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The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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 long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

The Stealth-Midas MR8 consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation in conjunction with the StealthStation S8 System and the Integrated Power Console (IPC). The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable. The associated attachments are provided non-sterile and are reusable. The associated surgical dissecting tools and MR8 ClearView burs are provided sterile and are single-use.

This document describes the premarket notification (510(k)) for the Medtronic Stealth-Midas MR8 System. The information provided outlines the device, its intended use, and comparative testing to establish substantial equivalence to predicate devices. However, the document does NOT contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in the format requested. The document primarily focuses on establishing substantial equivalence based on technological characteristics and functional testing, not a formal clinical efficacy or diagnostic performance study with specific quantitative acceptance criteria typically seen for AI/ML-driven devices.

Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, standalone performance, type of ground truth) are not explicitly present in the provided text. The device described is a surgical instrument with navigation capabilities, not an AI/ML-driven diagnostic or prognostic tool.

Despite this, I will describe what is present and indicate what is missing based on the prompt's requirements.

Device Name: Stealth-Midas MR8 System
Device Type: Stereotaxic Instrument (Surgical Navigation System with Drill)

The provided document describes the Stealth-Midas MR8 System, which combines an electric and pneumatic drill handpiece with an optical navigation tracker for computer-assisted surgery. The purpose of the 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove the device meets specific quantitative performance acceptance criteria in the context of an efficacy study as might be conducted for an AI/ML diagnostic algorithm.

Here's a breakdown of the requested information based on the provided document:

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

The document focuses on "Navigational Accuracy Analysis" as a key performance test.

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