(58 days)
The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or perculaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate. Anatomical structures, such as those in the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures: Cranial Biopsies Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement
Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement
ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Knee Procedures
This submission describes updates made to the Imageless Knee Module for the StealthStation to incorporate the AxiEM™ electromagnetic navigation technology.
The provided text is a 510(k) summary for the Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module. It does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document primarily focuses on the device description, indications for use, and a statement of substantial equivalence to previously marketed devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- MRMC comparative effectiveness study details (effect size)
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
§ 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).