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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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 the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:

Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/Pallidotomies.

Spinal Procedures:

Spinal implant procedures, such as pedicle screw placement.

ENT Procedures:

Transphenoidal procedures. Intranasal procedures.

Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies./Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.

Not Found

The provided text is a 510(k) Summary for a device called the StealthStation® System, with a focus on an "Indications Modification." This document describes a change to the intended use of the device rather than a new device or significant technical modification. As such, it relies on previously submitted clinical data and the concept of substantial equivalence, rather than presenting new acceptance criteria or a specific study to prove new performance claims for this particular submission.

Therefore, many of the requested details about acceptance criteria and a new study are not present in this document, as this submission is for an indications modification based on existing data that supported previous clearances.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable or unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/provided. This submission is for an indications modification of an existing, cleared device (StealthStation® System). It does not present new performance data or acceptance criteria for a new device or a new performance claim. It relies on the substantial equivalence to previously cleared versions (K954276/K972398/K974187) and the clinical study data originally submitted for K954276.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "A review of clinical study data originally submitted in K954276 was provided to support the claim of substantial equivalence." Since this is a modification to indications for use based on previously submitted data, the details of the sample size and provenance for that original K954276 study are not provided in this specific 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the current document. It would have been part of the original K954276 submission.

4. Adjudication Method for the Test Set

This information is not provided in the current document. It would have been part of the original K954276 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable/provided. This document focuses on an indications modification based on prior clearance and data. There is no mention of a new MRMC comparative effectiveness study to assess human readers with or without AI assistance. The StealthStation is a navigation system, not an AI-assisted diagnostic tool as typically understood in the context of MRMC studies involving image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The StealthStation is a surgical navigation system, inherently designed for human-in-the-loop performance during surgical procedures. The concept of a "standalone" algorithm performance as typically applied to AI diagnostics is not relevant here.

7. Type of Ground Truth Used

The document mentions that the system aids in "precisely locating anatomical structures... relative to a CT or MR based model or fluoroscopy images of the anatomy." This implies that the ground truth for the original K954276 study would likely be the actual anatomical structures as confirmed by imaging (CT/MR/Fluoroscopy) or direct surgical observation. However, the specific methodology for establishing ground truth from the original study is not detailed in this summary.

8. Sample Size for the Training Set

Not applicable/provided. The StealthStation is a stereotactic instrument/navigation system. The concept of a "training set" as understood in machine learning for an AI-based diagnostic device is not directly applicable to this type of device based on the information provided. While there would have been internal validation during development, it wouldn't typically be described with a "training set" in the context of a 510(k) for an indications modification of a navigation device.

9. How the Ground Truth for the Training Set Was Established

Not applicable/provided for the reasons stated in point 8.

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