(30 days)
Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.
The CD HORIZON™ Spinal System surgical instruments are non-sterile, single or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.
The CD Horizon™ instruments are intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connect ion site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the instrument dimensions have been designed to work with the MAZOR X arm guides. The subject taps and drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011). The instruments will be provided non-sterile and are reusable.
The provided document is a 510(k) summary for the Medtronic CD Horizon Spinal System. It does not include information about a study proving the device meets specific acceptance criteria in the way a clinical study would for an AI/algorithm-driven medical device.
This document describes a new version of surgical instruments, designed to be compatible with existing navigation and robotic systems (MAZOR X Stealth™ Edition, IPC™ POWEREASE™ System, and NavLock™ trackers). The "performance data" section refers to engineering verification testing rather than a clinical study evaluating diagnostic or therapeutic accuracy against human performance. The device itself is a set of surgical instruments, not an AI algorithm.
Therefore, I cannot extract the requested information (acceptance criteria, sample size, expert ground truth, MRMC study, standalone performance, etc.) from this document because it is not relevant to the type of device and study requested in the prompt.
The "Performance Data" table provided in the document refers to engineering and functional testing of the instruments, such as:
- Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
- Anatomical Simulated Use: Confirmed instrument functionality under expected use conditions.
- Navigation Simulated Use: Confirmed navigation system functionality under expected use conditions.
- CAD Model Evaluation: Verified that the CAD models are accurately reflected in the application software.
- Navigation Software Module Instrument Functional Testing: Verified that the instrument attributes are correctly implemented in the navigation software module.
These are design verification and validation activities for a physical instrument, not a study evaluating the performance of an AI algorithm or a diagnostic tool against human ground truth.
§ 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).