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The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as 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.

The AxiEM™ Imageless Hip Module for the StealthStation® is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision)

The AxiEM™ Imageless Hip Module for the StealthStation® System provides a mechanism for the establishment of stereotactic coordinates without the use of a pre-operative or intra-operative image using electromagnetic navigation

The provided text does NOT include acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the AxiEM™ Imageless Hip Module for the StealthStation® System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

The document discusses:

• Manufacturer and Contact Information
• Product Name and Classification
• Date Summary Submitted
• Description of Device Modification: States that the AxiEM™ Imageless Hip Module uses electromagnetic navigation instead of optical tracking (the primary difference from its predicate).
• Substantial Equivalence: Claims substantial equivalence to the Imageless Hip Module for the StealthStation® System (K052623) and highlights the difference from the AxiEM™ Imageless Knee Module (hip vs. knee procedures). It vaguely mentions that "all verification and validation activities will be performed... and will demonstrate the safety and effectiveness of the device," but does not provide details about these activities, specific acceptance criteria, or study results.
• Indications for Use
• FDA Letter of Substantial Equivalence: This letter confirms that the FDA reviewed the 510(k) and determined the device is substantially equivalent to predicate devices, thus allowing it to be marketed. It reiterates that substantial equivalence does not mean the device complies with all other requirements of the Act, such as GPM, labeling, etc.

Therefore, I cannot populate the requested table or provide information on the study, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness, as this information is not present in the provided text.

The document only serves as a regulatory submission for market clearance based on substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as 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.

The Imageless Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
Tumor Resection and Bone/Joint Reconstruction
Placement of Iliosacral Screws
Femoral Revision
Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

The Imageless Hip Module for the StealthStation® System is the Imageless Hip Module provides a mechanism that enables the establishment of stereotactic coordinates without the use of a preoperative or intra-operative images.

The provided text does not contain detailed information about acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, number of experts, their qualifications, and adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used, training set sample size, and how training set ground truth was established.

The document is a 510(k) premarket notification for the "Imageless Hip Module for the StealthStation® System." It states that the device is substantially equivalent to a predicate device (Hip Module for the StealthStation® System, K021980) based on accuracy testing provided in the filing and a risk analysis. However, the specifics of this accuracy testing are not described in the provided text.

The text focuses on the device's description, classification, and indications for use, and the FDA's determination of substantial equivalence. It confirms that "all verification and validation activities performed by designated individuals and the results demonstrated substantial equivalence," but does not elaborate on these activities or their outcomes in a way that would answer the specific questions posed.

Ask a specific question about this device