Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
The Fusion Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Fusion System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the ATEC Invictus® Spinal Fixation System.
The Fusion Robotic Navigation System is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in the pedicles of the lumbar spine.
The provided text describes a 510(k) premarket notification for the Fusion Robotic Navigation System. This submission asserts substantial equivalence to a predicate device (REMI Robotic Navigation System K223070) rather than presenting a performance study with acceptance criteria in the traditional sense of a clinical trial or extensive standalone validation.
The key change described in this submission is the compatibility of the Fusion Robotic Navigation System with the ATEC Invictus® Spinal Fixation System, which includes the introduction of three new instruments: the Invictus Guide Tube, Invictus 8mm Guide Tube Sleeve, and Invictus MIS Screwdriver.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence to the predicate device, primarily through an engineering analysis rather than a new clinical performance study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission based on an engineering analysis of new instruments, the "acceptance criteria" pertain to maintaining the critical features and performance of the predicate device despite the introduction of new compatible instruments. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) provided that would typically arise from a standalone or clinical study.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as per Engineering Analysis) |
|---|---|
| Material Equivalence: New instruments (Invictus Guide Tube, Invictus 8mm Guide Tube Sleeve, Invictus MIS Screwdriver) use same materials as predicate. | The new instruments are manufactured from the same materials used in the predicate system. |
| Manufacturing Process Equivalence: New instruments follow same manufacturing processes as predicate. | The new instruments follow the same manufacturing processes as the predicate system. |
| Biocompatibility: New instruments do not introduce a worst-case scenario. | New instruments do not introduce a worst case for biocompatibility. |
| Cleaning & Sterilization: New instruments do not introduce a worst-case scenario. | New instruments do not introduce a worst case for cleaning or sterilization. |
| Risk Assessment: No new risks identified or existing risks impacted by new instruments. | No new risks were identified, and no existing risks were impacted by the addition of the Invictus® Spinal Fixation System instruments. |
| Design Requirements: No new requirements added, existing requirements continue to be met. | No requirements were added to the design requirement as a part of this change. The subject device continues to meet design requirements. |
| Critical Features: Invictus® Spinal Fixation System instruments maintain all the same critical features as the predicate designs. | Invictus® Spinal Fixation System instruments maintain all the same critical features as the predicate designs. |
| Tolerance Stackup: Tolerance stackup does not create any new worst-case conditions. | The stackup of the tolerances do not create any new worst-case conditions. |
| Usage Equivalence: Invictus® Spinal Fixation System instruments are used in an identical manner with the same software as predicate versions. | The Invictus® Spinal Fixation System instruments are used in an identical manner to the predicate versions using the same software. |
| Overall Safety & Effectiveness: Device remains as safe and effective as the predicate device and performs according to its intended use. | The subject device continues to meet design requirements, is as safe and effective as the predicate device, and performs according to its intended use. |
| Substantial Equivalence: Demonstrated to the predicate REMI Robotic Navigation System (K223070). | The engineering analysis performed on the new instrumentation demonstrated that the characteristics of the subject Fusion Robotic Navigation System is substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not describe a traditional "test set" with patient data or clinical cases. The "test" involved an engineering analysis comparing designs. There is no mention of a sample size of patients or data provenance in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this submission is based on the design specifications and performance characteristics of the predicate device and the engineering comparison of the new instruments to those specifications. There were no "experts" in the context of clinical adjudication for a test set mentioned.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication.
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 robotic navigation system, not an AI imaging analysis tool, and the submission does not describe a comparative effectiveness study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm in the traditional sense for diagnostic or prognostic purposes. The performance assessment was based on an engineering analysis of the physical components and their interaction within the system, not a standalone algorithm output.
7. The type of ground truth used
The "ground truth" for this submission is the established design requirements, material specifications, and functional performance characteristics of the predicate device, against which the new compatible instruments were compared via engineering analysis.
8. The sample size for the training set
Not applicable. This submission concerns hardware modifications and compatibility, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there was no training set mentioned.
Ask a specific question about this device
Page 1 of 1