(30 days)
CoreLink Navigation Instruments is indicated for use during the preparation and placement of Siber Ti Sacroiliac Joint Fusion System implants and Entasis Dual-Lead Sacroiliac Implant System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation S8 System (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.
The purpose of this submission is to offer compatibility of the previously cleared CoreLink Navigation Instruments for sacroiliac fusion implants with additional CoreLink Sacroiliac Screws and to update the sacroiliac navigation instrument set.
The provided text describes a 510(k) premarket notification for the CoreLink Navigation Instruments. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/ML-driven device.
This document is a regulatory submission for a manual surgical instrument (CoreLink Navigation Instruments) designed to assist in locating anatomical structures during spinal surgery, used in conjunction with a separate navigation system (Medtronic StealthStation S8 System). It's not a submission for an AI/ML-driven device that would typically involve acceptance criteria related to algorithmic performance (e.g., sensitivity, specificity, F1-score), ground truth establishment by experts, or MRMC studies.
Therefore, I cannot extract the information asked for in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, etc.) from the given text.
The closest information provided is:
- Device Type: Non-sterile, re-usable manual surgical instruments.
- Purpose: To assist surgeons in precisely locating anatomical structures.
- Performance Data: "Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments as submitted under previous submissions of the CoreLink Navigation Instruments (K212825). An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments."
This indicates that the "performance" here refers to the physical and mechanical accuracy of the manual instruments, not the diagnostic or predictive performance of an AI model.
To answer your questions, I would need a different type of document, specifically one that describes a clinical or technical validation study 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).