(60 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 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:
· Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
- · Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary)
- · Triathlon Total Knee System (TS inserts cemented primary)
The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, camera, a computer, dedicated instrumentation, operating software, 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 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.
Once configured for a specific application, the Mako robotic-arm can serve as the 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 text is a 510(k) Summary for the Mako Total Knee Application, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and comparative technological characteristics. However, it does not contain the specific details required to answer your questions regarding acceptance criteria, study methodologies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance), or ground truth establishment.
The document states: "Performance Data - The modified Mako System with the subject Mako Total Knee Application has been evaluated through the following non-clinical performance testing: Software Functional Testing, Cutting System Accuracy, Cable Reliability, Software Performance Verification, System Testing, Cadaveric Design Validation, Summative Evaluation."
While it lists categories of testing, it does not provide the acceptance criteria for these tests, nor does it detail the specific results, sample sizes, number or qualifications of experts, or ground truth methods used in any of these evaluations. It only concludes that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device."
Therefore, I cannot provide the requested information based on the text provided. The document focuses on regulatory justification for substantial equivalence rather than a detailed technical report of the validation studies conducted to prove performance against specific acceptance criteria.
§ 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).