(133 days)
The EUROPA™ Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation® System, which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The EUROPA™ Navigated Instruments is intended to be used with the EUROPA™ Pedicle Screw System. The EUROPA™ Navigated Instruments are non-sterile, re-usable instruments including probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation ® System and are manufactured from Stainless Steel per ASTM F899.
The provided text does NOT include acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the "EUROPA™ Navigated Instruments."
This type of document primarily focuses on establishing substantial equivalence to already legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria, test sets, ground truth establishment, or human reader performance metrics. The information provided is high-level and generalized, stating that "Design validation testing included testing per ASTM F2554-18, and a one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the EUROPA™ Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy, and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments."
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them from the provided text. The document does not contain the information required to construct the table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details.
§ 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).