The Mako System is intended to assist the surgeon in providing software spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy.

These procedures include:

· Total Knee Arthroplasty (TKA)
The implants systems compatible with this system:
· Triathlon Total Knee System (CR/CS/PS cemented Primary)
· Kinetis Total Knee System (CR/UC)

Device Description

The Mako System with the Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

The Mako robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Mako Total Knee Application, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses primarily on verifying the integration of a new online portal (eRequest LifeCycle) into an existing device (Mako Total Knee Application, cleared via K143752). Therefore, the acceptance criteria are related to the successful functionality and integration of this change, rather than new performance criteria for the core surgical application itself.

Acceptance Criteria (Purpose)	Reported Device Performance (Validation/Verification Results)
Verify that TKA fields and values implemented into the eRequest application must match the TKA Product Specifications.	Pass
Verify the integration of the eRequest Lifecycle into the Mako System provides adequate functionality to successfully complete the pre-operative planning workflow.	Pass
Validate in a simulated-use environment, with appropriate user, that the implementation of eRequest LifeCycle into the Mako System provides adequate functionality to successfully complete the pre-operative workflow and satisfies the customer requirements.	Pass

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

The document does not explicitly state a specific numerical "sample size" in terms of cases or patients for the test set. The validation appears to be functional and simulated-use testing.

Test Set Sample Size: Not explicitly stated as a number of cases/patients. The testing involved verifying product specifications and running through the eRequest system in a "simulated-use environment" with an "appropriate user."
Data Provenance: Not applicable in the context of clinical data for this type of submission. The testing is for the integration and functionality of a software component (eRequest Lifecycle) within an existing device, not for clinical performance on patient data.

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

This information is not provided in the document. The "ground truth" for these tests relates to the proper functioning of the software and its adherence to product specifications and user requirements, not clinical diagnoses or outcomes adjudicated by medical experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the testing (product specification verification and functional run-throughs), a formal adjudication method by multiple experts is unlikely to have been employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission focuses on a modification (integration of eRequest LifeCycle) to an existing cleared device (Mako Total Knee Application K143752). The studies are functional and simulated-use tests for this integration, not clinical comparative effectiveness studies showing human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study was not done. The Mako System, by definition, is designed to "assist the surgeon" and serves as a "surgeon's 'intelligent' tool holder or tool guide." Its primary function involves human interaction for pre-surgical planning, implant placement, and intraoperative navigation. The software (eRequest LifeCycle) is part of the pre-operative planning workflow that supports the human surgeon.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the verification and validation tests in this submission appears to be:

Product Specifications: For the "Product Specification Verification" test.
Intended Functionality/Workflow Success: For the "eRequest – Full System Run Through" and "Planning Workflow - TKA Validation" tests, ensuring the system performs as designed and meets user/customer requirements in a simulated environment.

8. Sample Size for the Training Set

This information is not applicable and not provided. The submission is for a modification to an existing device, involving the integration of a new online portal (eRequest LifeCycle) for case management and file transfer. This is not an artificial intelligence/machine learning model where a "training set" of data would be used to develop an algorithm.

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

This information is not applicable and not provided, as there is no mention of a training set for an AI/ML algorithm in this submission.

Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

May 11, 2017

MAKO Surgical Corp. Shikha Khandelwal Staff Regulatory Affairs Specialist 2555 Davie Rd Fort Lauderdale, Florida 33317

Re: K170581

Trade/Device Name: Mako Total Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 27, 2017 Received: February 28, 2017

Dear Shikha Khandelwal:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

the quality systems (OS) 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" (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 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K170581

Device Name

Mako Total Knee Application

Indications for Use (Describe)

Indications for Use:

The Mako System is intended to assist the surgeon in providing software spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

These procedures include:

· Total Knee Arthroplasty (TKA)
The implants systems compatible with this system:
· Triathlon Total Knee System (CR/CS/PS cemented Primary)
· Kinetis Total Knee System (CR/UC)

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."

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

Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in a bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font below. Above the word "MAKO" is a blue, curved shape that resembles a wave or fin. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.

1555 Davie Road • Ft. Lauderdale, FL 3331 hone 954.927.2044 • Fax 954.927.04 ww.makosurgical.com

510(K) SUMMARY

Sponsor:	MAKO Surgical Corp.2555 Davie Road, Fort Lauderdale, FL 33317
Contact Person:	Shikha Khandelwal, PhDShikha.khandelwal@stryker.comPhone: 201-831-6921Fax: 201-831-3921
Date Prepared:	February 24, 2017
Proprietary Name:	Mako Total Knee Application
Common Name:	Total Knee Application (TKA)
Regulation Name:	Stereotaxic Instrument
Regulation Number:	21 CFR 882.4560
Device Classification:	Class II
Product Code:	OLO

Substantial Equivalence Claimed To:

The Mako Total Knee Application is substantially equivalent to the Mako Total Knee Application cleared via K143752.

Device Modification: An alternate online portal for case management and file transfer known as eRequest LifeCycle is being implemented for use during the preoperative planning workflow of the Mako Total Knee application.

Description:

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

Summary of Technological Characteristics Compared to Predicate Devices: The technological characteristics of the Mako Total Knee Application compared to the predicate device are listed below:

TechnologicalCharacteristics	Mako Total Knee Application	Mako Total Knee Application(K143752)
MajorComponents	Guidance Module, robotic arm,camera stand, cutting system,preoperative planning laptop.	Guidance Module, robotic arm,camera stand, cutting system,preoperative planning laptop.
Tools/accessories	Various reusable and disposableinstruments	Various reusable and disposableinstruments
Image Use	CT	CT

Intended Use/Indications for Use:

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

. Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
. Triathlon Total Knee System (CR/CS/PS cemented Primary)
Kinetis Total Knee System (CR/UC)

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

Performance Data:

Validation / VerificationMethod	Purpose	Validation / VerificationResults
Product SpecificationVerification	Verify that TKA fields andvalues implemented intothe eRequest applicationmust match the TKAProduct Specifications.	Pass
eRequest – Full SystemRun Through for TKAApplication	Verify the integration ofthe eRequest Lifecycleinto the Mako Systemprovides adequatefunctionality tosuccessfully complete thepre-operative planningworkflow	Pass
Planning Workflow - TKAValidation	Validate in a simulated-use environment, withappropriate user, that theimplementation ofeRequest LifeCycle intothe Mako System providesadequate functionality tosuccessfully complete thepre-operative workflowand satisfies the customerrequirements.	Pass

Conclusions of Performance Testing:

Performance testing has demonstrated that the characteristics of the Mako Total Knee Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness, and therefore, supports a determination of Substantial Equivalence.

Image /page/5/Picture/4 description: The image shows a light blue abstract shape against a white background. The shape is curved and pointed at both ends, with a notch in the middle of the top edge. The shape resembles a stylized wing or a swooping curve. The overall impression is simple and minimalist.

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).