(70 days)
The AnyPlus Navigated Instrument System is indicated for the preparation and placement of the Poly-Axial Screws of the AnyPlus Spinal Fixation System during a navigated thoracolumbar fusion procedure to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. This system is intended to be used in conjunction 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The use of the AnyPlus Navigated Instrument system is limited to use only with the AnyPlus Spinal Fixation System.
The subject device, AnyPlus Navigated Instrument System, includes Taps and a Driver that are compatible with the Medtronic StealthStation® S7 Navigation System. The subject, AnyPlus Navigated Instruments (Taps and Driver), is used to place the GS Medical's AnyPlus Spinal Fixation pedicle screws (Poly-Axial Screws) during a navigated thoracolumbar fusion procedure. These instruments include a regular driver for AnyPlus pedicle screws and multiple taps ranging from 4.5mm to 8.5mm in diameter, increasing by increments of 0.5mm.
These Navigated Instruments are supplied non-sterile, reusable, and fabricated from UNS S45500 Precipitation-Hardened Stainless Steel in accordance with ASTM F899.
This 510(k) summary describes the AnyPlus Navigated Instrument System, a device for spinal surgery. The information provided is sufficient to answer the request.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Recognition and Location with Medtronic StealthStation® Navigation System | Passed: Both the subject device (AnyPlus Navigated Instrument system Driver and Tap) and the additional predicate device (Navigated CD HORIZON® SOLERA® Driver and Tap) passed recognition and location testing with the Medtronic StealthStation® navigation system. |
| Dimensional Accuracy (Critical Length) | Within Tolerance: Subject device and additional predicate Driver and Tap were compared for dimensional accuracy, and the critical length measurements are within the tolerance limit. The text specifies a "+/-0.15mm difference in tolerance," and states that this "minor difference... does not raise new questions of safety and effectiveness." |
| Successful Registration and Placement of AnyPlus Pedicle Screws | Successfully Achieved: Performance testing proves that the subject device Taps and driver successfully register and place the AnyPlus pedicle screws with the help of the Medtronic Stealth Station System, performing the same as the additional predicate. |
| Compatibility with Medtronic StealthStation® System | The subject device includes Taps and a Driver that are explicitly stated to be compatible with the Medtronic StealthStation® S7 Navigation System. The performance testing confirmed this compatibility, as the devices "passed recognition and location testing with the Medtronic StealthStation® navigation system" and "successfully register and place the AnyPlus pedicle screws with the help of the Medtronic Stealth Station System." |
| Material Identity to Primary Predicate | Identical: The material (UNS S45500 Precipitation-Hardened Stainless Steel in accordance with ASTM F899) and manufacturing process of the subject device (AnyPlus Navigated Instruments) are identical to the primary predicate (Anyplus Spinal Fixation Systems Drivers and taps, K091717). |
| Technological Characteristics and Principle of Operation to Primary Predicate | Identical: The subject device (AnyPlus Navigated Instrument system) and the Primary Predicate (AnyPlus Spinal Fixation System, K091717) have identical material, the same technological characteristics, and the principle of operation (to implant an AnyPlus Screw). |
| Indications for Use/Intended Use Equivalence to Additional Predicate | Identical: The subject device (AnyPlus Navigated Instrument) and the additional predicate (Navigated CD Horizon Solera Screwdrivers and Taps, K140454) have identical indications for use/intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the specific data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance testing" and "recognition and location testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. The testing appears to be primarily technical and performance-based against a navigation system and a predicate device.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method like 2+1, 3+1, or none. The testing described focuses on device performance and compatibility rather than subjective interpretation by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This device is a navigated instrument system for spinal surgery, not an AI-assisted diagnostic or imaging interpretation tool that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not performed according to the provided information.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This device is an instrument system used in conjunction with a navigation system (Medtronic StealthStation® System) and operated by a surgeon. It is not an algorithm that performs autonomously or 'standalone' in a diagnostic sense. The testing described is about the standalone performance of the instruments (Taps and Driver) in interacting correctly with the navigation system. The "algorithm" here would be the navigation system's own algorithms, which are not the subject device. The performance data focuses on the navigational instruments' ability to be recognized, located, and successfully used for screw placement.
7. The Type of Ground Truth Used
The ground truth used for this type of device is primarily physical and functional performance metrics. This includes:
- Dimensional Accuracy: Comparing the critical lengths of the subject device to the predicate device within specified tolerances.
- System Recognition and Location: Confirming that the navigation system correctly identifies and tracks the instruments.
- Successful Mechanical Interaction: Verifying that the instruments can successfully prepare and place pedicle screws.
- Material and Technological Identity: Confirming that the subject device matches the primary predicate in these fundamental aspects.
It is not based on expert consensus, pathology, or outcomes data in the traditional sense, as these are instruments, not diagnostic tools.
8. The Sample Size for the Training Set
This document describes a medical instrument, not a machine learning or AI algorithm that requires a "training set" in the context of data. Therefore, the concept of a training set sample size is not applicable to this device.
9. How the Ground Truth for the Training Set was Established
As the concept of a "training set" is not applicable, this question is also not relevant to the information provided for this device.
§ 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).