(268 days)
The RobPath® Total Hip Application is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RobPath® Total Hip Application 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 proposed RobPath® Total Hip Application is a semi-active robotic system. Pre-operative CT imaging is used to generate a 3D model of the native hip joint. An initial plan is created using selected CT landmarks and superimposed onto the 3D reconstruction. The surgeon is then able to fine-tune this to ensure optimal templating of component size and alignment, thus allowing the desired restoration of hip biomechanics, bone coverage, component positioning and leg-length correction. The robotic arm is not fully automated but based on haptic feedback, so the surgeon retains partial control during the implantation.
The provided text does not contain specific acceptance criteria or details of a study directly proving the RobPath® Total Hip Application meets such criteria. Instead, it states that "Non-Clinical verification and validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications, and the risk management results," and that "The results of these tests demonstrate that the proposed RobPath-THA-001 meet the acceptance criteria and is adequate for its intended use."
The document focuses on establishing substantial equivalence to a predicate device (MAKO Total Hip Application, K193128) based on technological characteristics and adherence to various international and FDA-recognized consensus standards. It explicitly states that no clinical study was required because substantial equivalence was proven through verification/validation testing.
Therefore, I cannot provide the requested information for an acceptance criteria table, sample size, expert qualifications, adjudication methods, MRMC study results, standalone performance, or details on ground truth for training or test sets, as this information is not present in the provided text.
The closest information related to performance is the mention of adherence to standards like ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This implies that the device's positional accuracy would be a key acceptance criterion, and testing defined by this standard would have been performed, but the specific numerical acceptance criteria and reported performance are not detailed.
§ 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).