(372 days)
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), 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 unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
- Restoris Multicompartmental Knee System .
- Restoris Porous Partial Knee System ●
Partial Knee Application is an upgrade to RIO-PKA (K112507). The features of this application are to improve overall performance of the system in supporting partial knee arthroplasty. Partial Knee 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 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.
The provided document describes the MAKO Surgical Corporation's Partial Knee Application (PKA) device, which received 510(k) clearance from the FDA. The document summarizes various performance tests conducted to demonstrate the device's substantial equivalence to predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table summarizing the validation and verification methods, their acceptance criteria, and the results, as shown below:
| Validation / Verification Method | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|
| MICS Handpiece Functional Test | Intended to verify the MAKO Integrated Cutting System (MICS) requirements. | Pass |
| MICS Attachments Functional Test | Intended to verify that the straight sagittal saw blades met applicable specifications. | Pass |
| RIO Base Array Functional Test | Intended to verify that the Base Array assemblies when used with the Base Array Connector meet applicable specifications. | Pass |
| Bone Arrays and Clamps Functional Test | Intended to verify that the array movement is equal or less than the assembly requirement to a fixed position after cutting. | Pass |
| PKA Application Performance Test | Intended to verify that the real-time performance of the PKA application met applicable specifications. | Pass |
| Disposable Cutter Strength Testing | Intended to verify that the narrow saw blades met applicable specifications. | Pass |
| Bone Mineral Density (BMD) Application Functional Test | Intended to verify that the Bone Mineral Density function met applicable specifications. | Pass |
| Full System Run-through test | Intended to verify that the Partial Knee Application Software, and supporting instrumentation provides adequate functionality to be able to successfully complete a PKA procedure. | Pass |
| System Accuracy Test | The purpose of this test is to determine the overall system accuracy as a result of bone registration and bone resection accuracy. This protocol will use the verification results obtained from bone registration verification test and bone resection test and combine these results using a statistical approach. | Pass |
| PKA System Validation with MCK Implant system | Validate in a simulated-use environment that the integration of the Robotic Arm Interactive Orthopedic System (RIO) with the Partial Knee Application Software, MCK implant system and supporting instrumentation provides adequate functionality to successfully complete a Partial Knee Arthroplasty procedure and satisfies the customer requirements. | Pass |
| PKA System Validation with Restoris Porous Implant system | Validate in a simulated-use environment that the integration of the Robotic Arm Interactive Orthopedic System (RIO) with the Partial Knee Application Software, Restoris implant system and supporting instrumentation provides adequate functionality to successfully complete a Partial Knee Arthroplasty procedure and satisfies the customer requirements. | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document provides a list of tests and states "Pass" for each, but it does not specify the sample sizes used for any of the individual tests comprising the test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data). The studies are described as "nonclinical performance testing" and "simulated-use environment," indicating they were likely conducted in a lab or pre-clinical setting rather than with human patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The validation tests, particularly the "Full System Run-through test" and the "PKA System Validation," mention assessing "adequate functionality" and satisfying "customer requirements," which would implicitly involve expert assessment, but details are not given.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the tests (functional and system accuracy), it's more likely that predefined technical specifications were used as criteria rather than a consensus among multiple human adjudicators for subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The studies described are focused on the device's functional performance and accuracy, not on comparing the performance of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done:
The "Partial Knee Application (PKA)" is described as being "intended to assist the surgeon" and "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 "RIO's robotic arm... can serve as surgeon's 'intelligent' tool holder or tool guide." This clearly indicates a design for "human-in-the-loop" operation. Therefore, a standalone (algorithm-only) performance study is not explicitly described or implied as being relevant given the device's assistive nature. However, certain functional tests (e.g., System Accuracy Test, PKA Application Performance Test) would evaluate the algorithm's performance independent of surgical action, but within the context of ultimately assisting a surgeon.
7. The Type of Ground Truth Used:
The ground truth for most of these tests appears to be based on engineering specifications and predefined performance metrics. For example, the "System Accuracy Test" aims to determine "overall system accuracy as a result of bone registration and bone resection accuracy." This implies a comparison against a known, accurate standard or measurement. For the "Full System Run-through test" and "PKA System Validation," the ground truth would be the successful completion of the PKA procedure according to established clinical protocols and "customer requirements" (likely derived from surgical best practices and outcomes) in a simulated environment. There is no mention of pathology or long-term outcomes data used as ground truth in these nonclinical tests.
8. The Sample Size for the Training Set:
The document does not provide any information regarding the sample size for a training set. As this device seems to be a complex robotic surgical assistance system, there would undoubtedly be internal development and training data used for its algorithms and software. However, such details are not disclosed in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
Similar to question 8, the document does not provide information on how the ground truth for any potential training set was established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
MAKO Surgical Corporation Mr. Jonathan Reeves Principal Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K142530
Trade/Device Name: Partial Knee Application (PKA) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 8, 2015 Received: August 10, 2015
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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Page 2 - Mr. Jonathan Reeves
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142530
Device Name Partial Knee Application (PKA)
Indications for Use (Describe)
The Partial Knee Application (PK A), for use with 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 Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), 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 unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
- · Restoris Multicompartmental Knee System
- · Restoris Porous Partial Knee System
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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Image /page/3/Picture/0 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 wave or a stylized mountain range.
