(52 days)
Medtronic Navigated 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 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 Instruments are also compatible with the IPC® POWEREASE™ System.
The Navigated VERTEX SELECT® Instruments are both non-sterile, reusable and sterile, single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the VERTEX® Reconstruction System. The Navigated VERTEX SELECT® Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.
The provided text describes the 510(k) premarket notification for the "Navigated VERTEX SELECT® Instruments." This document outlines the device's characteristics, its indications for use, and a summary of performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" with specific numerical thresholds for each test. Instead, it describes the purpose of each test and implies successful completion, indicating the device met the intended functional and compatibility requirements.
| Test | Description | Reported Device Performance (Implied) |
|---|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy | The test was "completed to ensure the functionality and compatibility." It is implied that the instrument's accuracy, when navigated, was confirmed to be acceptable. |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions | The test confirmed "instrument functionality under expected use conditions." This suggests the instruments performed as intended in a simulated anatomical environment. |
| Navigation Simulated Use | Confirmed navigation system functionality under expected use conditions | The test confirmed "navigation system functionality under expected use conditions." This indicates the device's interaction with the navigation system (StealthStation®) was successful. |
| CAD Model Evaluation | Verified that the CAD models are accurately reflected in the application software | The evaluation "verified that the CAD models are accurately reflected in the application software." This ensures the virtual representation matches the physical design for navigation. |
| Implant/Instrument Mating | Verified that the instruments can be assembled with the appropriate devices according to their intended use | The test "verified that the instruments can be assembled with the appropriate devices according to their intended use." This confirms proper fit and function with the VERTEX® Reconstruction System screws. |
| Spine Tools Package Functional Testing | Verified that the Spine Tools package has met the required interface needs of the spine application software | The testing "verified that the Spine Tools package has met the required interface needs of the spine application software." This ensures software compatibility and proper integration within the surgical navigation platform. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for any of the tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of data). The testing appears to be in-house, pre-market validation conducted by Medtronic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given the nature of the tests (functional and compatibility), ground truth would likely be established through engineering specifications, design requirements, and direct observation by qualified test personnel.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method for the test set. The tests appear to be pass/fail based on predetermined criteria (e.g., "confirmed accuracy," "verified functionality").
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this device. The Navigated VERTEX SELECT® Instruments are surgical tools designed for precision during spinal surgery, not an AI-assisted diagnostic or interpretative system for human readers. Therefore, there's no "human reader" component to measure improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of "standalone performance" (algorithm only) is not applicable to this device in the same way it would be for an AI diagnostic tool. The device is a physical instrument intended for use with a navigation system (StealthStation®) controlled by a human surgeon. The "navigation accuracy analysis" and "navigation simulated use" tests assess the performance of the instrument in conjunction with the navigation system, which is a form of integrated performance rather than a standalone algorithm.
7. The Type of Ground Truth Used:
The ground truth for these tests appears to be based on:
- Engineering Specifications and Design Requirements: For tests like "Navigation Accuracy Analysis," the ground truth would be the expected or designed level of accuracy for the navigated instruments.
- Intended Use Conditions: For "Anatomical Simulated Use" and "Navigation Simulated Use," the ground truth would be the defined functional performance under expected surgical scenarios.
- CAD Model Fidelity: For "CAD Model Evaluation," the ground truth is the actual design parameters of the CAD models.
- Assembly and Interface Specifications: For "Implant/Instrument Mating Conditions" and "Spine Tools Package Functional Testing," the ground truth is the specified fit, form, and function for mating and interface.
The ground truth is therefore primarily based on predetermined specifications and successful functional operation rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or prognostic devices.
8. The Sample Size for the Training Set:
The document does not mention a "training set" because this device is a physical surgical instrument and not an AI/machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this device (it's not an AI/ML product), this question is not applicable.
§ 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).