The Stryker® Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting. tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial and sternotomy surgeries.

Device Description

The Stryker® Maestro Air™ Motor(s) is a pneumatic motor powered by a regulated gas source. When connected to a gas source via tubing, the pneumatic motor operates at a normal operating pressure up to 150-psi (per square inch). The motor speed is controlled by a handswitch or a footpedal that connects to the motor and to a regulated gas source.

AI/ML Overview

This 510(k) summary describes a medical device, the Stryker® Maestro™ Air Motors, which is a pneumatic cranial drill motor. It does not involve any AI/ML components or describe a study related to AI/ML device performance. Therefore, the specific questions regarding AI/ML acceptance criteria, sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be answered from the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Stryker Maestro Pneumatic System, K041754) based on non-clinical performance testing.

Here's an analysis of the provided text, addressing what can be answered:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for each performance metric in a pass/fail sense. Instead, it states that "The results of the performance testing demonstrate that the functionality, integrity and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of substantial equivalence to the predicate device."

However, we can infer performance comparisons from Table 6-1, which compares the subject device to the predicate device. These comparisons implicitly serve as "performance criteria" for demonstrating substantial equivalence.

DESCRIPTION	Predicted Acceptance Criteria (Based on Predicate)	Reported Device Performance (Stryker® Maestro Air™ Motors)
Classification of Device	Class II	Class II
Regulation	21 CFR 882.4370; Pneumatic Cranial Drill Motor	21 CFR 882.4370; Pneumatic Cranial Drill Motor
Product Code	HBB	HBB
Power source	Dry, Filtered, Compressed air or nitrogen	Dry, Filtered, Compressed air or nitrogen
Patient Population	General	General
Contraindications	None known	None known
Motor Type	High Speed, High Torque, Pneumatic Vane	High Speed, High Torque, Pneumatic Vane
Mode of Action	Footpedal and Handswitch	Footpedal and Handswitch
Operating Speed	Up to 75,000 rotations per minute	Up to 75,000 rotations per minute
Stall Torque	5.6 in-oz. @ 150 psi (per square inch)	6.7 in-oz. @ 150 psi (per square inch)
Maximum Operating Pressure	120 psi (per square inch)	Up to 150 psi (per square inch)
Grip Design	Smooth	Knurled (Different, but likely considered acceptable as a design feature, not functional)
Router Retention Mechanism	Friction	Spring Collar (Different, but likely considered acceptable as a design feature)
Method of Sterilization	Moist Heat (Steam)	Moist Heat (Steam)
Sterility Assurance Level (SAL)	10-e (likely 10^-6)	10-e (likely 10^-6)
Method of Packaging	Packaged in a polybag case configuration	Packaged in a sealed air Korrvu retention Insert configuration (Different packaging method)
Cleaning Method	Manual	Manual and Mechanical (automated) (Expanded cleaning method)
Weight of the Motor and Hose	2.05 lb.	1.65 lb. (Lighter)
Housing Material	Stainless Steel	Stainless Steel and Aluminum (Different materials)
Pneumatic Hose Assembly	Exhaust Hose: Flurosilicone Inlet Hose: Nitrile rubber	Exhaust Hose: Flurosilicone with silicone jacket and Slick Sil coating Inlet Hose: Nitrile rubber and neoprene (Different hose materials/coatings)

Study that proves the device meets the acceptance criteria:

The study performed was a set of non-clinical verification tests. These tests included:

Reliability Testing (Motor body, Handswitch mounting, Router Retention, Pneumatic Hose assembly and automated washing)
Packaging Testing
Cleaning Testing
Sterilization Testing

The results of these tests demonstrated that the functionality, integrity, and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of substantial equivalence.

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 does not specify exact sample sizes for the non-clinical tests (e.g., how many motors were tested for reliability). It only lists the types of tests performed. It also does not provide information on data provenance in terms of country of origin or retrospective/prospective nature, as these are non-clinical engineering tests, not patient studies.

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. This is a submission for a mechanical device based on non-clinical engineering tests, not an AI/ML device requiring expert-established ground truth from medical images or clinical data.

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

Not applicable, as ground truth establishment by experts for a test set is not relevant to this type of device submission.

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 and no MRMC study was performed.

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)

Not applicable. For this mechanical device, the "ground truth" for performance is established through engineering specifications, validated test methods (e.g., measuring torque, speed, pressure resistance), and established industry standards for sterilization, packaging, and cleaning.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

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

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus with three intertwined snakes forming a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

May 22, 2015

Stryker Instruments Mr. Deval Patel Senior Regulatory Affairs Specialist 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K150801

Trade/Device Name: Stryker® Maestro™ Air Motors Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic cranial drill motor Regulatory Class: Class II Product Code: HBB Dated: April 29, 2015 Received: April 30, 2015

Dear Mr. Patel:

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 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

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

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/ResourcesforYou/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.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K150801

Device Name Stryker Maestro Air Motors

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.

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 Drug 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."

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

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

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

Image /page/3/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 likely a company logo or brand name.

