intended use of this medical device."

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

Not applicable. This document describes a surgical console, not an AI/software device that processes data for diagnostic or analytical tasks. The "testing" mentioned refers to engineering, software V&V, and comparison to predicate devices, not clinical studies with patients or data sets in the typical sense this question implies for AI.

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)

Not applicable. No ground truth in the context of diagnostic accuracy is established for this device. The software review was done by "a team of internal experts," but their qualifications are not specified beyond that, and it's for code review, not clinical ground truth.

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

Not applicable. No clinical test set requiring adjudication in this sense is described.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not a standalone algorithm.

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

Not applicable. No clinical ground truth is described in this document. The "ground truth" for the device's functionality would be adherence to engineering specifications and regulatory requirements.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning.

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

Not applicable. This device does not have a training set.

Summary

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

MAY - 1 2012

stryker

4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 269 389 5412
www.stryker.com

Instruments ·

510(k) Summary

510(k) Owner:	Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-389-5412
Contact Person:	Michelle Jump
Registration No.:	1811755
Trade Name:	Stryker® Consolidated Operating Room Equipment (CORE) System
Common Name:	Console
Classification Name and Regulation Number	Primary Product Code
	PRODUCT CODE	DEVICE	REGULATION NUMBER	CLASS	REVIEW PANEL
	ERL	Drill surgical ent(electric or pneumatic)including handpiece	21 CFR874.4250	II	EAR NOSETHROAT
	Secondary Product Codes
	PRODUCT CODE	DEVICE	REGULATION NUMBER	CLASS	REVIEW PANEL
	DZI	Drill, bone, powered	21 CFR872.4120	II	DENTAL
	DZJ	Driver, wire, and bonedrill, manual	21 CFR872.4120	II	DENTAL
	HBE	Drills, burs, trephines& accessories (simplepowered)	21 CFR882.4310	II	NEUROLOGY
Predicate Devices:	Stryker® Consolidated Operating Room Equipment (CORE) System(K040300, K040369, K032303); Synthes Electric Pen Drive (EPD) System (K043310);and Stryker® Total Performance System (K032117, K942956, K943589, K943569,K943540)
Device Description:	The Stryker Consolidated Operating Room Equipment (CORE) System is anelectrically powered system. This system includes a console, irrigation accessories,footswitches, handswitches, and handpiece cords which drive a variety of devices

