(72 days)
The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous 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 a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
The Stealth-Midas System consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation with the StealthStation System. The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable.
The document provided describes the Stealth-Midas System, a medical device intended for spinal surgical procedures, and lists some performance testing. However, it does not contain the requested detailed acceptance criteria or a comprehensive study report with specific performance metrics such as sensitivity, specificity, or reader improvement. The information available is limited to a summary of performance testing and a declaration of substantial equivalence to predicate devices.
Based on the provided text, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (Based on available information):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Navigation Accuracy | Confirmed navigated instrument accuracy |
| CAD Model Evaluation | Verified that the CAD models are accurately reflected in the application software |
| Formative Usability | Confirmed users can follow the navigated workflow and assemble the device |
| Substantial Equivalence | Demonstrated through comparison and testing against identified predicate devices (Midas Rex Electric Surgical Drill/Saw System (K081475), Midas Rex MR7 Pneumatic High Speed System (K090112), Navigated VERTEX SELECT® Instruments (K143628)). Specific metrics not detailed. |
Missing Information/Not Provided in the Document:
-
Detailed Acceptance Criteria and Specific Performance Results: While categories of testing are mentioned, the document lacks specific quantitative acceptance criteria (e.g., "accuracy must be within X mm") and the exact numerical results obtained from the tests. For example, for "Navigation Accuracy Analysis," it only states "Confirmed navigated instrument accuracy," without providing the actual accuracy achieved.
-
Sample Size used for the test set and data provenance: The document mentions "testing was completed" but does not specify the sample size for any of the tests (e.g., number of instruments tested for navigation accuracy, number of users for usability, number of cases/models for CAD evaluation). It also does not mention data provenance (e.g., country of origin, retrospective or prospective nature).
-
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
-
Adjudication method for the test set: Not mentioned.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was conducted, nor is there any mention of an effect size for human reader improvement with or without AI assistance. The device is a navigated surgical instrument, not an AI-assisted diagnostic tool, so such a study would likely not be relevant or performed in this context.
-
Standalone Performance: The document does not describe a "standalone (i.e., algorithm only without human-in-the-loop performance)" study. The device is described as an aid for surgery, implying human interaction.
-
Type of ground truth used: For the navigation accuracy, the ground truth would likely be a precisely measured physical reference. For CAD model evaluation, the ground truth would be the original CAD models. For usability, the ground truth would be successful task completion and user feedback against predefined usability goals. These are not explicitly detailed in the document.
-
Sample size for the training set: The document does not refer to any AI/ML models that would require a "training set." The device described is a navigated surgical instrument, not an AI-driven diagnostic or predictive system in the context of what would typically have a "training set" of data.
-
How the ground truth for the training set was established: Not applicable, as no training set for an AI/ML model is indicated.
Summary of the Study (Based on available information):
The document refers to "Performance Testing" which was "completed to ensure the functionality and compatibility with the identified Medtronic products." This testing primarily focused on:
- Navigation Accuracy Analysis: To confirm that the addition of the passive optical tracker to the drill handpieces resulted in accurate navigation of the instruments. The document states, "Navigational accuracy testing confirms that the subject navigated drill system is as accurate as the predicate navigated Vertex Select instruments."
- CAD Model Evaluation: To verify that the CAD models used by the application software accurately reflected the physical design.
- Formative Usability: To confirm that users could effectively follow the navigated workflow and properly assemble the device.
The overall conclusion drawn from this testing and comparison was that the "Stealth-Midas System has been shown through comparison and testing to be substantially equivalent to the identified predicate devices." This implies that the performance results met the standards set by the predicate devices, though specific quantitative measures are not provided.
§ 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).