(87 days)
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.
The Navigated Screwdrivers and Taps are non-sterile, reusable surgical instruments that can be operated manually or under power. These instruments are intended to be used when implanting CD HORIZON® Spinal System devices. The Navigated Screwdrivers and Taps are also compatible with the StealthStation® and IPC® POWEREASE™ Systems.
The provided document does not contain detailed acceptance criteria or a study that extensively proves the device meets those criteria in a quantitative sense as typically seen with AI/ML-based medical devices. The submission concerns a set of navigated surgical instruments (screwdrivers and taps) and focuses on demonstrating substantial equivalence to predicate devices through functional and compatibility testing, rather than performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.
However, based on the provided text, I can extract the following information about the performance testing conducted and what it implies about "acceptance criteria" in this context:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy. | Confirmed navigated instrument accuracy. |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions. | Confirmed instrument functionality under expected use conditions. |
| Navigation Simulated Use | Confirmed navigation system functionality under expected use conditions. | Confirmed navigation system functionality under expected use conditions. |
| CAD Model Evaluation | Verified that the CAD models are accurately reflected in the application software. | Verified that the CAD models are accurately reflected in the application software. |
| Implant/Instrument Mating Conditions | Verified that the instruments can be assembled with appropriate devices according to their intended use. | Verified that the instruments can be assembled with the appropriate devices according to their intended use. |
| Spine Tools Package Functional Testing | Verified that the Spine Tools package has met the required interface needs of the spine application software. | Verified that the Spine Tools package has met the required interface needs of the spine application software. |
Explanation of "Acceptance Criteria (Implied)":
The document lists "Description" for each test, which states what the test confirmed or verified. In the absence of specific numerical thresholds or target metrics (e.g., "accuracy > 95%"), the implied acceptance criterion for each test is that the described functionality or characteristic was successfully demonstrated and met. For instance, for "Navigation Accuracy Analysis," the implied criterion is that the navigation accuracy was found to be acceptable for its intended surgical use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of instruments tested, number of simulated cases) for any of the performance tests. It also does not mention data provenance (country of origin, retrospective/prospective), as the testing appears to be primarily lab-based functional and compatibility testing of physical instruments, not data-driven evaluation of an AI algorithm on patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The tests described are primarily engineering validation tests for physical instruments and software integration, not clinical studies requiring expert-established ground truth on patient cases.
4. Adjudication Method
Not applicable, as this is not an evaluation of a system requiring human adjudication of results (e.g., diagnostic image interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a navigated surgical instrument, not a diagnostic AI system designed to improve human reader performance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a set of physical surgical instruments designed to work with a navigation system, not a standalone algorithm. The "Navigation Accuracy Analysis" and "Navigation Simulated Use" tests confirm the instrument's interface and functionality with the navigation system, not a standalone algorithm's performance.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, expert consensus) is not directly relevant here. The "ground truth" for these tests would be derived from engineering specifications, design requirements, and direct measurement of physical properties or system outputs to verify functionality and compatibility against established standards. For example, for "Navigation Accuracy Analysis," the ground truth would be precise measurements of instrument tip location compared to the reported navigated location.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no ground truth for it to be established.
§ 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).