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510(k) Data Aggregation
(185 days)
Altus Spine Navigation System
The Altus Spine Navigation System reusable instruments are indicated to be used during the preparation and placement of Altus Spine Valencia Pedicle Screw System and Altus Spine Monaco Pedicle Screw System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Altus Spine Navigation System reusable instruments are specifically designed for use with the Medtronic StealthStation® System S8, 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 for the anatomy.
• For a comprehensive summary of indications, the IFU for the specific system of use must be directly referenced: Altus Spine Valencia Pedicle Screw System / Altus Spine Monaco Pedicle Screw System.
The Altus Spine Navigation System is intended to pair with either the Altus Spine Valencia Pedicle Screw System or Altus Spine Monaco Pedicle Screw system to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The Altus Spine Navigation system may be used for noncervical pedicle fixation via posterior percutaneous approach with MIS instrumentation.
The Altus Spine Navigation System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The Altus Spine Navigation System includes the following instruments dedicated to screw placement: Screwdrivers and Taps. The Altus Spine Navigation System is to be used with the following Altus Spine Systems:
▪ Altus Spine Valencia Pedicle Screw System
▪ Altus Spine Monaco Pedicle Screw System
All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided non sterile. The Altus Spine Navigation System instruments are not compatible with implants from other manufacturers. The Altus Spine Navigation System are designed for use only with Medtronic StealthStation® System S8 (V2.1.0) and the Medtronic NavLock® Tracker System.
Based on the provided FDA 510(k) clearance letter for the Altus Spine Navigation System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Recognition and Location Accuracy with Medtronic StealthStation® System S8 (via ASTM F2554) | "The Altus Spine Navigation System was tested side-by-side with the primary predicate device and passed recognition and location testing with the Medtronic StealthStation® System S8 navigation system via ASTM F2554." |
| Dimensional Accuracy (with primary predicate device) | "The subject device and predicate device were compared for dimensional accuracy and the critical length. The results demonstrate that the subject device is substantially equivalent to the predicate device in use and performance." |
| Critical Length (with primary predicate device) | "The subject device and predicate device were compared for dimensional accuracy and the critical length. The results demonstrate that the subject device is substantially equivalent to the predicate device in use and performance." |
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 (number of instruments tested or number of trials). It only mentions that the Altus Spine Navigation System was "tested side-by-side with the primary predicate device."
Regarding data provenance:
- Country of Origin: Not specified, but implied to be related to Altus Partners, LLC (Pennsylvania, USA) and Medtronic (USA).
- Retrospective or Prospective: The testing described ("tested side-by-side") suggests a prospective performance evaluation conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. The nature of the testing (recognition, location accuracy, dimensional accuracy, and critical length using ASTM F2554) suggests an objective, measurement-based ground truth rather than a subjective expert assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given the objective, measurement-based nature of the performance tests (ASTM F2554, dimensional comparisons), an adjudication process like 2+1 or 3+1 (typically used for subjective assessments by multiple readers) would not be applicable or necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance.
No, an MRMC comparative effectiveness study was not done.
This device (Altus Spine Navigation System) is a set of reusable surgical instruments designed to interface with an existing navigation system (Medtronic StealthStation® System S8). It is not an AI-powered diagnostic software or a device that directly assists "human readers" in interpreting medical images. Therefore, a study comparing human reader performance with and without AI assistance is not relevant to this device's function or clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Yes, the performance tests described are essentially "standalone" device performance tests.
The tests evaluated the instruments themselves in their ability to be recognized and tracked accurately by the Medtronic StealthStation® System S8, and their dimensional accuracy. This is a characteristic of the device itself, independent of a specific surgeon's performance or interpretation during a procedure. It's about the technical performance of the physical instruments.
7. The Type of Ground Truth Used
The ground truth used for these performance tests was objective, measurement-based data derived from:
- Standardized Test Methods: Adherence to ASTM F2554 for recognition and location accuracy.
- Physical Measurements: Dimensional accuracy and critical length comparisons.
This is not a ground truth derived from expert consensus, pathology, or outcomes data, as those are typically used for diagnostic or therapeutic devices where subjective interpretation or clinical effect is being assessed.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. The Altus Spine Navigation System is a set of physical surgical instruments, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, this question is not relevant to the Altus Spine Navigation System.
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