555 Davie Road • Ft. Lauderdale, FL one 954.927.2044 • Fax 954.927.0 ww.makosurgical.com
510(K) SUMMARY
| Submitter: | MAKO Surgical Corp. |
|---|---|
| Address: | 2555 Davie Road, Fort Lauderdale, FL 33317 |
| Phone number: | 954-628-0655 |
| Fax number: | 954-927-0446 |
| Contact Person: | Jonathan Reeves |
| Date Prepared: | Aug 29, 2014 |
| Device Trade Name: | Partial Knee Application (PKA) |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |
Primary Predicate Device:
Partial Knee Application is substantially equivalent to the following 510(k) cleared device:
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| RIO – PKA (Partial Knee Application) | MAKO Surgical | K112507 |
Additional Predicate Devices:
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| RIO - TKA (Total Knee Application) | MAKO Surgical | K143752 |
Device Modifications: The following modifications have been made to RIO Partial Knee Application:
- A power tool to perform the cutting for partial knee arthroplasty (MAKO ● Integrated Cutting System (MICS)) has been added to the system.
- Accessories (drills, burrs, blades and attachments) for the MICS cutting system have been added to the system
- A bone mineral density (BMD) phantom has been added to the system which ● allows the system to display the CT scan on a density scale in standard units. The BMD feature is intended to provide the surgeon with a means to assess bone density.
- . Instrumentation (arrays, bone pins, gap spoons) have been modified or added to the system to improve the usability of the system
- . The ability to implant the Restoris Porous implant system using the RIO system was added to the system.
- . Motorized tool alignment for the RIO setup has been added to the system to improve ease of use.
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- Range of motion increase on RIO to improve ease of use. ●
Description: Partial Knee Application is an upgrade to RIO-PKA (K112507). The features of this application are to improve overall performance of the system in supporting partial knee arthroplasty. Partial Knee 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 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.
| Summary of Technological Characteristics Compared to Predicate Devices: The | |
|---|---|
| technological characteristics of Partial Knee Application compared to the predicate | |
| device are listed below: |
| TechnologicalCharacteristics | Partial KneeApplication | RIO-PKA(K112507) | RIO-TKA(K143752) |
|---|---|---|---|
| MajorComponents | GuidanceModule, roboticarm, camerastand, cuttingsystem,preoperativeplanning laptop. | Guidance Module,robotic arm, camerastand, cutting system,preoperative planninglaptop. | Guidance Module,robotic arm, camerastand, cuttingsystem,preoperativeplanning laptop. |
| Tools/accessories | Various reusableinstruments | Various reusableinstruments | Various reusableinstruments |
| Images Use | CT | CT | CT |
Intended Use/Indications for Use
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures, in which the
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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.
The Implant systems with which the system is compatible:
- Restoris Multicompartmental Knee System .
- Restoris Porous Partial Knee System ●
Performance Data:
The Robotic Arm Interactive Orthopedic System (RIO) has been evaluated through nonclinical performance testing for:
| Validation / Verification | Acceptance Criteria | Validation / Verification |
|---|---|---|
| Method | Results | |
| MICS HandpieceFunctional Test | This verification test isintended to verify theMAKO Integrated CuttingSystem (MICS)requirements. | Pass |
| MICS AttachmentsFunctional Test | This verification test isintended to verify that thestraight sagittal saw bladesmet applicablespecifications. | Pass |
| RIO Base Array FunctionalTest | This verification test isintended to verify that theBase Array assemblieswhen used with the BaseArray Connector meetapplicable specifications. | Pass |
| Bone Arrays and ClampsFunctional Test | This verification test isintended to verify that thearray movement is equal orless than the assemblyrequirement to a fixedposition after cutting. | Pass |
| PKA ApplicationPerformance Test | This verification test isintended to verify that thereal time performance of thePKA application metapplicable specifications. | Pass |
| Disposable Cutter StrengthTesting | This verification test isintended to verify that thenarrow saw blades met | Pass |
| applicable specifications. | ||
| Bone Mineral DensityApplication Functional Test | This verification test isintended to verify that theBone Mineral Densityfunction met applicablespecifications. | Pass |
| Full System Run-throughtest | This verification test isintended to verify that thePartial Knee ApplicationSoftware, and supportinginstrumentation providesadequate functionality to beable to successfullycomplete a PKA | Pass |
| System Accuracy Test | The purpose of this test is todetermine the overallsystem accuracy as a resultof bone registration andbone resection accuracy.This protocol will use theverification results obtainedfrom bone registrationverification test and boneresection test and combinethese results using astatistical approach. | Pass |
| PKA System Validationwith MCK Implant system | Validate in a simulated-useenvironment that theintegration of the RoboticArm Interactive OrthopedicSystem (RIO) with thePartial Knee ApplicationSoftware, MCK implantsystem and supportinginstrumentation providesadequate functionality tosuccessfully complete aPartial Knee Arthroplastyprocedure and satisfies thecustomer requirements. | Pass |
| PKA System Validationwith Restoris PorousImplant system | Validate in a simulated-useenvironment that theintegration of the RoboticArm Interactive OrthopedicSystem (RIO) with the | Pass |
| Partial Knee Application | ||
| Software, Restoris implant | ||
| system and supporting | ||
| instrumentation provides | ||
| adequate functionality to | ||
| successfully complete a | ||
| Partial Knee Arthroplasty | ||
| procedure and satisfies the | ||
| customer requirements. |
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Conclusions of Non-clinical Data:
The results of testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate device.
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§ 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).