(115 days)
The Navigated Disc Preparation Instruments are intended to facilitate a discectomy during spinal surgery. The Navigated CAPSTONE™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for ELEVATE™ Spinal System, they are intended to be used to facilitate implant size selection.
The Navigated Probe is intended to be used during pedicle and disc preparation during spinal fusion procedures. The Navigated Inserters are intended to be used for the placement of an implant.
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.
The Navigated ELEVATE™ Inserter and navigated rotating shavers are non-sterile, reusable surgical instruments that are intended to be used to facilitate a discectomy and placement of implants during spinal surgery procedure. The subject devices are designed specifically to be used with ELEVATE™ Spinal System and are also compatible with the StealthStation. These devices are offered in non-sterile form and are reusable. This subject devices are manufactured from stainless steel and silicone. The case and trays are manufactured from aluminum with either silicone or nylon coated brackets.
The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific device performance criteria with clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert ground truth, and MRMC studies is not detailed in this type of submission.
However, I can extract the available information regarding performance data.
Table of Acceptance Criteria and Reported Device Performance
The submission summarizes "Performance Data" through a series of tests to ensure functionality and compatibility. The specific "acceptance criteria" are implied by the nature of these tests (e.g., successful function, accurate navigation, correct mating) rather than quantified metrics with thresholds.
| Test | Description | Reported Device Performance (Implied from "Confirmed" and "Verified") |
|---|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy in both 2D and 3D space. | Navigation accuracy of the instrument was confirmed in both 2D and 3D space. |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions. | Instrument functionality was confirmed under expected use conditions. |
| Navigation Simulated Use | Confirmed navigation system functionality under expected use conditions. | Navigation system functionality was confirmed under expected use conditions. |
| CAD Model Evaluation | Verified that the CAD models are accurately reflected in the application software. | CAD models were verified to be accurately reflected in the application software. |
| Implant/Instrument Mating Conditions | Verified that the instruments can be assembled with the appropriate devices according to their intended use. | Instruments were verified to be assembled with 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. | The Spine Tools package (Version 25, compatible with Synergy Spine 2.1 application on the S7) was verified to meet the required interface needs of the spine application software. |
Details Not Available in the Provided Text:
The following information is not present in the provided 510(k) summary, as these types of details typically come from more in-depth study reports which are usually not included in the publicly available summary for a 510(k) submission.
- Sample size used for the test set and the data provenance: Not specified. This submission focuses on design and function verification, not clinical data from patients. The tests mentioned appear to be laboratory or bench-top evaluations.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. "Ground truth" in the clinical sense (e.g., diagnosis) is not relevant for these engineering verification tests.
- Adjudication method for the test set: Not specified.
- 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 instrument system, not an AI diagnostic tool, and no MRMC studies are mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a navigated surgical instrument, inherently used with a human in the loop.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests listed, the "ground truth" would be engineering specifications, physical measurements, and proper functional operation according to design, not clinical ground truth.
- The sample size for the training set: Not applicable. This device does not use machine learning in a way that requires a "training set" in the conventional sense of AI/algorithm development. The "Spine Tools Package" refers to software compatibility and functionality, not an AI model.
- How the ground truth for the training set was established: 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).