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 (K121064). 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, cutting system, and a robotic arm. The system's architecture is designed to support two main surgical applications: total hip procedures and partial knee procedures. 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

Here's an analysis of the provided text regarding the acceptance criteria and study information for the MAKOplasty Total Hip Application, based on the requested format.

It's important to note that the provided document is an FDA 510(k) K141989 summary which often has specific limitations in detailing study methodology, especially for performance data. Much of the requested information (e.g., specific sample sizes for test/training, number and qualifications of experts, adjudication methods, MRMC studies, specific ground truth types with details) is not explicitly stated in this type of document. The summary focuses on demonstrating substantial equivalence through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria alongside corresponding reported device performance values in the way one might expect from a detailed study report. Instead, it lists "Non-clinical Performance Testing" and states a general conclusion.

Acceptance Criterion (Inferred/General)	Reported Device Performance
RIO Arm and MICS Communication	Performed as intended
MICS Handpiece Functional Test	Performed as intended
MICS Cover Functional Test	Performed as intended
Inline Offset Cup Impactor Thread Connection Functional Test	Performed as intended
MICS Reamer Attachment Functional Test	Performed as intended
RIO Base Array Functional Test	Performed as intended
THA Application Performance Test	Performed as intended
Full System Test	Performed as intended
Safety and Efficacy (General)	No new safety and efficacy issues raised; device found to be substantially equivalent.

Explanation: The document lists several "non-clinical performance tests" and concludes that "The results of testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues." This implies that the acceptance criteria for each of these tests were met, demonstrating the device's functionality and safety. However, the specific quantitative pass/fail criteria for each test (e.g., what constitutes "working as intended" for a communication test, or a specific tolerance for a functional test) are not detailed.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "non-clinical performance testing" which typically involves bench testing, simulated use, and potentially cadaveric studies, rather than a "test set" in the context of clinical data.
Data Provenance: Not applicable in the context of clinical data. The tests described are non-clinical, likely conducted in a lab or simulated environment.

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

Number of Experts: Not applicable/not stated. For non-clinical functional and performance tests, "ground truth" is typically established by engineering specifications, calibration standards, or simulated outcomes, rather than expert consensus on patient data.
Qualifications of Experts: Not applicable/not stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Given the non-clinical nature of the tests, an adjudication method for conflicting expert opinions on a data set is not relevant. Performance is measured against predetermined engineering or functional specifications.

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

MRMC Study: No. The document does not mention an MRMC comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. The MAKOplasty Total Hip Application is a robotic surgical assistance system, not an AI diagnostic tool that human readers would interpret.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no such study is described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Standalone Study: Yes, in the sense of the defined "non-clinical performance testing." The tests listed (e.g., RIO Arm and MICS communication, functional tests) evaluate the device's components and system functionality in a controlled, non-human-in-the-loop environment. The device assists a surgeon; these tests determine if the assistance system itself works as intended algorithmically and mechanically.

7. The Type of Ground Truth Used

Ground Truth Type: For the non-clinical performance tests, the "ground truth" is likely based on:
- Engineering Specifications: Whether components communicate correctly, threads connect properly, and mechanical parts function within defined tolerances.
- Simulated Outcomes: Verification that the system performs its intended function (e.g., provides correct spatial boundaries, achieves desired reaming accuracy in a simulated environment) as per design goals.
- Design Requirements: Conformance of the system's output to its specified design requirements.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/not stated. The document describes a robotic surgical assistance system. While such systems involve complex algorithms, the development process (including feature training or calibration) would be part of the overall design and verification/validation, but a specific "training set" in the context of a machine learning-based diagnostic algorithm on a dataset is not described or implied for this device's 510(k) submission. Pre-operative planning uses patient CT data, but that's for individual patient planning, not for training a general algorithm.

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

Ground Truth for Training Set: Not applicable/not stated, for the reasons outlined in point 8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

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

November 13, 2014

Mako Surgical Corporation Mr. Jonathan Reeves Principal Regulatory Specialist 2555 Davie Road Fort Lauderdale, Florida 33317

Re: K141989

Trade/Device Name: MAKOplasty Total Hip Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 8, 2014 Received: October 14, 2014

Dear Mr. Reeves:

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

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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 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. 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 Industry and Consumer Education 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 vours.

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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Image /page/2/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features a stylized blue arc above the word "MAKO" in bold, black letters. Below "MAKO" is the text "SURGICAL CORP." in a smaller, less bold font, also in black. The logo is clean and modern, with the blue arc providing a visual element that suggests movement or technology.

555 Davie Road • Ft. Lauderdale, FL 2044 • Fax 954.927.0 ww.makosurgical.com

INDICATIONS FOR USE

510(k) Number: K141989

Device Name: Total Hip Application (THA)

Indications for Use:

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

Prescription Use

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)

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Image /page/3/Picture/0 description: The image is a logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below the word "MAKO" is the phrase "SURGICAL CORP." in smaller, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or an abstract mountain range.

1555 Davie Road • Ft. Lauderdale, FL 33317 hone 954.927.2044 • Fax 954.927.0446 ww.makosurgical.com

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 Jonathan Reeves July 03, 2014 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 K121064.

Device Modifications:

MAKO Integrated Cutting System (MICS)
Inline offset cup impactor ●
MICS endcap
. Reamer attachment
4.0mm bone pins
RIO Base Array
Reduction Results: hip length and combined offset

Device Description: MAKOplasty Total Hip Application is an upgrade to RIO-THA (K121064). 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.

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procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.

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(K121064)
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 instruments	Various reusable instruments
	Images Use	CT	CT

Intended Use/Indications for Use

Unicondylar knee replacement and/or patellofemoral knee replacement ●
Total hip arthroplasty (THA) .

Performance Data:

The Robotic Arm Interactive Orthopedic System (RIO) has been evaluated through nonclinical performance testing for:

RIO arm and MICS communication Test ●
MICS Handpiece Functional Test ●
MICS Cover Functional Test
Inline Offset Cup Impactor Thread Connection Functional Test
MICS Reamer Attachment Functional Test
RIO Base Array Functional Test ●
THA Application Performance Test ●
Full System Test ●

Conclusions of Non-clinical Data:

The results of testing indicated the device performed within the intended use and

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did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices.

Summary of Design Control Activities:

The risk analysis activities for this device modification include a risk management plan, hazard analysis and Failure Modes and Effects Analysis (FMEAs). Based upon the review of this data and information obtained through verification and validation activities, there are no unacceptable levels of risks that have been identified resulting from the device modification.

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).