(47 days)
This submission does not change the indications for use for the StealthStation System.
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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
For the optical-based and EM-based system, 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
Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty
Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw 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
Additional example procedures for the optical-based system include, but are not limited to:
Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty, Minimally Invasive Orthopaedic Procedures, Pediatric Orthopaedics, Total Hip Replacement (Primary and Revision), Periacetabular Osteotomies, 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)
Modification to the StealthStation® System to allow for the use of a wireless Bluetooth mouse.
This submission describes the StealthStation® Wireless Surgeon Mouse, a modification to the existing StealthStation® System to allow for the use of a wireless Bluetooth mouse. The 510(k) summary does not include detailed acceptance criteria or a dedicated study proving the device meets specific performance metrics in the way one might expect for a diagnostic or AI device. Instead, the focus is on demonstrating "substantial equivalence" to a legally marketed predicate device through risk analysis and verification/validation activities.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance for StealthStation® Wireless Surgeon Mouse
The provided document does not specify quantitative acceptance criteria for the StealthStation® Wireless Surgeon Mouse. Instead, it relies on demonstrating substantial equivalence to a predicate device through risk analysis and verification/validation activities. The core claim is that the modification (the addition of a wireless mouse) does not change the indications for use or the fundamental safety and effectiveness of the existing StealthStation® System.
Therefore, the "acceptance criteria" can be inferred as:
- Maintaining the safety and effectiveness of the predicate device.
- Not introducing new safety concerns or raising new questions of effectiveness.
- The wireless mouse functionality performs as expected within the integrated system.
No specific device performance metrics (e.g., accuracy, precision, latency) are reported in this summary.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| No new safety concerns introduced. | Verified through risk analysis and verification/validation activities. |
| No new questions of effectiveness raised. | Verified through risk analysis and verification/validation activities. |
| Wireless mouse functions as intended within the StealthStation® System. | Verified through risk analysis and verification/validation activities. |
| Clinical indications for use remain unchanged. | Explicitly stated: "This submission does not change the indications for use for the StealthStation System." |
Study Details (Based on available information in the 510(k) summary)
The document refers to "all verification and validation activities were performed by required by risk analysis, and the results demonstrated the substantial equivalence." However, it does not provide details about a specific clinical study or technical performance study in the traditional sense, particularly not one involving AI or diagnostic performance metrics.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The document outlines a regulatory submission process based on risk analysis and verification/validation, rather than a clinical trial with a specific data set. The evaluation is for a device modification (adding a wireless mouse) to an existing, cleared system.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a 510(k) submission for a device modification (wireless mouse), not a diagnostic or AI device requiring expert-established ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is relevant for studies involving human interpretation or diagnostic accuracy assessments, which are not detailed in this submission.
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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 reported. This device is not an AI diagnostic tool and does not involve human readers in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done or reported. This device is a hardware accessory (wireless mouse) for an existing surgical navigation system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Ground truth" as typically defined for diagnostic or AI studies is not applicable here. The "truth" for this device modification would relate to the functional operation of the wireless mouse and its integration into the StealthStation® System, ensuring it performs its intended control functions reliably and safely without degrading the core system's performance.
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The sample size for the training set:
- Not applicable. This device is a hardware accessory and not an AI or machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).