(82 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 a surgical hip procedure 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 Hip Arthroplasty (THA)
The Mako System with the subject 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/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 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) Pre-Market Notification from the FDA regarding the Mako Total Hip Application. It is a clearance document for a medical device that assists surgeons during Total Hip Arthroplasty (THA) procedures through stereotactic/haptic guidance.
However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
Specifically, the document states:
- "Performance Data - The Mako System has been evaluated through the following non-clinical performance testing: Software testing, Instrument performance testing, Mako Total Hip Application full system run through, Bone registration accuracy verification, Implant models and visuals verification, Full system cadaver validation, Biocompatibility verification."
- "Conclusions of Performance Testing: Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application are equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing supports a determination of Substantial Equivalence."
This outlines the types of tests performed and the conclusion of substantial equivalence, but it does not provide the specific numerical acceptance criteria, the reported performance metrics, sample sizes, data provenance, expert qualifications for ground truth, adjudication methods, or details about training sets.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.
§ 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).