(28 days)
The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 the spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:
o Pedicle Screw Placement
- o Iliosacral Screw Placement
o Interbody Device Placement
The StealthStation System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments and a referencing system. The IGS tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The StealthStation Spine software helps guide surgeons during spine procedures such as spinal fusion and trauma treatments. StealthStation Spine Software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
Based on the provided text, the acceptance criteria and study proving the device meets these criteria for the StealthStation S8 Spine Software v1.3.0 can be summarized as follows:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (System Accuracy Requirements) | Reported Device Performance (StealthStation S8 Spine Software v1.3.0) |
|---|---|
| Mean positional error ≤ 2.0 mm | Worst-case Configuration: Mean positional error of ≤ 2.0 mm |
| StealthAiR Spine (Specific feature): Positional Error – 1.01 mm | |
| Overlapping Slices (Specific feature): Positional Error – 0.51 mm | |
| Mean trajectory error ≤ 2 degrees | Worst-case Configuration: Mean trajectory error of ≤ 2 degrees |
| StealthAiR Spine (Specific feature): Trajectory Error – 0.37 degrees | |
| Overlapping Slices (Specific feature): Trajectory Error – 0.41 degrees |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the test set used for the accuracy performance. It mentions "anatomically representative phantoms" were used.
- Data Provenance: The study was conducted using "anatomically representative phantoms." The country of origin of the data is not specified, but the applicant company is Medtronic Navigation, Inc., located in Louisville, Colorado, USA. The study design is implied to be prospective testing on phantoms rather than retrospective patient data.
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 was performed on phantoms, which typically rely on engineered and measurable ground truth, not expert consensus on anatomical structures or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document, as the ground truth for phantom testing is typically established by the design of the phantom and measurement techniques, not human adjudication.
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 mentioned. The device, StealthStation S8 Spine Software, is an image-guided surgery system, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies comparing human reader performance. The software aids surgeons in precisely locating anatomical structures.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device's performance was evaluated in terms of its ability to measure positional and trajectory accuracy on phantoms. This can be considered a form of standalone performance assessment as it evaluates the system's inherent accuracy capabilities, albeit in a simulated (phantom) environment, without directly measuring human-in-the-loop clinical workflow improvement. The text refers to "System integration performance testing for spine surgical procedures using anatomical phantoms."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established by the design and measurement capabilities of the "anatomically representative phantoms." This type of ground truth is based on precise, engineered physical properties and known measurements of the phantom. It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This information is not provided in the document. The document describes a software update (v1.3.0) to an existing device, and the focus of the 510(k) summary is on performance testing for substantial equivalence, not on the training data used for the algorithm's development.
9. How the ground truth for the training set was established:
This information is not provided in the document. As this document is a 510(k) summary for a software update, details about the original model training and ground truth establishment are typically not included unless significant changes related to the algorithm's core functionality or AI components are introduced which necessitate new data for training or re-training.
§ 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).