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 o
Acetabular reaming during total hip arthoplasty (THA) o

Device Description

The main 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: knee procedures (per the predicate device K081867) and hip procedures (per RIO-Hip described in this 510(k) submission). 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. The robotic arm, once configured for a specific application (knee or hip), 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 describes the 510(k) summary for the MAKO Surgical Corp.'s Robotic Arm Interactive Orthopedic System - Hip (RIO-Hip). It indicates that performance data was collected but primarily focuses on claiming substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a comprehensive study report with quantified performance metrics.

Based on the provided text, here is the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
System Accuracy & Functionality	Satisfy all required acceptance criteria for setup, registration, and overall accuracy and functionality in supporting acetabular reaming during THA.	"The results of these tests satisfied all required acceptance criteria and were found to support substantial equivalence of the RIO-Hip to the predicate devices." (No specific numerical performance metrics are provided).
Intended Use Validation	Validate the system's intended use with cadaveric material by evaluating postoperative x-rays.	"Further testing was performed with RIO-Hip using cadaveric material where postoperative x-rays were obtained and evaluated in order to validate the system's intended use. The results... were found to support substantial equivalence of the RIO-Hip to the predicate devices." (No specific numerical performance metrics or validation criteria are provided).

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

Test Set:
- Sawbone Models: Used for "system level verification testing" to evaluate setup, registration, and overall accuracy/functionality. The specific number of sawbone models is not provided.
- Cadaveric Material: Used for "further testing" to validate the system's intended use. The specific number of cadaveric specimens is not provided.
Data Provenance: The studies were conducted in a laboratory setting by MAKO Surgical Corp. The country of origin is not explicitly stated but can be inferred as the USA (Florida) where the company is located. The studies appear to be prospective in nature, as they were conducted specifically for the purpose of this 510(k) submission.

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

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. The validation for the cadaveric study involved evaluating "postoperative x-rays," but it doesn't specify who performed this evaluation or what their qualifications were.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method for the test set, such as 2+1 or 3+1.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No information is provided about human readers improving with or without AI assistance, as the device is a robotic arm system for surgical assistance, not an AI for image interpretation or diagnosis.

6. Standalone Performance Study (Algorithm Only):

Yes, a standalone performance study was done for the device. The "System level verification testing" with sawbone models and "further testing" with cadaveric material directly assessed the performance of the RIO-Hip system. The description "algorithm only" is a bit of a misnomer here, as the device is an interactive robotic system, not just a diagnostic algorithm. However, its accuracy and functionality were tested independently of additional human interpretation in these studies.

7. Type of Ground Truth Used:

Sawbone Models: The ground truth would have been based on the engineered specifications and known anatomical landmarks of the sawbone models, likely established through precise measurements and design data.
Cadaveric Material: The ground truth for the cadaveric study would likely have been established through detailed anatomical measurements/assessments against established surgical goals and possibly validated by an expert (though not explicitly stated in the document). The "postoperative x-rays" were used for evaluation, implying a comparison against an expected or desired outcome.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. The focus is on validation testing rather than AI model training data.

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

As no information about a training set is provided, there is no information on how its ground truth was established.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for MAKO Surgical Corp. The logo features a stylized shark fin above the word "MAKO" in a bold, sans-serif font. Below "MAKO" is the text "SURGICAL CORP." in a smaller, sans-serif font.

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lori lauderdale, flonda 33317 2555 davie road tel 954 927 2044 fax 954.927.0446_

510(K) SUMMARY

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

MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL, 33317 954-927-2044 x 605 954-927-0446 William F. Tapia June 30, 2009 Robotic Arm Interactive Orthopedic System - Hip (RIO - Hip) 21 CFR 882.4560 Stereotaxic Instrument Class II OLO

Substantial Equivalence Claimed To: RIO – Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System - Hip (K083644), Tactile Guidance System v2.0 (K081867), Brainlab's Vectorvision Hip (K010602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364).

Description: The main 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: knee procedures (per the predicate device K081867) and hip procedures (per RIO-Hip described in this 510(k) submission). 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. The robotic arm, once configured for a specific application (knee or hip), 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.

Summary of Technological Characteristics Compared to Predicate Devices:

The technological characteristics of RIO-Hip compared to the predicate devices are listed below:

TechnologicalCharacteristics	RIO-Hip	Tactile Guidance System(K083644, K081867)	Brainlab Vectorvision(VV)(K010602, K040368,K052213, K072716)	Orthosoft NavitrackSystem - Total HipReplacement(K022364)
Major Components	Guidance Module,robotic arm, camerastand, drill system	Guidance Module, roboticarm, camera stand, drillsystem	Available in severaldifferent configurations(VV-Compact, VV-Sky,VV-2)	Computer cart.camera stand
Tools/accessories	Various probes, arraystracked by opticalcamera	Various probes, arraystracked by optical camera	Various probes, arraystracked by optical camera	Various probes, arraystracked by opticalcamera
Images Use	CT	CT	CT, CT-free	CT

Performance Data:

System level verification testing was performed in the laboratory with RIO-Hip using sawbone models to evaluate setup, reqistration, and overall accuracy and functionality of the system in supporting acetabular reaming during THA. Further testing was performed with RIO-Hip using cadaveric material where postoperative x-rays were obtained and evaluated in order to validate the system's intended use. The results of these tests satisfied all required acceptance criteria and were found to support substantial equivalence of the RIO-Hip to the predicate devices.

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Image /page/1/Picture/0 description: The image contains the text "K091998" underlined at the top left, and the text "Page 2 of 2" underlined at the top right. In the center of the image is the MAKO Surgical Corp. logo. The logo is a stylized arrow pointing upwards above the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters below.

2555 Davie Road	Fort Lauderdale, Florida 33317	tel: 954.587.2044	fax: 954.587.3475
-----------------	--------------------------------	-------------------	-------------------

Intended Use/Indications for Use:

Unicondylar knee replacement and/or patellofemoral knee replacement o
Acetabular reaming during total hip arthoplasty (THA) o

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.

SEP 28 2009

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

MAKO Surgical Corporation % Mr. William F. Tapia Director, Regulatory Affairs 2555 Davie Road Ft. Lauderdale, Florida 33317

Re: K091998

Trade/Device Name: RIO-Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: September 2, 2009 Received: September 3, 2009

Dear Mr. Tapia:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 Eederal Regulations Title 21 Barts 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. William F. Tapia

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/ucm111800 html 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 Port 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/cdrl/mdr/ 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 tolling the (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millhiser

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

Enclosure

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Kc. 9 1998

2555 davie road fort lauderdale, florida 33317 lel 954.927.2044 fax 954 927.0446

EXHIBIT 1

INDICATIONS FOR USE

510(k) Number (if known): K091998

Device Name: RIO-Hip

Indications for Use:

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 an probedures can be identified relative to a CT based model of the anatomy. These procedures include:

Unicondylar knee replacement and/or patellofemoral knee replacement o
0 Acetabular reaming during total hip arthoplasty (THA)

Prescription Use _ X

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. Graham
(Division Sign Off)

ion of Surgical, Orthopedic, Restorative Device

510(k) Number K091998

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).