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/PSR 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 subject Mako 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 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 the 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 document is a 510(k) summary for the Mako Total Knee Application, which describes modifications to an existing device. It discusses the device's intended use and technical characteristics compared to a predicate device, as well as performance testing conducted. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in your prompt regarding dataset details, expert qualifications, and comparison to human performance with AI assistance.

Therefore, I cannot populate the requested table and answer many of your specific questions based solely on the provided text. The document states that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device," but it does not provide the specific metrics or acceptance criteria used to make this determination, nor does it present the detailed results from the "Simulated-use cadaveric surgeon validation" or "Knee alignment clinical outcomes data review."

Below is a table where I have filled in what little information is directly available and indicated where requested information is not present in the provided text.

Acceptance Criteria and Device Performance Study Details for Mako Total Knee Application (K193515)

Category	Information from Document
1. Acceptance Criteria and Reported Device Performance	Acceptance Criteria: Not explicitly stated in the provided document. The document refers to demonstrating equivalence to a predicate device and states that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device." However, the specific quantitative acceptance criteria for this equivalence are not provided.
	Reported Device Performance: Not explicitly detailed with quantitative metrics in the provided document. The document states that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device" and that the device is "as safe and as effective as the predicate device." Specific measured performance metrics are not given.
2. Sample Size (Test Set) & Data Provenance	The document mentions "Simulated-use cadaveric surgeon validation" and "Knee alignment clinical outcomes data review" as performance testing. However, the sample size for the test set (number of cadavers or cases) is not specified. The data provenance (e.g., country of origin, retrospective/prospective) is not specified.
3. Number & Qualifications of Experts (Ground Truth)	Not specified in the provided document. The "Simulated-use cadaveric surgeon validation" implies involvement of surgeons, but their number, qualifications, or their role in establishing ground truth (vs. performing the validation) are not detailed. An "Mako TKA User Guides" is mentioned for labeling.
4. Adjudication Method (Test Set)	Not specified in the provided document.
5. MRMC Comparative Effectiveness Study & Effect Size	No multi-reader multi-case (MRMC) comparative effectiveness study explicitly mentioned, nor is an effect size for human readers with/without AI assistance provided. The device is a stereotactic instrument with a robotic arm, providing haptic guidance and assisting surgeon with pre-surgical planning and intraoperative navigation. It's a tool for the surgeon, rather than an AI-driven diagnostic aid that improves human interpretation directly in a traditional MRMC sense.
6. Standalone (Algorithm Only) Performance Study	Not explicitly mentioned as a standalone performance study. The device's description focuses on its function with a surgeon ("assist the surgeon," "serve as the surgeon's 'intelligent' tool holder or tool guide").
7. Type of Ground Truth Used	Not explicitly specified. Given the context of "Simulated-use cadaveric surgeon validation" and "Knee alignment clinical outcomes data review," the ground truth would likely relate to anatomical accuracy, implant positioning accuracy, or surgical outcome measures, but the precise definition of "ground truth" (e.g., highly accurate imaging, post-surgical assessment, expert consensus on optimal placement) is not detailed.
8. Sample Size (Training Set)	Not specified in the provided document. The document doesn't explicitly discuss an AI model being 'trained' in the conventional sense, but rather a system that uses CT data and provides haptic guidance.
9. How Ground Truth for Training Set Was Established	Not specified in the provided document. There's no mention of a traditional 'training set' or how its ground truth would have been established. The system uses "patient CT data" for planning, which implies the CT data itself serves as the basis for the anatomical model rather than a 'ground truth' that needs to be established for learning.

Summary

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July 14, 2020

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

Re: K193515

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 13, 2020 Received: July 14, 2020

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

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Indications for Use

510(k) Number (if known) K193515

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/PSR 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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K193515

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 wave or arc.

Road • Ft. Lauderdale, FL 3331 044 • Fax 954.927.0446 surgical.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 14, 2020

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 K191998.

In addition, the alignment methods and alignment limits for the subject Mako Total Knee Application are substantially equivalent to those of the reference device, the Triathlon Total Knee System, cleared via K201343.

Device Modification:

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

Indications for Use – Addition of the Triathlon PSR tibial inserts as compatible for use with the Mako Total Knee Application.
Labeling (Mako TKA User Guides) ●

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o Addition of the Triathlon PSR tibial inserts as compatible for use with the Mako Total Knee Application.
Addition of an individualized alignment pre-operative planning o methodology for Mako Total Knee Application-compatible Triathlon Total Knee System components when placed with the Mako System.

Description:

Summary of Technological Characteristics Compared to Predicate Device:

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 –K191998
Major Components	Guidance Module, robotic arm,camera stand, cutting system,preoperative planning laptop.	Guidance Module, robotic arm, camerastand, cutting system, preoperativeplanning laptop.
Tools/accessories	Various reusable and disposableinstruments	Various reusable and disposableinstruments
Image Use	CT	CT

Intended Use

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

Indications for Use: Mako Total Knee Application

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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 mav 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/PSR 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 subject Mako Total Knee Application has been evaluated through the following non-clinical performance testing:

Simulated-use cadaveric surgeon validation ●
. Knee alignment clinical outcomes data review

Conclusions:

The hardware and software of the subject Mako System with Mako Total Knee Application is identical to the hardware and software of the predicate Mako System with Mako Total Knee Application. The addition of compatibility with the Triathlon PSR tibial inserts and an individualized alignment pre-operative plan option in the labeling does not impact the intended use or the fundamental technology of the device. Furthermore, performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device. The subject 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).