(86 days)
The Navigated Taps and Screwdrivers are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and 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 the 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.
The Navigated Taps and Screwdrivers are surgical instruments intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the StealthStation® System. The Navigated Taps and Screwdrivers attach to the Medtronic NavLock™ Tracker, which allows for optical tracking of the surgical instrument. They are designed for use with the Medtronic CD HORIZON® LEGACY™ and CD HORIZON® SOLERATM screw systems. As described in the instructions for use, the instruments may also be used with the Medtronic IPC® POWEREASE™ System and NIM-ECLIPSE® System.
The provided text describes the 510(k) summary for Medtronic Navigation's Navigated CD HORIZON® SOLERA™ Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance values. Instead, it lists the types of tests conducted and concludes that the devices are "substantially equivalent" to predicate devices. The "Discussion of the Performance Testing" section serves as an overview of the tests performed to ensure functionality and compatibility.
| Test | Description of Test | Reported Device Performance (Summary) |
|---|---|---|
| Accuracy | Tested navigated instrument accuracy in both 2D and 3D space. | Performed (Implied adequate for substantial equivalence) |
| Accelerated Life Functionality | Tested navigated instrument functionality after multiple reprocessing cycles (cleaning and sterilization), simulating environmental exposure under expected use conditions. | Performed (Implied adequate for substantial equivalence) |
| Simulated Use | Tested navigated instruments according to the user's needs and intended use. | Performed (Implied adequate for substantial equivalence) |
| Shipping | Tested navigated instruments after simulated shipping conditions. | Performed (Implied adequate for substantial equivalence) |
| CAD Model Testing | Verified that the CAD models are accurately reflected in the application software. | Verified (Implied accurate reflection) |
| Cleaning Verification | Verified that the product can be effectively cleaned using automated and manual methods. | Verified (Implied effective cleaning) |
| Spine Tools (Toolcards) | Verified that the Spine tools package has met the required interface needs of the spine application software. | Verified (Implied interface needs met) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific sample sizes for any of the performance tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish "ground truth" for the test set. The testing appears to be primarily engineering and functional validation.
4. Adjudication Method for the Test Set:
No adjudication method is described, as the testing focuses on device functionality and accuracy rather than interpretation by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. This device is a surgical instrument for navigation, not an imaging diagnostic tool, so an MRMC study with human readers assisting AI or vice versa would not be applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The device itself is a surgical instrument that is used with a navigation system (StealthStation® System). The performance testing described focuses on the instrument's functionality, accuracy, and compatibility. It is not an "algorithm only" device in the sense of AI diagnostics, and thus a standalone algorithm performance study as typically understood in AI/ML medical devices is not applicable or described. The accuracy testing would represent a standalone performance of the instrument's tracking capabilities.
7. Type of Ground Truth Used:
For the "Accuracy" test, the ground truth would likely be established through precise metrology equipment or highly accurate reference points against which the navigated instrument's reported position is compared. For other tests like "Accelerated Life Functionality" and "Simulated Use," the ground truth would be the expected functional behavior and structural integrity under specified conditions. The document does not explicitly state the specific methods or types of ground truth used for each test.
8. Sample Size for the Training Set:
This document describes a medical device (surgical tools) and not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable to the information provided.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a training set is not applicable to this device submission.
§ 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).