The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, reaming, decorticating, shaping, and smoothing of bone cement and teeth in a variety of surgical procedures, including but not limited to dental. ENT (ear, nose, and 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 S2 Drill is an electric powered (40V DC) motor. When connected to the CORE console, it directly rotates cutting accessories up to speeds of 75,000 RPM.

AI/ML Overview

This document describes the Stryker S2 Drill, an electric powered surgical drill, and its substantial equivalence to a previously cleared predicate device, the Stryker CORE Sumex Drill. The document does not describe an AI/ML device, therefore, many of the requested criteria are not applicable.

Here's an analysis of the provided text in relation to your request:

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

The document does not specify formal 'acceptance criteria' in the quantitative sense typical for performance metrics of AI/ML devices. Instead, it demonstrates the device meets design input requirements through verification tests.

Performance Metric (Acceptance Criteria)	Reported Device Performance (Stryker S2 Drill)
Verification of improved rotor driveshaft	Tests performed, results demonstrate functionality, integrity, safety, and effectiveness.
Simulated use tests	Tests performed, results demonstrate functionality, integrity, safety, and effectiveness.
Temperature testing of different torque-speed setting	Tests performed, results demonstrate functionality, integrity, safety, and effectiveness.
Substantial Equivalence to Predicate Device (Stryker CORE Sumex Drill)	Deemed substantially equivalent in intended use, technological characteristics, safety, and effectiveness. Modifications raise no new issues of safety and effectiveness.

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

The document mentions "verification tests" and "simulated use tests" but does not specify the sample sizes used for these tests. There is no information regarding data provenance (country of origin, retrospective/prospective). This is non-clinical performance 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)

This is not applicable as the device is a physical surgical drill and not an AI/ML diagnostic or assistive device that would require expert-established ground truth on a test set. The "ground truth" here is the physical performance and safety of the device as measured by engineering tests.

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

Not applicable. This is not an AI/ML device requiring adjudication of output.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" used for this device involves engineering specifications, functional requirements, and safety standards for a surgical drill. This is established through internal design specifications and regulatory requirements. The tests performed verify that the device meets these pre-defined engineering and safety criteria.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria consists of non-clinical performance testing.

Tests Performed:
- Verification of the improved rotor driveshaft
- Simulated use tests
- Temperature testing of different torque-speed settings
Results: The results of these tests demonstrated that the functionality, integrity, safety, and effectiveness of the Stryker S2 Drill are sufficient for its intended use.
Conclusion: Based on these non-clinical tests, the Stryker S2 Drill was deemed substantially equivalent to the existing predicate device (Stryker CORE Sumex Drill) in terms of intended use, technological characteristics, safety, and effectiveness. The modifications introduced (e.g., changes in housing material, motor diameter, length, and weight) raised no new issues of safety and effectiveness.
Clinical Testing: No clinical testing was deemed necessary for this 510(k) submission, as substantial equivalence was established through non-clinical performance and engineering comparisons.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

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

September 26, 2014

Stryker Corporation Mr. Vishal Kanani Sr. Regulatory Affairs Representative 4100 E. Milham Avenue Kalamazoo, MI 49001

Re: K141935

Trade/Device Name: Stryker S2 Drill Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL, HBE, DZJ Dated: August 25, 2014 Received: August 27, 2014

Dear Mr. Kanani:

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.

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

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 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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

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

Indications for Use

510(k) Number (if known)

K141935

Device Name Styker S2 Drill

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 Druq 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 all capitalized except for the "t" and "y", which are lowercase. A registered trademark symbol is located to the right of the "r" in "Stryker". The word is in black and the background is white.

510(k) Summary

510(k) Owner:	Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-389-5412
Contact Person:	Vishal KananiSr. Regulatory Affairs Representative
Registration Number:	1811755
Date SummaryPrepared:	July 07, 2014
Trade Name(s):	Stryker S2 Drill

Common Name:

Classification Data:

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

	ProductCode	Device	RegulationNumber	Class	ReviewPanel
PrimaryCode	ERL	Drill, Surgical,ENT (Electric orPneumatic)IncludingHandpiece	21 CFR874.4250	II	Ear, Noseand Throat
SecondaryCodes	HBE	Drills, burs,trephines, andaccessories(simple,powered)	21 CFR872.4120	II	Neurology
	DZJ	Driver, wire,and bone drill,manual	21 CFR872.4120	II	Dental

Predicate Device:

510(k)number	Productcode	Trade name	Manufacturer
K112593	ERL	Stryker®ConsolidatedOperating RoomEquipment(CORE) System	StrykerInstruments

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

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

Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol to the right of the word. The word is in black and the background is white.

Indications for Use:	The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in 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, and 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 S2 Drill is an electric powered (40V DC) motor. When connected to the CORE console, it directly rotates cutting accessories up to speeds of 75,000 RPM.
Performance Data (Non Clinical Tests):	Following verification tests were performed which demonstrate that the design outputs of the modified device meet the design input requirements: Verification of the improved rotor driveshaftSimulated use testsTemperature testing of different torque-speed setting Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker S2 Drill is sufficient for their intended use and support a determination of substantial equivalence.
Clinical Tests:	No clinical testing was deemed necessary for this 510(k).
Conclusion/Substantial Equivalence (SE) Rationale:	The Stryker S2 Drill is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker CORE Sumex Drill. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications introduced raise no new issues of safety and effectiveness. Therefore, the Stryker S2 Drill is substantially

equivalent to the existing predicate device.

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

Image /page/5/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are all connected, and the word is in black. There is a registered trademark symbol to the right of the letter "r".

Summary of Substantial Equivalence Table
Description	Stryker CORE Sumex Drill (Predicate)	Stryker S2 Drill (Subject)
Intended Use	The Stryker Consolidated OperatingRoom Equipment (CORE) System isintended for use in cutting, drilling,reaming, decorticating, shaping, andsmoothing of bone, bone cement andteeth in a variety of surgicalprocedures, including but not limitedto, dental, ENT (ear, nose, andthroat), neuro, spine, and endoscopicapplications. It is also usable in theplacement or cutting of screws,metal, wires, pins, and other fixationdevices.	The S2 Drill is intended for use withthe Stryker Consolidated OperatingRoom Equipment (CORE) System.When used with a variety ofattachments and cutting accessories,the drill is intended for use indrilling, cutting, reaming,decorticating, shaping andsmoothing of bone, bone cementand teeth in a variety of surgicalprocedures, including but not limitedto ENT, neuro, spine and Endoscopicapplications. It is also usable in theplacement or cutting of screws,metal, wires, pins, and other fixationdevices.
Housing Material	Stainless Steel	Stainless Steel and Aluminum
Motor Diameter	20mm	17mm
Length of the drill	105mm	123.5mm
Weight of the drill	399g	313g
Power source	40V DC Electric Motor connected viacable to CORE console	40V DC Electric Motor connected viacable to CORE console
Speed	0-75,000 rpm	0-75,000 rpm
Attachment retentionmethod by drill	Mechanical lock activated by rotationof attachment onto drill	Mechanical lock activated byrotation of attachment onto drill
Mode of activation	Footswitch and Handswitch	Footswitch

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.