(61 days)
The Spineart Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Spineart Navigation Instrument System reusable instruments are specifically designed for use with the 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 a long bone or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.
The SPINEART® Navigation system includes the following instruments dedicated to screw placement: Screwdrivers, Taps, Drills.
The SPINEART® Navigation Instrument System is to be used with the following Spineart Systems:
RomeoⓇ2 Romeo®2 MIS PerlaⓇ Perla® TL Perla® TL MIS All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided non sterile.
The SPINEART® Navigation Instrument System instruments are not compatible with implants from other manufacturers.
The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation® System (V2.1.0) and the Medtronic NavLock® Tracker System.
This document (K241644) is an FDA 510(k) premarket notification for the "SPINEART Navigation Instrument System." This is a Class II medical device (Orthopedic Stereotaxic Instrument) with product code OLO, which includes surgical instruments intended to assist surgeons in precisely locating anatomical structures during spinal surgery for the placement of Spineart screws.
Based on the provided text, the submission is a "Special 510k" for a line extension, indicating that the device in question is a modification of a previously cleared device. The "Discussion of Testing" section explicitly states: "Addition of navigated instruments to SPINEART® Navigation Instrument System (K183630, K210472) does not require testing. An Engineering Analysis has been submitted to support substantial equivalence."
This clearly indicates that no new clinical study or performance study demonstrating the device meets specific acceptance criteria was conducted or submitted for this particular 510(k). Instead, the manufacturer relied on an engineering analysis to demonstrate substantial equivalence to previously cleared predicate devices (K183630 and K210472).
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, because this specific 510(k) submission states that no testing was required or performed for the new instrument additions.
The manufacturer's argument for clearance here is based on the new instruments having the same technological characteristics, indications for use, function, material composition, design, range of sizes, and presumed accuracy performance as the predicate devices that were previously cleared. The "engineering analysis" would have focused on demonstrating that these new instruments do not introduce new questions of safety or effectiveness.
§ 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).