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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.

Other "performance testing" mentioned includes:

• CAD Model Evaluation: Verified that CAD models are accurately reflected in the application software. (No quantitative acceptance criteria or reported performance given beyond "verified").
• Formative Usability: Confirmed users can follow the navigated workflow and assemble the device. (No quantitative acceptance criteria or reported performance given beyond "confirmed").
• Summative Testing: Confirmed users can safely and effectively use the Stealth-Midas MR8 navigated drill handpiece with the StealthStation S8 software. (No quantitative acceptance criteria or reported performance given beyond "confirmed").

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided document. The document refers to "Accuracy validation testing" but does not detail the number of tests performed or the nature of the samples (e.g., phantom, cadaver, pre-clinical/clinical data).
• Data Provenance: Not specified. It can be inferred that testing was conducted internally by Medtronic, but no country of origin or whether it was retrospective/prospective is mentioned.

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

• This information is not provided in the document. The accuracy testing refers to comparing the device's measured accuracy against a predicate device's established accuracy requirements. It's likely that "ground truth" for navigational accuracy pertains to physical measurements using precision instruments, not expert-derived labels.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided and is generally not applicable to the type of engineering/physical accuracy testing described for a surgical navigation system. Adjudication methods are typically used for establishing ground truth in image interpretation or clinical outcomes, which is not the primary focus of the performance tests detailed here.

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

• No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for AI-assisted diagnostic tools, not for a surgical drill and navigation system like the Stealth-Midas MR8. The device assists surgeons in locating anatomical structures, but it does not analyze images or provide diagnoses that human "readers" would interpret.

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

• The concept of "standalone performance" for an algorithm is not applicable in the context of this device. The Stealth-Midas MR8 System is an instrument that functions in conjunction with a human surgeon and the StealthStation S8 System. Its "performance" is inherently linked to its ability to accurately track and display the position of surgical tools relative to patient anatomy, as used by a human, rather than an independent algorithmic output. The "Navigational Accuracy Analysis" seems to be a form of standalone technical performance assessment of the navigation component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the "Navigational Accuracy Analysis" would likely be physical measurements from a highly accurate measurement system (e.g., optical tracking system with known fiducials, coordinate measuring machine) in a controlled laboratory setting, rather than expert consensus, pathology, or outcomes data. The document implies a technical performance measurement against established benchmarks, not a clinical outcome.

8. The sample size for the training set

• Not applicable / Not provided. The Stealth-Midas MR8 System is a mechanical and optical medical device, not an AI/ML system that requires a "training set" in the computational sense. The device's design and operating parameters are based on engineering principles and validated through testing, not machine learning.

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

• Not applicable / Not provided. As the device is not an AI/ML system, there is no "training set" or corresponding ground truth establishment process in the way it's understood for AI/ML.

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