(49 days)
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 Make System 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)
The Mako System with the Total Hip 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 stereotactic 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.
The Mako 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 Mako Total Hip 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 device is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, specifically Total Hip Arthroplasty (THA).
The device in question is a modification of a previously cleared device (K141989), with the modification being "An alternate online portal for case management and file transfer known as eRequest LifeCycle is being implemented for use during the preoperative planning phase of the Mako Total Hip Application." Therefore, the validation and verification focused on ensuring that this new portal and its integration did not negatively impact the existing functionalities or introduce new risks.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Specification Verification | THA fields and values implemented into the eRequest application must match the THA Product Specifications. | Pass |
| eRequest – Full System Run Through for THA Application | The integration of the eRequest Lifecycle into the Mako System provides adequate functionality to successfully complete the pre-operative planning workflow. | Pass |
| eRequest LifeCycle THA Validation | In a simulated-use environment, with appropriate user, the implementation of eRequest LifeCycle into the Mako System provides adequate functionality to successfully complete the pre-operative workflow and satisfies the customer requirements. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests described are functional verification and validation steps for software integration rather than clinical performance studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set. The validation appears to be based on product specifications and user requirements, likely assessed by internal development and quality assurance teams, potentially with input from clinical users or subject matter experts in surgical workflows, but this is not detailed.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (such as 2+1 or 3+1). The tests are described as "Pass/Fail" based on whether the acceptance criteria were met.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The device is a surgical planning and guidance system for Total Hip Arthroplasty (THA), and the specific tests mentioned focus on the software integration of a new case management portal. There is no information provided regarding studies on human reader performance with or without AI assistance for this device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone algorithm-only performance study was not explicitly done or detailed in the provided text. The device is inherently a "human-in-the-loop" system, assisting surgeons. The testing focused on the functionality of the new eRequest LifeCycle within the overall Mako System, which is for pre-operative planning.
7. Type of Ground Truth Used
The "ground truth" for these tests appears to be product specifications, documented pre-operative planning workflows, and customer requirements. These are largely functional and performance specifications for the software system and its integration, rather than clinical ground truth like pathology, expert consensus on imaging, or outcomes data.
8. Sample Size for the Training Set
The document does not specify any sample size for a training set. Given the nature of the modification (a new online portal for case management), this is unlikely to involve a machine learning model that requires a training set in the conventional sense. The "training" here would refer to software development and testing cycles rather than data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of the device's modification, the document does not describe how ground truth for a training set was established.
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April 18, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mako Surgical Corp. Shikha Khandelwal Staff Regulatory Affairs Specialist 2555 Davie Rd Fort Lauderdale, Florida 33317
Re: K170593
Trade/Device Name: Mako Total Hip Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 30, 2017 Received: March 31, 2017
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. 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-
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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 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/ResourcesforYou/Industry/default.htm. 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
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,
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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Indications for Use
510(k) Number (if known)
Device Name
Mako Total Hip 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. The Make System 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)
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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55 Davie Road • Ft. Lauderdale, FL 3331 7.2044 • Fax 954.927.04 ww.makosuraical.com
K170593 - Page 1 of 3
510(K) SUMMARY
Sponsor:
MAKO Surgical Corp. 2555 Davie Road Fort Lauderdale, FL 33317
Contact Person:
Shikha Khandelwal, PhD Shikha.khandelwal@stryker.com Phone: 201-831-6921 Fax: 201-831-3921
Date Prepared: February 24, 2017
Proprietary Name: Mako Total Hip Application
Common Name: Total Hip Application (THA)
Regulation Name: Stereotaxic Instrument
Regulation Number: 21 CFR 882.4560
Device Classification: Class II
Product Code: OLO
Substantial Equivalence Claimed To:
The Mako Total Hip Application is substantially equivalent to Mako Surgical's Total Hip Application cleared via K141989.
Device Modification: An alternate online portal for case management and file transfer known as eRequest LifeCycle is being implemented for use during the preoperative planning phase of the Mako Total Hip Application.
Description:
The Mako System with the Total Hip 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.
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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 stereotactic 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.
The Mako 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 the Mako Total Hip Application compared to the predicate device are listed below:
| TechnologicalCharacteristics | Mako Total Hip Application | Mako Total Hip Application(K141989) |
|---|---|---|
| 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 and disposableinstruments | Various reusable and disposableinstruments |
| Image Use | CT | CT |
Intended Use/Indications for Use:
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 and hip 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:
- Unicondylar knee replacement and/or patellofemoral knee replacement
- Total Hip Arthroplasty (THA) .
Performance Data:
| Validation / VerificationMethod | Purpose | Validation / VerificationResults |
|---|---|---|
| Product SpecificationVerification | Verify that THA fields andvalues implemented intothe eRequest applicationmust match the THA | Pass |
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| Product Specifications. | ||
|---|---|---|
| eRequest – Full SystemRun Through for THAApplication | Verify the integration ofthe eRequest Lifecycleinto the Mako Systemprovides adequatefunctionality tosuccessfully complete thepre-operative planningworkflow | Pass |
| eRequest LifeCycle THAValidation | Validate in a simulated-use environment, withappropriate user, that theimplementation ofeRequest LifeCycle intothe Mako System providesadequate functionality tosuccessfully complete thepre-operative workflowand satisfies the customerrequirements. | Pass |
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the Mako Total Hip Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness, and therefore, supports a determination of Substantial Equivalence.
§ 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).