(128 days)
The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, or Proficient® Posterior Cervical Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.
The Spine Wave® Navigated Instruments are reusable, manual, surgical instruments made from stainless steel. These instruments are to be used with the Medtronic StealthStation® System via the Medtronic NavLock™ Tracker to facilitate screw placement during cervicothoracic and thoracolumbosacral surgeries.
The provided document does not contain information about an AI/ML-driven medical device, an autonomous algorithm, or a study evaluating its performance. Instead, it is a 510(k) premarket notification for "Spine Wave Navigated Instruments," which are manual, reusable surgical instruments intended to be used with a navigation system (Medtronic StealthStation® System) to assist surgeons in precisely locating anatomical structures during spinal surgery.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them for an AI/ML device, nor can I provide information on multi-reader multi-case studies, standalone algorithm performance, or training/test set details related to AI/ML.
The "Performance Data" section (Section 8) simply states:
"Spine Wave, Inc. tested the subject devices in accordance with ASTM F2554 to demonstrate that the Spine Wave® Navigated Instruments are substantially equivalent to the predicates."
ASTM F2554 is a standard for "Standard Practice for Medical and Surgical Instruments and Devices, Requirements for Clinical Investigation Protocol." This standard outlines how to design a clinical investigation protocol for such devices, not the results of a performance study for an AI algorithm.
In summary, the provided text does not contain the information required to answer the question about acceptance criteria and study proving performance for an AI/ML medical device.
§ 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).