(328 days)
The GX Navigation Instruments are intended to be used during the preparation and placement of Life Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARx Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System, Centerline Thoracolumbar Spinal System and Centric-T System.
The GX Navigation instruments are manufactured from Stainless Steel as specified in ASTM F899, non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use.
The provided FDA 510(k) summary for the GX Navigation Instrument System does not contain detailed information regarding acceptance criteria and a specific study proving the device meets those criteria in the context of AI/machine learning performance. The document focuses on establishing substantial equivalence to predicate devices, primarily through design, materials, and mechanical performance testing.
However, based on the information provided, we can extract details related to the performance testing that was submitted:
1. A table of acceptance criteria and the reported device performance:
The document mentions "Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18 was presented to demonstrate substantial equivalency."
While specific numerical acceptance criteria and reported values are not provided in this summary, the standard ASTM F2554-18 focuses on positional accuracy. For a stereotaxic instrument, the key performance metric would be the accuracy with which it guides the surgeon to the intended anatomical location.
| Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|
| Positional Accuracy (as per ASTM F2554-18) | Demonstrated substantial equivalency to the Medtronic CD HORIZON® Spinal System (K170679) based on this testing. Specific quantitative results are not provided in this summary. |
| Functionality and compatibility with Medtronic® StealthStation® System using NavLock tracker | Design validation performed to ensure acceptability for intended use and functionality. Specific results not provided. |
| Dimensional comparison and tolerance analysis | Performed to ensure acceptability for intended use. Specific results not provided. |
2. Sample size used for the test set and the data provenance:
The document does not specify a "test set" in the context of an AI/ML algorithm or a dataset for performance evaluation. The testing performed is described as "Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18," which typically involves physical measurements on a phantom or test setup rather than a patient dataset. Therefore, information about data provenance (country of origin, retrospective/prospective) and sample size for a "test set" in the context of data-driven AI/ML is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the submission relates to a surgical navigation instrument system, not an AI/ML diagnostic or predictive device requiring ground truth from human experts on a dataset.
4. Adjudication method for the test set:
Not applicable, as the testing described does not involve human interpretation of a test set that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a surgical navigation instrument, not an AI assistance tool for human readers/clinicians in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an instrument system designed to be used with a navigation system (Medtronic StealthStation) and a surgeon. It is not a standalone algorithm.
7. The type of ground truth used:
For the positional accuracy testing (ASTM F2554-18), the ground truth would typically be established by precise metrology instruments or a known, highly accurate reference within the test setup, adhering to the specifications of the standard. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for AI/ML.
8. The sample size for the training set:
Not applicable. This device does not appear to be an AI/ML device that requires a training set. The performance testing is based on physical and mechanical evaluations.
9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set for an AI/ML component.
§ 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).