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)

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 Make System is indicated for use in surgical knee and hip 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
· Total Hip Arthroplasty (THA)

Device Description

The Mako System with the subject Total Hip 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.

Once configured for a specific application, the Mako robotic-arm 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.

The Mako System with the subject 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.

AI/ML Overview

The provided text describes the regulatory clearance for the Mako Total Hip Application and Mako Total Knee Application, but it does not contain information about acceptance criteria or specific study details proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results with acceptance criteria.

Specifically, it mentions:

Non-clinical performance testing: "Software testing", "Treatment Design Application Full Software Run Through", "Bone Registration Accuracy Verification", and "Mako Total Hip/Knee Application Full System Run Through".
Conclusion: "Performance testing has demonstrated that the characteristics of the subject Mako Total Hip/Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness."

However, it does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set or data provenance.
Number of experts, their qualifications, or ground truth establishment details for the test set.
Adjudication methods.
MRMC study information.
Standalone performance details.
Type of ground truth used.
Training set sample size.
How ground truth for the training set was established.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the level of detail requested as this information is not present in the document. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than detailing the full performance study methodology and results.

The document only states that "Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application/Mako Total Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness." It mentions non-clinical performance testing including:

Treatment Design Application Full Software Run Through
Bone Registration Accuracy Verification
Mako Total Hip/Knee Application Full System Run Through

However, it does not provide any specific quantitative acceptance criteria, the results against these criteria, or the detailed methodologies (like sample size, type of ground truth, expert qualifications, etc.) of these performance tests.

To answer your request, the following information is missing from the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document states performance testing was done and concluded equivalence and safety/effectiveness, but no specific metrics or targets are given.
Sample sizes used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 for this type of device, which is a surgical robotic system for guidance, not an AI-assisted diagnostic tool for human readers. No MRMC study details are provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document refers to "non-clinical performance testing" including software run-throughs and accuracy verification, which might be considered standalone testing of system components, but it doesn't provide details on what constitutes "standalone performance" in this context or its results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. The testing relates to "Bone Registration Accuracy Verification," implying an objective measurement against a known standard, but the specific ground truth methodology is not detailed.
The sample size for the training set: Not applicable based on the nature of the device (surgical guidance system, not a machine learning model requiring a separate training set for algorithm development described here). If it were a machine learning algorithm, this would be highly relevant, but the description points to verifying the performance of a software tool that processes CT data for surgical planning and guidance.
How the ground truth for the training set was established: Not applicable for the same reason as point 8.

Summary

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September 24, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

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

Re: K191998

Trade/Device Name: Mako Total Hip Application, Mako Total Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 23, 2019 Received: July 26, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure List of Cleared Devices in K191998

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List of Cleared Devices in K191998

Mako Total Hip Application
Mako Total Knee Application

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191998

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)

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."

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191998

Device Name

Mako Total Hip Application

Indications for Use (Describe)

· Unicondylar knee replacement and/or patellofemoral knee replacement
· Total Hip Arthroplasty (THA)

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.

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."

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Image /page/5/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word "MAKO" is a blue, stylized arc that resembles a shark fin or a wave. The logo is clean and modern, with a focus on the company name and a simple, memorable graphic element.

555 Davie Road · Ft. Lauderdale, FL 33317 27.2044 • Fax 954.927.0446 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: 201-831-6921
Date Prepared:	July 23, 2019
Proprietary Name:	Mako Total Hip Application
Common Name:	Total Hip Application (THA)
Regulation Name:	Stereotaxic Instrument
Regulation Number:	21 CFR Section 882.4560
Device Classification:	Class II
Product Code:	OLO

Substantial Equivalence Claimed To:

The subject device, the Mako Total Hip Application, is substantially equivalent to the predicate device, the Mako Total Hip Application, cleared via K170593.

Device Modification:

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

Pre-operative Planning Process Treatment Design Application (TDA) is a ● new software tool which will be implemented into the pre-operative planning process of Mako Total Hip procedures.
The software tool is intended to accept CT imaging data and process it to generate the patient-specific 3D models and anatomic landmarks utilized for pre-operative implant planning.

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Description:

Summary of Technological Characteristics Compared to Predicate Devices:

the predicate device are listed below:
TechnologicalCharacteristics	Mako Total Hip Application	Mako Total Hip Application – K170593
Major Components	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 anddisposable instruments	Various reusable and disposable instruments
Image Use	CT	CT

The technological characteristics of the Mako Total Hip Application compared to the predicate device are listed helow

Intended Use - The subject device has the same intended use as that specified in the cleared 510(k) premarket notification for the predicate device.

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.

The Mako System is indicated for use in surgical knee and hip 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:

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Unicondylar knee replacement and/or patellofemoral knee replacement
. Total Hip Arthroplasty (THA)

Performance Data – The modified Mako System with the Mako Total Hip Application has been evaluated through the following non-clinical performance testing:

Software testing: .
- o Treatment Design Application Full Software Run Through
- o Bone Registration Accuracy Verification
- o Mako Total Hip Application Full System Run Through

Conclusions of Performance Testing:

Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing supports a determination of Substantial Equivalence.

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Image /page/8/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo consists of the word "MAKO" in large, bold, black letters, with the words "SURGICAL CORP" in smaller, black letters underneath. Above the word "MAKO" is a blue, curved shape that resembles a wave or an abstract mountain range.

555 Davie Road · Ft. Lauderdale, FL 33317 .2044 · Fax 954.927.0446 akosurgical.com

510(k) SUMMARY

Sponsor:	Mako Surgical Corp.2555 Davie Road,Fort Lauderdale, FL 33317
Contact Person:	Shikha Khandelwal, PhDshikha.khandelwal@stryker.comPhone: 201-831-6921
Date Prepared:	July 23, 2019
Proprietary Name:	Mako Total Knee Application
Common Name:	Total Knee Application (TKA)
Regulation Name:	Stereotaxic Instrument
Regulation Number:	21 CFR Section 882.4560
Device Classification:	Class II
Product Code:	OLO

Substantial Equivalence Claimed To:

The subject device, the Mako Total Knee Application, is substantially equivalent to the predicate device, Mako Total Knee Application, cleared via K172219.

Device Modification:

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

Pre-operative Planning Process Treatment Design Application (TDA) is a ● new software tool which will be implemented into the pre-operative planning process of Mako Total Knee procedures.
The software tool is intended to accept CT imaging data and process it to generate the patient-specific 3D models and anatomic landmarks utilized for pre-operative implant planning.

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Description:

Summary of Technological Characteristics Compared to Predicate Devices:

TechnologicalCharacteristics	Mako Total Knee Application	Mako Total Knee Application – K172219
Major Components	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 anddisposable instruments	Various reusable and disposable instruments
Image Use	CT	CT

The technological characteristics of the Mako Total Knee Application compared to the predicate device are listed below:

Intended Use - The subject device has the same intended use as that specified in the cleared 510(k) premarket notification for the predicate device.

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.

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. 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)

Performance Data – The modified Mako System with the Mako Total Knee Application has been evaluated through the following non-clinical performance testing:

. Software testing:
- o Treatment Design Application Full Software Run Through
- o Bone Registration Accuracy Verification
- o Mako Total Knee Application Full System Run Through

Conclusions of Performance Testing:

Performance testing has demonstrated that the characteristics of the subject Mako Total Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing 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).