(204 days)
Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-Linkec System.
The Zavation Navigation instruments non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899
The provided text is a 510(k) summary for the Zavation Navigated Instrument System. It outlines the device description, indications for use, materials, and technological characteristics, as well as a list of predicate and reference devices. The "Performance Data" section mentions the types of testing performed but does not provide specific acceptance criteria or detailed results of those tests. It states:
- Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical System
- Mating Interface Assessments
- CMM Inspection
- Instrument Verification
It also mentions: "Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment."
Therefore, based only on the provided text, I cannot answer the questions comprehensively regarding specific acceptance criteria, reported device performance, sample sizes, expert involvement, or adjudication methods, as this detailed information is not present in the provided document.
The document primarily focuses on establishing "substantial equivalence" based on similar technological characteristics and types of performance testing, rather than reporting the quantitative results of those tests against specific acceptance criteria.
Therefore, I must state that the requested information (acceptance criteria, specific performance data, sample sizes, expert details, etc.) is NOT available in 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).