The Partial Knee Application (PKA), for use with the Mako System, is intended to assist the surgeon in providing software defined spatial boundaries for orientation to anatomical structures during orthopedic procedures.

The Partial Knee Application (PKA), for use with 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 unicondylar knee replacement and/or patellofemoral knee replacement.

Device Description

The Mako System with the Partial 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

Based on the provided text, the Mako Partial Knee Application is a Class II medical device, product code OLO, regulated under 21 CFR 882.4560 (Stereotaxic Instrument). This device is intended to assist surgeons by providing software-defined spatial boundaries for orientation and reference to anatomical structures during orthopedic procedures, specifically unicondylar knee replacement and/or patellofemoral knee replacement. The 510(k) submission (K170584) claims substantial equivalence to the predicate device, Mako Partial Knee Application cleared via K112507.

The primary change described is the implementation of an alternate online portal for case management and file transfer, known as eRequest LifeCycle, for use during the preoperative planning phase. The performance data focuses on verifying and validating this new component's functionality and integration into the existing Mako System.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Purpose of Test)	Reported Device Performance (Validation/Verification Results)
Product Specification Verification: Verify that PKA fields and values implemented into the eRequest application must match the THA Product Specifications.	Pass
eRequest - Full System Run Through for PKA Application: Verify the integration of the eRequest LifeCycle into the Mako System provides adequate functionality to successfully complete the pre-operative planning workflow.	Pass
eRequest LifeCycle PKA Validation: 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 the sample size (e.g., number of cases or simulations) used for each test. The studies appear to be focused on the new eRequest LifeCycle portal and its integration. The data provenance is also not specified; it is implied to be internal testing by the manufacturer rather than retrospective or prospective clinical data from external sources.

3. Number of Experts and their Qualifications for Ground Truth

The document mentions "appropriate user" for the eRequest LifeCycle PKA Validation but does not specify the number or qualifications of experts (e.g., radiologists, orthopedic surgeons) used to establish ground truth or validate the functionality. This type of testing appears to be functional validation rather than diagnostic performance assessment requiring expert review.

4. Adjudication Method for the Test Set

No details regarding an adjudication method (e.g., 2+1, 3+1) are present. Given the nature of the tests ("Pass" outcomes for functional verification/validation), human adjudication of complex diagnostic interpretations is not indicated.

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

No MRMC comparative effectiveness study was mentioned. The submission focuses on the substantial equivalence of an updated component (eRequest LifeCycle portal) rather than demonstrating an improvement in human reader performance with or without AI assistance. This device is an orthopedic surgical robotic system, not an AI-powered diagnostic imaging tool that would typically involve MRMC studies for reader performance.

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

While the device itself is a "stereotaxic instrument" with a "robotic arm" and "operating software," the performance data presented pertains specifically to the eRequest LifeCycle portal. The tests described are functional verification and validation of this portal's integration and workflow capability. There is no mention of a standalone algorithm performance study in the context of diagnostic accuracy, which would be typical for AI-based image analysis algorithms. The "standalone" performance here relates to the technical functioning of the software component.

7. Type of Ground Truth Used

The "ground truth" for these tests appears to be defined by the "THA Product Specifications" (for Product Specification Verification) and the "pre-operative planning workflow" and "customer requirements" (for eRequest - Full System Run Through and eRequest LifeCycle PKA Validation). This means the ground truth is established by design specifications and user requirements, not clinical outcomes, pathology, or expert consensus on patient data.

8. Sample Size for the Training Set

This information is not applicable and not provided. The described changes are related to a software portal for case management and file transfer, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for image analysis or prediction tasks. The "training" here relates to software development and testing, where test cases would be used, but not in the context of a machine learning training set for learning from data.

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

As above, this information is not applicable. The "ground truth" for the functional tests was internal product specifications and defined workflow requirements, not clinical data requiring expert annotation or similar for machine learning purposes.

Summary

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

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

May 11, 2017

Re: K170584

Trade/Device Name: Mako Partial 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 device

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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/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

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Indications for Use

510(k) Number (if known)

K170584

Device Name

Partial Knee Application

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below "MAKO" is the text "SURGICAL CORP" in smaller, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or an arc.

55 Davie Road · Ft. Lauderdale, FL 3 2044 · Fax 954.927.0 ww.makosuraical.com

510(K) SUMMARY

Sponsor:	MAKO Surgical Corp.2555 Davie RoadFort Lauderdale, FL 33317
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Contact Person:

Shikha Khandelwal, PhD Shikha.khandelwal@stryker.com Phone: 201-831-6921 Fax: 201-831-3921

Date Prepared: February 24, 2017

Proprietary Name: Mako Partial Knee Application

Common Name: Partial Knee Application (PKA)

Regulation Name: Stereotaxic Instrument

Regulation Number: 21 CFR 882.4560

Device Classification: Class II

Product Code: OLO

Substantial Equivalence Claimed To:

The Mako Partial Knee Application is substantially equivalent to Mako Surgical's Partial Knee Application cleared via K112507.

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 phase of the Mako Partial Knee Application.

Description:

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

TechnologicalCharacteristics	Mako Partial Knee Application	Mako Partial Knee Application(K112507)
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 Partial Knee Application (PKA), for use with 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.

Performance Data:

Validation / VerificationMethod	Purpose	Validation / VerificationResults
Product SpecificationVerification	Verify that PKA fields andvalues implemented intothe eRequest applicationmust match the THAProduct Specifications.	Pass
eRequest - Full System	Verify the integration of	Pass

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Run Through for PKAApplication	the eRequest Lifecycleinto the Mako Systemprovides adequatefunctionality tosuccessfully complete thepre-operative planningworkflow
eRequest LifeCycle PKAValidation	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 Partial 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/3 description: The image shows a light blue, abstract shape against a white background. The shape is curved and tapers at both ends, resembling a stylized wing or a swooping arc. The color is a soft, pastel blue, and the overall impression is minimalist and clean.

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).