(188 days)
The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate, and where a 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 of the anatomy. The Stealth Station™ System is also indicated for intranasal or sinus use.
The Ultrasonic Probe Option provides the user with supplemental real time imaging information to be used to monitor soft tissue locations relative to the CT or MR based model of the anatomy.
This submission describes updates made to the StealthStation™ System to provide for optical tracking of an ultrasonic probe and its associated image plane.
I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for the StealthStation™ System - Ultrasonic Probe Attachment, which primarily focuses on establishing substantial equivalence to a predicate device.
It lacks details such as:
- Specific acceptance criteria: While it mentions "Performance data was provided to support the claim of substantial equivalence," it doesn't quantify what those criteria were.
- Reported device performance values: No numerical performance metrics are provided.
- Details about the study: There is no description of a study design, sample sizes, data provenance, expert qualifications, or adjudication methods.
- Information on MRMC comparative effectiveness or standalone studies.
- Details about the ground truth or training set for any potential AI/algorithm evaluation.
The document states that the StealthStation™ System - Ultrasonic Probe Attachment was shown to be substantially equivalent to the tracking of general surgical instruments in the original StealthStation™ System. This suggests that the "study" was likely a comparison to the performance of the predicate device, rather than a de novo clinical trial with specific performance metrics against an established ground truth.
Therefore, I cannot generate the table or answer the specific questions based on the provided text.
§ 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).