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The indications for use for the Imageless Knee Module for the StealthStation® System are identical to the StealthStation® System indications for use. The indications for use are as follows:

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

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 Hiosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

This submission describes updates made to the StealthStation® System to include software algorithms that enable the establishment of stereotactic coordinates without the use of preoperative or intra-operative image datasets.

This document is a 510(k) premarket notification for a device modification, specifically the "Imageless Knee Module for the StealthStation® System." The document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices. The listed sections primarily cover:

• Manufacturing and Contact Information
• Product Name and Classification
• Date Summary Submitted
• Description of Device Modification: The key change is software algorithms to establish stereotactic coordinates without preoperative or intra-operative image datasets, which was previously required for the predicate device.
• Substantial Equivalence: This section explicitly states, "The Imageless Knee Module for the StealthStation® System was shown to be substantially equivalent to the StealthStation System cleared in previous 510(k)'s. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This means the manufacturer believes the new software does not raise new questions of safety or effectiveness compared to the predicate.
• Indications for Use: These are identical to the predicate device.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth, expert qualifications, or MRMC studies. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

If you are looking for this type of information, it would typically be found in a separate performance study report or verification and validation documentation, which is generally not included in the public 510(k) summary provided by the FDA.

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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

ENT Procedures:

Transphenoidal procedures Intranasal procedures Orbital 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 Orthopedic Procedures:

pedicle screw placement.

Spinal Procedures:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal implant procedures, such as

This submission describes a modification to the StealthStation® System FluoroNav™ III. Module to provide for image guided knee surgery and orthopedic indications.

The provided text is a summary of safety and effectiveness for the Knee Module for the StealthStation® System, focusing on its substantial equivalence to predicate devices rather than a detailed study report with specific acceptance criteria or performance metrics. Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria or detailed performance metrics from a study. It states that "Performance data was provided to support the claim of substantial equivalence," but the data itself is not presented.

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

This information is not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided text.

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

This information is not available in the provided text.

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

This is a navigation system for surgery, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable in this context. The document does not mention any studies in this vein.

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

The device is a "Knee Module for the StealthStation® System," described as an "aid for precisely locating anatomical structures in either open or percutaneous procedures." This strongly implies human-in-the-loop performance during surgical navigation. The document does not describe a standalone performance study of an algorithm without human interaction.

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

This information is not available in the provided text. For a surgical navigation system, "ground truth" would typically relate to the accuracy of anatomical localization compared to actual anatomical structures, but the method of establishing this is not detailed here.

8. The sample size for the training set

This information is not available in the provided text.

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

This information is not available in the provided text.

In summary, the provided document focuses on the regulatory submission and FDA's determination of substantial equivalence for the Knee Module for the StealthStation® System. It does not contain the detailed study information regarding acceptance criteria, performance data, sample sizes, or ground truth establishment that would typically be found in a comprehensive clinical study report.

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