(44 days)
Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images) providing confirmation of hardware placement.
Through the introduction of new styluses in this submission, the previously cleared Vital Navigation Taps and Reduction Driver (K191722) can be used with the existing Vital MIS PAT Handle (K203507) to allow the user to navigate while using the PAT or PASIT assembly. It is important to note that these styluses will not be navigated. As such, the toolcard for the NavLock taps or NavLock driver will not change with this new use scenario.
The provided text describes the regulatory clearance of the Vital Navigation System (K213720) and highlights its substantial equivalence to predicate devices. However, it does not contain a detailed study proving that the device meets specific acceptance criteria in the manner requested (e.g., a comparative effectiveness study with human readers, standalone algorithm performance, or a specific test set with ground truth established by experts).
The document states: "Furthermore, accuracy testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the Navigated Instrument System which has been cleared for stereotactic guidance during orthopedic surgery procedures." This suggests that some form of accuracy testing was performed, but the specifics of this testing, including acceptance criteria, sample size, ground truth establishment, and expert involvement, are not detailed in the provided text.
Therefore, I cannot fulfill all parts of your request based on the provided input. I can, however, extract information about the device, its intended use, and the regulatory context.
Information that can be extracted from the provided text:
- Device Name: Vital Navigation System
- Intended Use/Indications for Use: Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Specifically designed for use with the Medtronic StealthStation System, which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
- Device Type: Stereotaxic Instrument (Class II)
- Regulatory Clearance: 510(k) clearance (K213720) based on substantial equivalence to predicate devices (Primary Predicate: Vital Navigation System K191722; Additional Predicates: Vital Spinal Fixation System K203507, Medtronic StealthStation System K133444).
- Nature of the Submission: A Special 510(k) due to the introduction of new styluses and techniques (navigated PAT/PASIT) for an existing cleared device.
Information NOT present in the provided text, rendering the requested table and study details incomplete:
- Acceptance Criteria Table: No specific acceptance criteria (e.g., accuracy metrics, precision targets) for the device's performance are provided.
- Reported Device Performance: No quantitative performance data (e.g., mean accuracy, standard deviation, error rates) from actual testing is presented.
- Sample Size for Test Set: Not specified.
- Data Provenance (country, retrospective/prospective): Not specified.
- Number of Experts for Ground Truth: Not specified.
- Qualifications of Experts: Not specified.
- Adjudication Method: Not specified.
- MRMC Comparative Effectiveness Study: The document indicates a device for surgical assistance, not an AI for image reading; therefore, an MRMC study with human readers assisting AI or vice versa is not directly applicable in the context of this device description. The text does not mention any study of this nature or effect sizes.
- Standalone Performance (algorithm only): Not applicable as this is a navigation system with physical instruments used in conjunction with a separate imaging system (Medtronic StealthStation), not a standalone AI algorithm.
- Type of Ground Truth Used: Not specified, beyond general "accuracy testing."
- Sample Size for Training Set: Not applicable/specified for this type of device (not an AI/ML algorithm that requires a training set in the conventional sense).
- How Ground Truth for Training Set was Established: Not applicable.
Given these limitations, I cannot construct the table or fully describe the study as requested. The provided document is a regulatory clearance letter and summary, not a technical report detailing the performance validation study.
§ 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).