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The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are 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 long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system instruments. Current cleared Spineart® Navigation reusable instruments (K241644, K210472 & K183630) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's Brainlab® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the Brainlab® Spine & Trauma Navigation System to the cleared range of SPINEART® Navigation Instrument System.

The provided FDA 510(k) clearance letter describes the "SPINEART Navigation Instrument System." This document is a clearance letter and a 510(k) summary, which may not always detail the full extent of the testing that would typically be found in a full submission. However, based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document states: "Performance data showed the addition of the SPINEART Brainlab® Navigation Adaptor (Subject device) on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System, provides an accuracy at least equivalent to the initial intended use defined for Brainlab® and provides results in simulated use more accurate than the acceptance criteria."

However, specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text. The performance is reported as meeting or exceeding unspecified acceptance criteria.

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

The document does not specify the sample size used for the test set. It mentions "Comparison of accuracy between the Brainlab® tracker and clamps directly attached on the SPINEART Navigation Reusable Instruments and the Brainlab® tracker and clamps attached on the SPINEART Navigation Reusable Instrument using the SPINEART Brainlab® Navigation Adaptor (subject device)" and "Accuracy in simulated use (protocol adapted from ASTM F2554-22)."

The data provenance is not explicitly stated as originating from a specific country or as retrospective/prospective. The testing appears to be non-clinical performance bench testing conducted by the manufacturer, Spineart SA, located in Switzerland.

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

The document does not mention the use of experts or their qualifications for establishing ground truth in the non-clinical testing. The ground truth (or reference standard) in this type of accuracy testing is typically established through precise metrological instruments and methods.

4. Adjudication method for the test set

Not applicable. The described testing is non-clinical performance testing (bench testing for accuracy), not a study involving human interpretation that would typically require an adjudication method.

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

Not applicable. The device is a "Navigation Instrument System" intended to assist surgeons in precisely locating anatomical structures. It is not an AI-assisted diagnostic device that would typically involve human readers interpreting images, therefore, an MRMC study is not relevant to this device.

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

This device appears to be an instrument system and not an algorithm in the traditional sense of AI. The "standalone" performance tested was the accuracy of the navigation system components (specifically the new adapter with the instruments and Brainlab system), which is essentially the performance of the technical system without direct human variability in judgment as the primary outcome. The testing performed was a "Comparison of accuracy" and "Accuracy in simulated use," which are standalone technical evaluations.

7. The type of ground truth used

The ground truth for the accuracy testing would typically be established by highly precise measurement systems (e.g., coordinate measuring machines, optical tracking systems) that can determine the true position and orientation of instruments with sub-millimeter accuracy in a controlled testing environment. The document mentions "dimensional analysis" as also confirming accuracy.

8. The sample size for the training set

Not applicable. This device is not described as an AI/ML device that requires a training set. It is a navigation instrument system, and its performance is evaluated based on its mechanical and optical tracking accuracy.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

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