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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws 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 (V1.2.0), 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 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 add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with additional CoreLink pedicle screws.

The provided text describes a 510(k) summary for CoreLink Navigation Instruments. This document does not contain information about an AI/ML powered device, but rather a set of non-sterile, reusable manual surgical instruments designed to interface with a navigation system. As such, the specific criteria requested for AI/ML powered devices, such as performance metrics like ROC curves, sensitivity, specificity, and detailed study designs involving AI performance, are not applicable here.

However, I can extract information related to the performance evaluation of the CoreLink Navigation Instruments based on the provided text.

Here's an analysis of the available information regarding acceptance criteria and performance:

1. A table of acceptance criteria and the reported device performance

The document mentions "Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments". It also states that "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."

However, the specific acceptance criteria (e.g., a defined threshold for positional accuracy) and the quantitative reported device performance values are not explicitly stated in this summary. It only indicates that testing per a standard was conducted and an engineering analysis confirmed representativeness.

2. Sample size used for the test set and the data provenance

The document refers to "Performance testing per ASTM F2554". ASTM F2554 is a standard for "Standard Test Method for Positional Accuracy of Computer-Assisted Surgical Systems." This standard outlines methods for testing, but the specific sample size (e.g., number of tests, number of instruments tested) used in the CoreLink study is not provided in this summary.

Similarly, the data provenance (e.g., country of origin, retrospective/prospective) related to this performance testing is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is geared towards AI/ML device evaluations where expert consensus often establishes ground truth for image interpretation or diagnosis. For a surgical instrument like the CoreLink Navigation Instruments, "ground truth" would typically relate to physical measurements of accuracy. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not directly applicable. The ground truth would be established by the measurement methods defined in ASTM F2554, likely involving precision measurement instruments and qualified test operators, but specifics are not provided.

4. Adjudication method for the test set

Similarly, adjudication methods (like 2+1 or 3+1) are common in studies where multiple human readers assess medical data for diagnostic agreement. For performance testing of a physical instrument's accuracy, a formal adjudication method among experts is not typically used. The "ground truth" is based on the precision of the measurement system itself. Details of any such process are not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is relevant for evaluating the impact of an AI system on human diagnosticians. Since the CoreLink Navigation Instruments are physical surgical tools and not an AI diagnostic system, an MRMC comparative effectiveness study in the context of "human readers improve with AI" is not applicable. The device aids surgeons in locating anatomical structures in spinal surgery with the Medtronic StealthStation® System, not in diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is also specific to AI/ML software. The CoreLink Navigation Instruments are physical instruments. Therefore, a standalone performance evaluation of an "algorithm only" is not applicable.

7. The type of ground truth used

As mentioned in point 3, for physical surgical instruments, ground truth for performance testing (e.g., positional accuracy) would typically be established through highly accurate physical measurement systems and methodologies, often prescribed by standards like ASTM F2554. This is distinct from "expert consensus, pathology, or outcomes data" which are common for diagnostic AI/ML systems. The specific type of ground truth measurement system used is not detailed beyond reference to ASTM F2554.

8. The sample size for the training set

This question refers to the training of an AI/ML model. Since the CoreLink Navigation Instruments are physical surgical tools and not an AI system, there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

As there is no training set for this device, how its ground truth was established is not applicable.

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