(263 days)
The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station 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 for the anatomy.
The SeaSpine Navigation System reusable instruments are Class II, manual, surgical instruments for use with the Medtronic StealthStation Navigation System S7 (v.2.1.0) and NavLock Tracker, to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of SeaSpine implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The instruments are manufactured from stainless steel per ASTM F899.
The SeaSpine Navigation Instruments include the following:
- Taps .
- Awl/Tap
- Probe ●
- Drills ●
- Drill/Tap Guides
The SeaSpine Navigation Instruments are to be used with the following FDA cleared SeaSpine Spinal Systems:
- Atoll
- Coral/Coral MIS ●
- Malibu Spinal System/Daytona ●
- Malibu Spinal System
- Daytona Small Stature ●
- Mariner Spinal System
- NewPort MIS ●
- . Sierra
This document describes the premarket notification (510(k)) for the SeaSpine Navigation System. Based on the provided text, the device is a set of reusable surgical instruments intended to assist surgeons in spinal surgery by precisely locating anatomical structures when used with the Medtronic StealthStation System.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of acceptance criteria and the reported device performance:
The document does not present explicit, quantitative acceptance criteria in a pass/fail table with numerical targets. Instead, the "Non-Clinical Testing" section describes a series of tests performed to ensure "compatibility, accuracy, function, and performance" of the SeaSpine Navigation System reusable instruments, aiming for substantial equivalence to predicate devices. The reported device performance is qualitative, stating that the tests were completed and "demonstrate that the SeaSpine Navigation System reusable instruments are substantially equivalent to the predicate."
Here's a summary of the tests and their qualitative outcomes as reported:
| Test | Description | Reported Performance |
|---|---|---|
| Registration | Performed to ensure the SeaSpine Navigation Instruments can be registered to the StealthStation. | Testing was performed to ensure registration capability. (Implies successful registration) |
| Navigation Accuracy | Completed for comparison to the reference instruments. | Accuracy testing was completed. (Implies satisfactory accuracy compared to reference) |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions. | Confirmed instrument functionality under expected use conditions. |
| Navigation Simulated Use | Confirmed the SeaSpine Navigation System functionality under expected use conditions. | Confirmed the SeaSpine Navigation System functionality under expected use conditions. |
| CAD Model Evaluation | Verified the CAD models are accurately reflected in the application software. | Verified CAD models are accurately reflected. |
| Rigidity | Evaluated the connection between the tracker and the instruments. | Rigidity testing evaluated the connection. (Implies satisfactory rigidity) |
| Implant/Instruments Mating Conditions | Verified the instruments can be assembled with the appropriate devices according to their intended use. | Verified proper assembly according to intended use. |
| Compatibility with the Medtronic StealthStation Navigation System | Evaluated to ensure the SeaSpine Navigation Instruments are compatible with the Medtronic StealthStation Navigation System. | Compatibility has been evaluated to ensure compatibility. |
2. Sample size used for the test set and the data provenance:
The document describes "engineering analysis" and "non-clinical testing" which involve physical testing of instruments and CAD model evaluation. It does not refer to a "test set" in the context of patient data or clinical images. The data provenance is from the manufacturer's internal testing as part of their 510(k) submission. No information about country of origin of data or whether it's retrospective/prospective is provided as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The evaluations are engineering tests (e.g., dimensional measurements, rigidity, functional checks with the navigation system), not interpretations of clinical data requiring expert consensus or ground truth establishment by medical professionals.
4. Adjudication method for the test set:
Not applicable. There's no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is a set of surgical instruments used with a navigation system, not an AI-powered diagnostic or assistive tool that would typically undergo an MRMC study. The submission focuses on substantial equivalence based on engineering and functional testing of the instruments themselves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a physical set of instruments, not a standalone algorithm. Its function is explicitly with human-in-the-loop (the surgeon) and with another medical device (Medtronic StealthStation System).
7. The type of ground truth used:
The "ground truth" for this device's evaluation is primarily based on:
- Engineering specifications and measurements: For dimensional accuracy, rigidity, etc.
- Functional performance criteria: Ensuring instruments register correctly, mate properly, and function as intended with the predicate navigation system.
- Comparison to predicate devices: The goal is substantial equivalence, meaning the performance is comparable to already marketed devices.
It is not based on expert consensus, pathology, or outcomes data, as this is a device for surgical assistance, and the submission primarily relies on non-clinical performance data for substantial equivalence.
8. The sample size for the training set:
Not applicable. This device is a set of physical instruments engineered for specific functions. There isn't a "training set" in the machine learning context.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device type.
§ 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).