(58 days)
The NEXXT SPINE NAVIGATION System is an instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The NEXXT SPINE NAVIGATION System is an instrumentation system which includes taps and a probe, an awl and an inserter. The devices are used in conjunction with the Medtronic® StealthStation Navigation System to assist with placement of the Nexxt Spine INERTIA® Systems (INERTIA® Pedicle Screw and INERTIA® Pedicle Screw and Deformity Correxxion System) pedicle screws. The instruments are sold non-sterile and are reusable.
Here's an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study, focusing on the requested categories:
Device Name: NEXXT SPINE NAVIGATION System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance (as per study) |
|---|---|
| Dimensional Analysis | Demonstrated substantial equivalence to predicate device. |
| Positional Accuracy | Demonstrated substantial equivalence to predicate device. |
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.
The provenance of the data is that it was generated through side-by-side testing of the NEXXT SPINE NAVIGATION System and the predicate device. The text does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number or qualifications of experts used to establish ground truth. The study appears to be a technical performance test rather than involving clinical experts for ground truth assessment.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The study outlined is a technical performance study comparing the device to a predicate, not a study evaluating human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Yes, a standalone performance study was conducted. The "Navigation dimensional analysis and positional accuracy validations" were performed on the device itself, comparing its technical performance to a predicate device, without the involvement of human operators or a human-in-the-loop scenario.
7. Type of Ground Truth Used:
The ground truth for the performance tests appears to be established by technical measurements and standards as per ASTM F2554. This standard likely defines acceptable dimensional and positional accuracy, which served as the "ground truth" against which the device's performance was measured. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. This is expected given that the device is an instrumentation system with navigation capabilities, not an AI or machine learning algorithm that typically requires a training set. The performance data focuses on inherent accuracy and dimensional properties.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, the establishment of ground truth for a training set is 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).