(94 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 svstem 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.
The provided text is a 510(k) summary for the MAKO Partial Knee Application. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the acceptance criteria and detailed study information requested in your prompt (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, or details about standalone or MRMC studies).
The "Performance Data" section briefly lists three types of non-clinical performance testing:
- Cutting Accuracy Verification
- Cadaver Validation of Mako System with New Burr
- Biocompatibility Evaluation
It concludes that these tests "demonstrate 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 and does not raise new questions of safety and effectiveness, and therefore supports a determination of Substantial Equivalence."
Therefore, based only on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or expert involvement. The document focuses on regulatory equivalence rather than a detailed breakdown of performance study results.
§ 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).