(235 days)
Spineology Navigation Instruments are indicated for use during the preparation and placement of:
- Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ pedicle screws .
- Spineology's OptiMesh® Portal Assembly .
during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous orthopedic procedures.
These instruments are designed for use with the Medtronic StealthStation® Spine 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 the spine or pelvis, can be identified relative to images of the anatomy.
Spineology Navigation Instruments are non-sterile, reusable surgical instruments that are manufactured from stainless steel and operated manually.
Spineology Navigation Instruments for Pedicular Fixation include Awls, Bone Taps, Drills, and Screwdrivers. The navigable instruments are equipped with a dimensional feature that allows connection to Medtronic's NavLock Trackers. A Navigation Adapter is also available with dimensional features that allows the same instruments to Medtronic's SureTrak" II Universal Trackers. These instruments are compatible with Spineology's Fortress", Threshold" Threshold™ V2, and Palisade™ Pedicular Fixation Systems and Medtronic's StealthStation® S7 (v2.1.0) and S8 (v1.0.0) Spine System.
Spineology Navigation Instruments for Portal Placement include a Dilator, Portal, Tightener, Wrench, and a Portal Surrogate. The navigable instruments are equipped with dimensional features that allow connection to Medtronic's SureTrak II Universal Trackers. These instruments are compatible with Spineology's OptiMesh Expandable Interbody Fusion System for Access Portal Placement and Medtronic's StealthStation® S8 (v1.2.0) Spine System.
Spineology Navigation Instruments are intended to be used during the preparation and placement of spinal implants in optically navigated procedures.
This document (K213876) is a 510(k) premarket notification for Spineology Navigation Instruments. While it describes non-clinical testing performed to establish substantial equivalence to a predicate device, it does not detail a clinical study with an AI component or the specific acceptance criteria and performance data for an AI-powered device.
The document discusses "Spineology Navigation Instruments" which are physical surgical tools used for navigation during spinal surgery. The testing described (mating, registration, accuracy) relates to the mechanical and optical tracking performance of these instruments when used with Medtronic's StealthStation system, not the performance of an AI algorithm.
Therefore, I cannot extract the information required to answer your prompt because the provided input does not describe an AI/ML-based medical device.
**To answer your prompt, I would need a document describing the clearance/approval of an AI/ML device, ideally one that includes: **
- Specific performance metrics (e.g., sensitivity, specificity, AUC) for the AI model.
- Details about the datasets used (training and test sets, including provenance and size).
- Information on ground truth establishment (expert review, pathology, etc.).
- If applicable, details of MRMC studies or human-in-the-loop performance.
Without such information, any attempt to answer would be speculative and not based on the provided document.
§ 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).