(58 days)
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Mako System, 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
The Mako System with the Partial Knee 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/haptic 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.
This document is a 510(k) summary for the Mako Partial Knee Application, a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the typical sense of an AI/ML device performance study with traditional metrics like sensitivity, specificity, or AUC.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Mako Surgical's Partial Knee Application cleared via K142530), based on technological characteristics and functional performance testing.
Therefore, I cannot extract the requested information regarding acceptance criteria, study design, ground truth establishment, or human reader performance for an AI/ML system from this document. The "Performance Data" section describes non-clinical performance testing for a robotic surgical assistance system, not an AI/ML diagnostic or prognostic tool.
Here's a breakdown of why the requested information cannot be provided based on the input document:
- Acceptance Criteria and Reported Device Performance (Table): Not present. The document discusses "performance testing" but not in the context of quantitative metrics for an AI/ML model. It lists activities like "Sub-system level software functional testing" and "Resection accuracy verification," but no specific numerical acceptance criteria or results are given.
- Sample Size and Data Provenance (Test Set): Not applicable in the context of AI/ML validation data. The performance testing mentions "Full system cadaver validation," which implies a small, non-human sample for mechanical/software function verification, not a large patient-data test set.
- Number/Qualifications of Experts for Ground Truth: Not applicable. Ground truth, in the AI/ML sense, refers to labeling of patient data, which is not described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned or implied. This device is a surgical assistance system, not an imaging interpretation AI for human reader improvement studies.
- Standalone (Algorithm-only) Performance: Not applicable as it's a robotic system with human interaction.
- Type of Ground Truth: Not applicable in the AI/ML data labeling sense. The "ground truth" for this device's performance would be the physical accuracy of the robotic arm's movements and resections compared to a planned trajectory.
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that learns from a training set of data in the typical sense. Its software is programmed to assist with surgical procedures.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document describes a robotic surgical assistance system that aims to demonstrate substantial equivalence through a series of non-clinical performance and functional tests, rather than an AI/ML system that undergoes a clinical validation study with specific performance metrics and patient data.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2017
MAKO Surgical Corp. Shikha Khandelwal Staff Regulatory Affairs Specialist 2555 Davie Rd Fort Lauderdale, Florida 33317
Re: K170891
Trade/Device Name: Mako Partial Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 24, 2017 Received: March 27, 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 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,
Vincent J. Devlin -S
for
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
Partial Knee Application
Indications for Use (Describe)
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Mako System, 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
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/1 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 an abstract mountain range.
t. Lauderdale, Fl 44 · Fax 954.927.0
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: March 21, 2017
Proprietary Name: Mako Partial Knee Application
Common Name: Partial Knee Application (PKA)
Regulation Name: Stereotaxic Instrument
Regulation Number: 21 CFR 882.4560
Device Classification: Class II
Product Code: OLO
Substantial Equivalence Claimed To:
The Mako Partial Knee Application is substantially equivalent to Mako Surgical's Partial Knee Application cleared via K142530.
Device Modifications: The following changes have been made to the Mako Partial Knee Application:
- Labeling Implant compatibility has been modified in the Indications for Use and labeling.
- · Software
- o Implant compatibility has been modified
- o Setup and bone preparation steps have been updated to enhance workflow and usability
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Description:
The Mako System with the Partial Knee 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/haptic 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.
| TechnologicalCharacteristics | Mako Partial Knee Application | Mako Partial Knee Application(K142530) |
|---|---|---|
| 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 |
Summary of Technological Characteristics Compared to Predicate Devices: The technological characteristics of the Mako Partial Knee Application compared to
Intended Use/Indications for Use:
the predicate device are listed below:
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Mako System, 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:
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-
Restoris Multicompartmental Knee System
Performance Data - The Mako System has been evaluated through the following non-clinical performance testing: -
Sub-system level software functional testing of Setup and Bone Preparation steps
-
Implant visuals, boundaries and stereotactic verification ●
-
Resection accuracy verification
-
Full system mock procedure run-through verification
-
Full system cadaver validation ●
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the Mako Partial Knee 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.
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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).