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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
Pituitary Tumor Removal
CSF Leak Repair
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement

ENT Procedures:
Transphenoidal Procedures
Intranasal Procedures
Orbital Nerve Decompression Procedures
Optic Nerve Decompression Procedures
Polyposis Procedures
Endoscopic Dacryocystorhinostomy
Encephalocele Procedures
Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw Placement

Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
Tumor Resection and Bone/Joint Reconstruction
Femoral Revision
Placement of Iliosacral Screws
Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

This submission describes updates made to the StealthStation® System to include software algorithms that facilitates a different registration method.

Acceptance Criteria and Study for StealthStation® System Advanced Contour Registration Software Module

Unfortunately, the provided document {0} - {4} does not contain information related to specific acceptance criteria or an explicit study proving the device meets particular performance metrics. The document is a 510(k) summary for the StealthStation® System Advanced Contour Registration Software Module, focusing on its substantial equivalence to a predicate device and its indications for use.

It primarily states: "As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." While this confirms that some form of testing was done, the specifics of those tests, including quantitative acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert involvement, are not detailed in this summary.

Therefore, I cannot populate the requested table and answer many of the questions directly. The information below reflects what can be inferred or is explicitly stated within the provided text, along with the acknowledgement of missing crucial details.

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative performance metrics are provided in the document. The document only states that "verification and validation activities were performed... and the results demonstrated substantial equivalence."

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

Not specified in the provided document. The document mentions "verification and validation activities" but does not detail the sample sizes for any test sets used, nor the provenance (country of origin, retrospective/prospective) of any data used for testing.

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

Not specified in the provided document. The document does not mention the use of experts for establishing ground truth or their qualifications.

4. Adjudication method for the test set

Not specified in the provided document. No details are provided regarding any adjudication methods used for a test set.

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 specified and highly unlikely for this type of device and submission. The provided document is a 510(k) summary for a software module facilitating a different registration method for a stereotactic navigation system. It does not describe an AI system, nor does it mention any MRMC study comparing human performance with and without the device. The focus is on the device's ability to aid in precise anatomical localization during surgery.

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

Not explicitly described. The device is a "software module" for a "StealthStation® System," described as "an aid for precisely locating anatomical structures in either open or percutaneous procedures." This implies human-in-the-loop use. While the algorithm itself would have been tested in a standalone fashion for its function, the document does not distinguish between standalone algorithm testing and system-level performance. The testing for "substantial equivalence" would have focused on the full system's performance, which is inherently with a human operator.

7. The type of ground truth used

Not specified in the provided document. The document does not provide details on how ground truth was established for any verification or validation activities. For a stereotactic system, common ground truths might involve physical measurements against known phantoms, cadaver studies with implanted markers, or intraoperative imaging correlations, but none are mentioned here.

8. The sample size for the training set

Not applicable/Not specified. The document describes a "software module that facilitates a different registration method" and focuses on "substantial equivalence." There is no indication that this device uses machine learning or requires a "training set" in the modern sense of AI/ML. The "verification and validation activities" would likely involve testing the software's functionality and accuracy, not training an algorithm.

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

Not applicable/Not specified, as no training set is indicated.

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