(293 days)
The EXACTECH GPS is intended for use during stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for primary and revision Total Knee Arthroplasty.
The EXACTECH GPS is an Image Guided Surgery, or Navigation, system for orthopedic surgical procedures intended to be used to intraoperatively assist surgeons during total knee arthroplasty. The EXACTECH GPS enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.
The provided document describes the EXACTECH GPS, a stereotaxic instrument intended for use during total knee arthroplasty to locate anatomical structures and align endoprostheses. The product is a submission for changes to the original EXACTECH GPS (K100742), specifically regarding sterile battery sterilization packaging and the introduction of Revision Total Knee Application software.
The document includes a summary of Safety and Effectiveness for the EXACTECH GPS, outlining testing related to the new Revision Total Knee Application software. This testing includes Design Verification (including accuracy testing) and Design Validation (including cadaveric sessions) to demonstrate substantial equivalence to the predicate device.
However, the document does not explicitly provide a detailed table of specific acceptance criteria and reported device performance metrics for the software's accuracy, nor does it detail the specific study methodology or results proving the device meets these criteria. The text only broadly states that "performance specifications: the proposed modifications do not affect device accuracy and/or performance."
Therefore, based on the provided text, I cannot complete points 1 through 9 with specific quantitative data. The information is not detailed enough to extract those specifics.
The document states:
- Testing: "Revision Total Knee Application software: - Design Verification (including accuracy testing) - Design Validation (including cadaveric sessions)"
- Substantial Equivalence Conclusion: "Proposed device was tested during engineering studies and testing ensures Results of engineering studies and cadaveric sessions referenced in this 510(k) submission demonstrate the proposed EXACTECH GPS is substantially equivalent to the predicate."
This implies that some form of accuracy testing was performed during Design Verification and usability/effectiveness testing in cadaveric sessions during Design Validation. However, the specific metrics, thresholds, sample sizes, and expert details for these studies are not disclosed in this summary.
In summary, while the document confirms that accuracy and cadaveric studies were performed to support the device's substantial equivalence, it does not provide the detailed information required to fill out the requested table and answer the specific questions about acceptance criteria, study design, and performance metrics.
§ 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).