(40 days)
CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) 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® System S8 (V1.2.20), 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 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. 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 clear the CoreLink Navigation Instruments for use with additional versions of the StealthStation software and to add instruments to the previously cleared CoreLink Navigation Instruments set.
This is a 510(k) premarket notification for CoreLink Navigation Instruments.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "confirmatory positional accuracy testing per ASTM F2554" but does not explicitly state the acceptance criteria (e.g., a specific tolerance in mm) or the numerical results of this performance testing. It only states that the testing was done to "demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use."
| Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Positional Accuracy per ASTM F2554 (Specific metric not provided) | Adequately and substantially equivalent accuracy for intended use (Specific numerical results not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the positional accuracy testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described focuses on device performance against a standard (ASTM F2554) rather than human expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't explicitly described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. The document describes testing of the navigation instruments' accuracy, not a study comparing human reader performance with and without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone study of the device's performance was done. The document states that CoreLink, LLC "conducted confirmatory positional accuracy testing per ASTM F2554 with Medtronic StealthStation® System S8 Version 1.2.0 (1.2.0-20)." This refers to testing the device itself for accuracy, independent of a human surgeon's interaction in a clinical setting for the purpose of this particular performance data section.
7. The Type of Ground Truth Used
The ground truth for the positional accuracy testing would be established by the specifications and methodology of ASTM F2554, which defines how to measure and assess the accuracy of navigated surgical instruments. This standard typically involves objective measurements against a known reference or ideal position, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This device is a set of manual surgical instruments that interface with a navigation system, not an AI or machine learning algorithm that requires a training set in the conventional sense. Therefore, the concept of a "training set" is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As explained above, a training set is not applicable for this type of 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).