The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The RIO 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

MAKOplasty Total Hip Application is an upgrade to RIO-THA (K093425). The features of this application are to improve overall performance of the system in supporting total hip arthroplasty. MAKOplasty Total Hip Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.

The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: hip procedures and knee procedures (per K112507). With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.

RIO's 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

This document describes the MAKOplasty Total Hip Application, an upgrade to the RIO-THA (Total Hip Arthroplasty) system. This device is intended to assist surgeons by providing software-defined spatial boundaries and real-time guidance during orthopedic procedures, specifically total hip arthroplasty, unicondylar knee replacement, and patellofemoral knee replacement. It uses patient CT data for pre-surgical planning and intraoperative navigation.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "All testing Passed" for the verification activities and "Passed" for validation testing. The main performance characteristic is the device's ability to "support total hip arthroplasty procedures, and unicondylar and/or patellofemoral knee replacement" and a "System Accuracy" test. No specific quantitative metrics for accuracy (e.g., target deviation in mm) or other performance parameters are provided in the excerpt.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Total Hip Application Full Cadaver Validation Lab" for validation testing. However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). Cadaver labs are typically prospective and aim to simulate real-world surgical conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The nature of the "Full Cadaver Validation Lab" suggests surgical experts would be involved in assessing the outcomes, but their number and qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for the test set in the validation lab.

5. 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

The document does not mention an MRMC comparative effectiveness study involving human readers or an AI assistance component. The device itself is an assistive robotic system for surgical procedures, not an AI diagnostic tool primarily for human reader interpretation. No effect size for human reader improvement is provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document describes the device as a "Robotic Arm Interactive Orthopedic System (RIO)" intended to "assist the surgeon" and serve as a "surgeon's 'intelligent' tool holder or tool guide." This indicates a human-in-the-loop system, not a standalone algorithm without human involvement. Therefore, a standalone performance study as typically understood for diagnostic AI was likely not performed or relevant in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Total Hip Application Full Cadaver Validation Lab," the ground truth would likely be based on objective measurements of implant placement, alignment, and other surgical parameters post-procedure, measured against pre-operative plans. This would involve expert assessment and direct measurement within the cadaveric setting, rather than pathology or long-term outcomes data. The document does not explicitly state the specific methods used to establish this ground truth.

8. The sample size for the training set

The document does not provide information about a "training set" or its sample size. This device is an upgrade to an existing robotic surgical system, and the information presented focuses on the verification and validation of the application itself, not on the training of an AI model in the conventional sense.

9. How the ground truth for the training set was established

As no training set is mentioned for an AI model, this information is not applicable. The device's functionality is based on pre-programmed designs and real-time navigation guided by CT data, rather than machine learning trained on large datasets.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic element that resembles an arrow or a stylized letter "A". At the top of the image is the number "K121064".

t lauderdale, florida 33317

JUN - 6 2012 page i of 2

2555 davie road

tal 954,927

fax 954.927.0446

510(K) SUMMARY

Submitter: Address: Phone number: Fax number: Contact Person: Date Prepared: Device Trade Name: Regulation Name: Regulation Number: Device Classification: Product Code:

MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL 33317 954-628-0655 954-927-0446 Dionne Sanders April 4, 2012 MAKOplasty Total Hip Application . Stereotaxic Instrument 21 CFR 882.4560 Class II OLO

Substantial Equivalence Claimed To: MAKOplasty Total Hip Application is substantially equivalent to MAKO Surgical's (Robotic Arm Interactive Orthopedic System) RIO - (Total Hip Arthroplasty) THA cleared via K093425.

Description: MAKOplasty Total Hip Application is an upgrade to RIO-THA (K093425). The features of this application are to improve overall performance of the system in supporting total hip arthroplasty. MAKOplasty Total Hip Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.

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

Image /page/1/Picture/0 description: This image contains the logo for MAKO Surgical Corp. The image also contains the text 'K121064' at the top, and 'Page 7 of 2' on the right side. At the bottom of the image, the address '2555 davie road fort lauderdale, florida 33317' is printed, along with the phone number 'tel 954.927.2044' and fax number 'fax 954.927.0446'.

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

TechnologicalCharacteristics	MAKOplasty Total HipApplication	RIO-THA(K093425)
MajorComponents	Guidance Module, robotic arm, camera stand, drill system, preoperative planning laptop.	Guidance Module, robotic arm, camera stand, drill system, preoperative planning laptop.
Tools/accessories	Various reusable instruments	Various reusable instruments
Images Use	CT	CT

Performance Data: Unit, Integration and System level testing was performed with the MAKOplasty Total Hip Application with the knee software dually installed in order to evaluate the application's ability to support total hip arthroplasty procedures, and unicondylar and/or patellofemoral knee replacement. A summary of the completed design verification and validation activities to support substantial equivalence is as follows:

Verification Testing - All testing Passed

Partial Knee Application Verification ●
. System Accuracy
Full Application Software Runthrough .

Validation Testing- Passed

. Total Hip Application Full Cadaver Validation Lab

Intended Use/Indications for Use

Unicondylar knee replacement and/or patellofemoral knee replacement o
Total hip arthroplasty (THA) 0

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure with three arms or lines extending upwards, symbolizing health, services, and humanity. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

Public Health Service

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

JUN - 6 2012

Mako Surgical Corporation c/o Ms. Dionne Sanders Senior Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317

Re: K121064

Trade/Device Name: Makoplasty Total Hip Application, RIO Standard System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 8, 2012 Received: May 11, 2012

Dear Ms. Dionne Sanders:

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 10 too barranor 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.

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

Page 2 - Ms. Sanders

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

for

Nop

Mark N. Melk rson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the logo is a black graphic that resembles an abstract shape. At the top of the image, there is a handwritten text "K121064".

fort lauderdale, florida 33317

tel 954.927.2044

fax 954.927.0446

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: MAKOplasty Total Hip Application

Indications for Use:

Unicondylar knee replacement and/or patellofemoral knee replacement ಂ

. Total hip arthroplasty (THA) o

Prescription Use X OR

Over-the-Counter Use

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121064

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).