510(k) Summary

Applicant	Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001US
Contact	Deval PatelSenior Regulatory Affairs SpecialistPhone: (269) 389- 5671E-mail: Deval.Patel@stryker.com
Registration Number	1811755
Date Summary Prepared	March 25, 2015
Trade Name	Stryker® Maestro Air™ Motors
Common Name	Pneumatic Cranial Drill Motor
Classification Data	21 CFR 882.4370, Pneumatic Cranial Drill Motor,Product Code HBB, Class II 510(k)
Predicate Device	Stryker Maestro Pneumatic System, K041754
Indication for Use	The Stryker® Consolidated Operating RoomEquipment (CORE ™ ) Maestro Air PneumaticSystem is a pneumatically operated surgicalinstrument system. The pneumatic motor providespower to operate removable rotating surgicalcutting tools and their accessories intended for usein neurosurgery, including craniotomy and spinalsurgery; as well as ear, nose and throat (ENT),orthopedic, and general surgical applicationsincluding maxillofacial, craniofacial andsternotomy surgeries.

...1

STRYKER® MAESTRO AIR™ MOTORS

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

t: 269 323 7700 f: 269 389 5412 www.stryker.com The Stryker® Maestro Air™ Motor(s) is a pneumatic motor powered by a Device Description regulated gas source. When connected to a gas source via tubing, the pneumatic motor operates at a normal operating pressure up to 150-psi (per square inch). The motor speed is controlled by a handswitch or a footpedal that connects to the motor and to a regulated gas source. Performance Data The results of the performance testing demonstrate that the (Non-Clinical Tests) functionality, integrity and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of substantial equivalence to the predicate device. The following verification tests were performed on the subject device to Summary of Performance demonstrate that the design outputs of the modified device meet the Testing design input requirements. ● Reliability Testing- Motor body, Handswitch mounting, Router Retention, Pneumatic Hose assembly and automated washing ● Packaging Testing ● Cleaning Testing ● Sterilization Testing Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of the substantial equivalence. No Clinical Test was deemed necessary for this 510(k). Clinical Test Predicate Comparison Please refer to Table 6-1: for the predicate comparison.

4100 E. Milham Ave. Kalamazoo, MI 49001

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

Table 6-1: Summary of Predicate Comparison

DESCRIPTION	STRYKER MAESTRO PNEUMATICSYSTEM [PREDICATE]K041754	STRYKER® MAESTRO AIR™ MOTORS[SUBJECT]
Classification of Device	Class II	Class II
Regulation	21 CFR 882.4370; PneumaticCranial Drill Motor	21 CFR 882.4370; Pneumatic CranialDrill Motor
Product Code	HBB	HBB
Power source	Dry, Filtered, Compressed air ornitrogen	Dry, Filtered, Compressed air ornitrogen
Patient Population	General	General
Contraindications	None known	None known
Motor Type	High Speed, High Torque,Pneumatic Vane	High Speed, High Torque, PneumaticVane
Mode of Action	Footpedal and Handswitch	Footpedal and Handswitch
Operating Speed	Up to 75,000 rotations per minute	Up to 75,000 rotations per minute
Stall Torque	5.6 in-oz. @ 150 psi (per squareinch)	6.7 in-oz. @ 150 psi (per square inch)
Maximum OperatingPressure	120 psi (per square inch)	Up to 150 psi (per square inch)
Grip Design	Smooth	Knurled
Router RetentionMechanism	Friction	Spring Collar
Method of Sterilization	Moist Heat (Steam)	Moist Heat (Steam)
Sterility Assurance Level(SAL)	10-e	10-e
Method of Packaging	Packaged in a polybag caseconfiguration	Packaged in a sealed air Korrvuretention Insert configuration

Image /page/5/Picture/5 description: The image shows the text "510(k) Summary". The text is in a simple, sans-serif font and is left-aligned. The background is plain white, providing a clean and clear presentation of the text.

stryker

STRYKER® MAESTRO AIR™ MOTORS

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

Image /page/6/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 word.

Table 6-1: Summary of Predicate Comparison (Continued)
--------------------------------------------------------	--	--	--

DESCRIPTION	STRYKER MAESTRO PNEUMATICSYSTEM [PREDICATE]K041754	STRYKER® MAESTRO AIR™ MOTORS[SUBJECT]
Cleaning Method	Manual	Manual and Mechanical (automated)
Weight of the Motor andHose	2.05 lb.	1.65 lb.
Housing Material	Stainless Steel	Stainless Steel and Aluminum
Pneumatic HoseAssembly	Exhaust Hose: FlurosiliconeInlet Hose: Nitrile rubber	Exhaust Hose: Flurosilicone withsilicone jacket and Slick Sil coatingInlet Hose: Nitrile rubber andneoprene

Conclusion/Substantial Equivalence Rationale

The Stryker Maestro Air Motors is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the previously cleared Stryker Maestro Pneumatic System. 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 Maestro Air Motors is substantially equivalent to the existing predicate device.

Page 4 of 4

STRYKER® MAESTRO AIR™ MOTORS

Regulation Number and Section

§ 882.4370 Pneumatic cranial drill motor.

(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).