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

including saws, drills, wire drivers, microdebriders, and bone mills.
Indications for Use:	The Stryker ® Consolidated Operating Room Equipment (CORE) System is intendedfor 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 todental, ENT (ear, nose, throat), neuro, spine, and endoscopic applications. It is alsousable in the placement or cutting of screws, metal, wires, pins, and other fixationdevices.
Testing	The clarification of the Stryker® Consolidated Operating Room Equipment (CORE)System indications for use statement is not the result of any design changes that havebeen made to the console. In addition, the use of this device in orthopedic and spineapplications do not present any new risks that would require testing. Therefore, noadditional performance testing was performed to evaluate this change.
Each software revision of the Stryker® CORE Console has undergone a code reviewby a team of internal experts to review source code, evaluate error messaging, andverify adherence to standards. An analysis of new hazards and software requirementsemerging as a result of the changes is evaluated for each revision. This isdocumented in the CORE Console's Software Requirements Specifications (SRS) andrisk analysis, which can be found in Section 16. Subsequent verification/ validationtesting, including system and Unit box testing, is performed on the console to confirmthe continued safety and effectiveness of the Stryker® CORE Console prior to therelease of each software revision to the market.
The results of this testing demonstrate that the device is as safe, as effective, andperforms as well as or better than the predicate device.
Biocompatibility	Per ISO 10993-1:2003 and FDA G95-1:1995 guidelines, a biocompatibilityevaluation for the CORE Console is not required due to the non-patient contactintended use of this medical device.
SubstantialEquivalence(SE) Rationale:	The Stryker® Consolidated Operating Room Equipment (CORE) System whencompared to its predicates has a similar intended use and technology characteristicsas the predicate devices. Therefore, this device is substantially equivalent to predicatedevices.
Predicate Device Comparison Table
Element ofComparison	Stryker ® COREConsole (UnderReview)	Stryker ®System(K040300,K040369,K032303)	Synthes Electric PenDrive (EPD) System(K043310)	Stryker ® TotalPerformance System(TPS) (K942956,K943589, K943569,K943540, K032117)	SubstantialEquivalence
Indications for Use	The Stryker ®Consolidated OperatingRoom Equipment(CORE) Console isintended for use in thecutting, drilling,reaming,decorticating, shaping,and smoothing of bone,bone cement and teethin a variety of surgicalprocedures, includingbut not limited todental, ENT, neuro,spine, and endoscopicapplications. It is alsousable in the placementor cutting of screws,	The Stryker®ConsolidatedOperatingRoom Equipment(CORE) System isintended for use inthe cutting,drilling, reaming,decorticating, andsmoothing ofbone, bonecement and teethin a variety ofsurgicalprocedures,including but notlimited to dental,ENT, neuro, andendoscopic	The Synthes ElectricPen Drive (EPD)System is indicated forscrew insertion, pinand wire placement,cutting of bone andmetal, drilling,reaming, decorticating,shaping, andsmoothing of bonesand teeth in a widevariety of surgicalprocedures, includingbut not limited togeneral orthopedictrauma, foot, hand,maxifacial,neurosurgical, oral,	The Stryker ® TotalPerformance System isintended for use in thecutting, drilling,reaming,decorticating, andsmoothing of bone,teeth and other bonerelated tissue in avariety of surgicalprocedures,including but notlimited to dental, ENT,neuro and endoscopic.It isalso usable in theplacement or cutting ofscrews, wires, pins,	The indications foruse for all threedevices are similar.
	other fixation devices.	applications. It isalso usable in theplacement orcutting of screws,metal, wires, pins,and other fixationdevices.	reconstructive andspine surgery.	devices. It can also beused to cut metal.
HandpieceConnectors	Three connectors allowhandpiece cords to beconnected to theconsole. The console iscapable of running twohandpiecessimultaneously.	Three connectorsallow handpiececords to beconnected to theconsole. Theconsole is capableof running twoHandpiecessimultaneously.	Two connectors allowfor two Electric PenDrive units to beconnected.	Three connectors allowhandpiece cords to beconnected to theconsole.	Similar for all threedevices.Design feature isidentical topreviously-clearedStryker® COREConsole.
FootswitchConnectors	Two connectors allowup to two footswitchesto be run on theconsole simultaneously.The console can alsobe controlled by awireless footswitch.	Two connectorsallow up to twofootswitches to berun on the consolesimultaneously.	One connector allowsone footswitch tocontrol one drive unit.	One connector allowsone footswitch tocontrol one drive unit.	Similar for all threedevices. Stryker®CORE Consoleunder review hasthe capability ofconnecting to awirelessfootswitch.
AdjustableOperatingParameters	The LCD screen allowsthe user to set thedesired operatingparameters. Operatingparameters are alsoobtained from attachedaccessories.	The LCD screenallowsthe user to set thedesired operatingparameters.Operatingparameters arealso obtained fromattachedaccessories.	Max speed may becontrolled using slidecontrols provided in theconsole for each driveunit. Torque limitingfeature can becontrolled using an On/Off/Calibrate knob.Irrigation can be usedwith either Drive Unit 1or Drive Unit 2 andknob control isavailable to selectbetween continuousand variable irrigationfor each drive unit.Irrigation flow can becontrolled using a flowrate adjustment knob.ORUser sets the operatingparameters using thecontrols available inthe console or usingthe handswitch orfootswitch interface.	The LCD screen allowsthe user to set thedesired operatingparameters.	TPS and COREConsole havesimilar softwarefeature.Design feature isidentical topreviously-clearedStryker® COREConsole.
Power Output	400 Watts	400 Watts	Information notavailable.	400 Watts	TPS and COREConsole poweroutput is identical.Design feature Isidentical to .previously-clearedStryker® COREConsole.
Wireless TagTechnology	Accessories arerecognized andidentified on theconsole screen.	Accessories arerecognized andidentified on theconsole screen.	Information notavailable.	Accessories arerecognized andidentified on theconsole screen.	TPS and COREConsole havesimilar softwarefeature. Designfeature is identicalto previously-cleared Stryker®CORE Console.
Torque Control	Mechanism to allow theuser to specify thetorque profile to beused for handpieces.	N/A	Mechanism to allowthe surgeon to implantand tighten screwsunder power. The usercalibrates and sets thedesired torque valueusing the controlavailable in theconsole.	N/A	The Stryker®CORE Consoleand SynthesElectric Pen DriveSystem torquecontrol featuresare similar. Bothdevices allow theuser to vary torquesettings.

. . .

. |

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

・

、 .

・

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

Console Accessories	Irrigation accessories Handpiece cord Handswitch Footswitch	Irrigation accessories Handpiece cord Handswitch Footswitch	Irrigation accessories Handpiece cord Handswitch Footswitch	Irrigation accessories Handpiece cord Handswitch Footswitch	Similar for all three devices.
---------------------	-------------------------------------------------------------	-------------------------------------------------------------	-------------------------------------------------------------	-------------------------------------------------------------	--------------------------------

Safety and Effectiveness:	Based upon the comparison to the predicate devices, the Stryker® Consolidated Operating Room Equipment (CORE) System does not raise any new issues of safety and effectiveness and is substantially equivalent to legally marketed devices.
Submitted by:	Michelle JumpSenior Regulatory Affairs Representative

Signature

Date Submitted:	May 1, 2012
-----------------	-------------

and the comments of the comments of

and the country of the country of the country

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle.

Public Health Service

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

MAY - 1 2012

Stryker Corporation % Ms. Michelle Jump 4100 E. Milham Avenue Kalamazoo, MI 49001

Re: K112593

Trade/Device Name: Stryker® Consolidated Operating Room Equipment (CORE) System 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: April 24, 2012 Received: May 1, 2012

Dear Ms. Jump:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 read on as made a determination that your device complies with other requirements of the Act

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Edith m.b

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

Enclosure

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

Indications for Use

510(K) Number: K 112593

Device Name: Stryker® Consolidated Operating Room Equipment (CORE) System

Indications for Use:

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

D.M.ls

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number K1125

Section 4 -1

.. 21 CFR 801.109)

otion Use _

Prescription Use (Per 21 CFR 801.109)

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.