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.

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 implant systems compatible with the system:

· Triathlon Total Knee System (CR/CS/PS cemented and cementless primary)
· Triathlon Total Knee System (TS inserts 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/haptic 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

The provided text focuses on the FDA's 510(k) clearance for the Mako Total Knee Application (K172219), stating its substantial equivalence to a predicate device (K170581). This document does not contain the detailed acceptance criteria or the specific results of a study that proves the device meets those criteria in the format typically used for AI/ML device performance evaluation (e.g., sensitivity, specificity, or clinical outcome measures, MRMC studies, etc.). Instead, it describes performance testing in the context of a robotics-assisted surgical system.

However, based on the information provided, we can infer some aspects and construct a response within the given limitations.

Here's an attempt to answer your questions based only on the provided text, highlighting what information is not available:

Acceptance Criteria and Device Performance for MAKO Total Knee Application (K172219)

The provided document describes a 510(k) submission for the MAKO Total Knee Application. Unlike AI/ML medical devices that often have specific performance metrics like sensitivity and specificity measured against a ground truth, this device is a surgical assistance system (stereotaxic instrument). Its "performance" revolves around its ability to provide accurate spatial guidance and integrate with specific implants, demonstrating substantial equivalence to a previously cleared device.

Since the document is a 510(k) clearance letter and summary, it primarily focuses on establishing "substantial equivalence" to a predicate device, rather than detailing a study with explicit quantitative acceptance criteria for each specific metric typically seen in AI/ML validation.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a table with explicit numerical acceptance criteria for statistical metrics (like sensitivity/specificity for diagnostic AI) or detailed performance results in that format. Instead, the performance evaluations mentioned are designed to demonstrate the system's accuracy and functionality for its intended surgical guidance purpose. The "acceptance" is implicitly tied to demonstrating functionality and accuracy comparable to the predicate device.

Category	Acceptance Criteria (Inferred from document)	Reported Device Performance (Inferred from document)
Functional Accuracy	The system must accurately provide software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. This includes accurate pre-surgical planning, implant placement, and interpretive/intraoperative navigation. (Implied: comparable to predicate device performance).	"Cutting Accuracy Verification" was performed. "Full system Cadaver Validation" was performed. The "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..."
Safety	The device must not raise different questions of safety or effectiveness compared to the predicate device.	"Performance testing has demonstrated... 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."
Compatibility	The system must be compatible with the specified implant systems (e.g., Triathlon Total Knee System, Kinetis Total Knee System).	The device is explicitly stated to be compatible with: Triathlon Total Knee System (CR/CS/PS cemented and cementless primary), Triathlon Total Knee System (TS inserts cemented primary), and Kinetis Total Knee System (CR/UC). (This was a specific modification addressed in this 510(k) via compatible implants and labeling updates).

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

Sample Size: The document mentions "Cutting Accuracy Verification" and "Full system Cadaver Validation." The specific number of cases or cadavers used for these tests is NOT provided.
Data Provenance: The document does not specify the country of origin. The validation involved "Cadaver Validation," implying a laboratory or simulated surgical environment. The studies are non-clinical performance testing. It does not state whether it was retrospective or prospective in a clinical setting, as it's a non-clinical, pre-market submission.

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

Not Applicable / Not Provided. For a surgical robotic system's "accuracy" and "functional performance," the ground truth is often established by engineering specifications, physical measurements, and comparison against established surgical methodologies or predicate device performance, rather than expert human interpretation of images like in diagnostic AI. The document does not refer to "experts" establishing a ground truth in the context of image labeling or diagnosis.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are interpreting data (like medical images) and their interpretations need to be reconciled to form a ground truth. This type of method is not mentioned for the non-clinical performance testing of a surgical robot.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic or AI-assisted diagnostic devices where the performance of human readers (with and without AI assistance) is compared. This document describes a surgical robotic system for guiding procedures. The type of testing performed (Cutting Accuracy, Cadaver Validation) is not an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Partially Applicable, but not in the typical AI sense. The system works as a "surgeon's intelligent tool holder or tool guide." The "Cutting Accuracy Verification" would be a standalone test of the system's precision based on its programming and mechanics. However, its ultimate function is always "human-in-the-loop" as it assists a surgeon. The term "algorithm only" is less fitting for a hardware-software integrated robotic system where the algorithm drives the physical guidance. The non-clinical tests would evaluate the system's mechanical and computational accuracy.

7. The Type of Ground Truth Used

Engineering Specifications / Physical Measurement / Pre-defined Anatomical Models. For "Cutting Accuracy Verification," the ground truth would be based on precise measurement of cuts against intended/programmed cuts or anatomical landmarks. For "Cadaver Validation," the ground truth would relate to the successful and accurate completion of surgical steps (e.g., implant alignment, bone preparation) as determined by established surgical principles and post-procedure measurements on the cadaver. It is based on CT-based models of anatomy which the system uses for reference.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This device is a stereotaxic instrument that uses pre-operative CT data for planning and intraoperative guidance, not a machine learning algorithm that is "trained" on a large dataset of patient images in the way many AI/ML diagnostic tools are. Its "training" is in its engineering design and calibration.

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

Not Applicable. As noted above, this device does not have a "training set" in the common machine learning sense. Its "knowledge" is embedded in its design, calibration, and the anatomical information derived from patient-specific CT scans.

Summary

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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is likely for a specific department or office within the FDA.

MAKO Surgical Corp. Karen Ariemma Senior Manager Regulatory Affairs 2555 Davie Road Fort Lauderdale, Florida 33317

September 21, 2017

Re: K172219

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: July 21, 2017 Received: July 24, 2017

Dear Karen Ariemma:

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 (DICE) 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 (DICE) 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

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

510(k) Number (if known)

K172219

Device Name Mako Total Knee Application

Indications for Use (Describe)

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 and cementless primary)
· Triathlon Total Knee System (TS inserts 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)

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Image /page/3/Picture/1 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 stylized shark fin or wave.

555 Davie Road • Ft. Lauderdale, FL 27.2044 • Fax 954.927.0 ww.makosurgical.com

510(k) SUMMARY

Sponsor:	Mako Surgical Corp.2555 Davie Road, Fort Lauderdale, FL 33317
Contact Person:	Karen Ariemmakaren.ariemma@stryker.comPhone: 201-831-5718
Date Prepared:	July 21, 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 K170581.

Device Modification:

The following changes have been made to the Mako Total Knee Application:

. Compatible implants - Addition of the Triathlon cementless components (CR and PS femoral components, tibial baseplates and patellar components), Triathlon All Poly tibial components and Triathlon TS inserts.
. Labeling - Implant compatibility has been modified in the Indications for Use.

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

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computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

TechnologicalCharacteristics	Mako Total Knee Application	Mako Total Knee Application(K170581)
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 disposable instruments	Various reusable and disposable instruments
Image Use	CT	CT

Summary of Technological Characteristics Compared to Predicate Devices: The technological characteristics of the Mako Total Knee Application compared to

Intended Use/Indications for Use:

the predicate device are listed below:

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 and cementless primary) ●
Triathlon Total Knee System (TS inserts cemented primary) .
Kinetis Total Knee System (CR/UC) ●

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Performance Data - The Mako System has been evaluated through the following non-clinical performance testing:

Cutting Accuracy Verification ●
Full system Cadaver Validation .

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.

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).