(161 days)
Image Guided Surgical Instruments for Knee Applications are intended to assis the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure. such as a long bone. can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
Image Guided Surgical Instruments for Knee Applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are indicated for any medical condition of the knee in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
Example procedures include, but are not limited to:
Orthopedic Procedures:
Primary Total Knee Arthroplasty
Revison Total Knee Arthroplasty
Unicompartmental Knee Replacement
The Smith & Nephew Image Guided Instruments for Knee Applications are commercially available instruments that have been modified by incorporating a dovetail mount that will allow infrared LED (light emitting diodes) or passive markers image guided arrays to be fixed onto the instruments. This will allow the instruments to be tracked in real time in the surgical field.
Image Guided Surgical Instruments for Knee Applications are similar to currently legally marketed Class II stereotactic instruments in that they incorporate infrared LED (light emitting diodes) or passive markers onto the instruments that allow the instruments to be tracked in real time in the surgical field.
The provided text is a 510(k) Summary for Image Guided Surgical Instruments for Knee Applications. It details the device description, intended use, and substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance, a study conducted to prove performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document states that the new device is "similar to currently legally marketed Class II stereotactic instruments in that they incorporate infrared LED (light emitting diodes) or passive markers onto the instruments that allow the instruments to be tracked in real time in the surgical field." This indicates that the 510(k) submission relied on demonstrating substantial equivalence to existing devices, rather than presenting a new study with performance metrics against acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions about a study, as the provided text does not contain that information.
§ 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).