(88 days)
NaviPro™ is a system for computer-aided navigation of surgical instruments whose purpose is to optimally position the acetabular shell during hip replacement surgery, and to report changes in rotational center, limb length, and femoral offset as a result of prosthetic implantation. The system aids the surgeon in accurately positioning the acetabular shell during hip replacement and provides intra-operative measurements of femoral position and orientation in relation to the pelvis. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
NaviPro™ uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during hip replacement surgery. Measurements obtained from the system allow for intra-operative assessments of implant position and orientation.
NaviPro™ intra-operatively reports the position of the acetabular shell relative to the pelvis as well as the changed relationship between femur and pelvis as a result of joint replacement. The patient data needed to carry out this procedure is recorded intra-operatively. Pre-operative CT or fluoroscopic imaging is unnecessary. The link between patient and computer is established by infra-red reflective trackers that are securely attached to the patient. An infra-red localizing camera that is linked to the computer calculates the position and orientation of the trackers.
Surgical instruments, such as an acetabular shell impactor tool and a calibrated measurement probe, are also outfitted with infra-red trackers and can be brought into a spatial relationship with the patient. The NaviPro™ system requires only the information provided by the trackers to determine the orientation of the acetabular shell, as well as changes in limb length and femoral offset.
The provided text, K020764, describes the NaviPro™ system, a computer-aided surgical navigation system for hip replacement surgery. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary and the FDA's clearance letter, which focuses on:
- Device description: How NaviPro™ uses optical tracking to determine the spatial position of bones and instruments during hip replacement surgery.
- Intended use: Positioning the acetabular shell, reporting changes in rotational center, limb length, and femoral offset.
- Technological characteristics: Infra-red reflective trackers, an optical localizing camera, and intra-operative measurements without pre-operative imaging.
- Substantial equivalence: Claimed to OrthoPilot® (K003347).
- FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and is cleared for market.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided text.
The 510(k) process generally relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and detailed performance studies like those required for a PMA (Premarket Approval) application. While studies are often submitted as part of a 510(k), the provided summary does not detail them.
§ 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).