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510(k) Data Aggregation
(27 days)
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.
The Aurora Spine ZIPTM MIS Interspinous Fusion System is a medical device that adds new sizes and configurations to the Aurora Spine ZIPTM MIS Interspinous Fusion System. This device is a posterior, non-pedicle supplemental fixation device. It is intended for use in the non-cervical spine (T1-S1). This device is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor.
Here's an analysis of the provided information regarding its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary is for a Special 510(k) submission, which typically means adding new sizes and configurations to an already cleared device (predicate device K133091). For such submissions, the primary acceptance criteria revolve around demonstrating that the modifications do not alter the fundamental safety and effectiveness of the device compared to the predicate. This is often achieved through comparative analysis and engineering testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Equivalence | The modified components' materials are substantially equivalent to the predicate device's materials. This is an implicit criterion for Special 510(k)s unless stated otherwise. | The document explicitly states: "The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091) with respect to indications, design, function, performance and materials." |
| Design Equivalence | The modified components' design is substantially equivalent to the predicate device's design, ensuring no adverse impact on function or safety. | "The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091) with respect to indications, design, function, performance and materials." |
| Functional Equivalence | The modified components perform their intended function similarly to the predicate device. | "The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091) with respect to indications, design, function, performance and materials." |
| Performance Equivalence | The mechanical performance (e.g., strength, durability, stability) of the modified components meets or exceeds that of the predicate device, especially under simulated physiological loads. Specifically, in accordance with relevant ASTM standards. | "Finite element analysis (FEA) was performed, in additional to engineering rationales, on the modified components compared to the predicate ZIPTM components, and the results demonstrate that they are substantially equivalent to the predicate device. The analysis included static compression loading, static torsion, and dynamic compression per ASTM F1717-13 and axial disassociation loading." This directly addresses the performance of the new sizes/configurations matching/exceeding the predicate. Performance is deemed substantially equivalent. |
| Intended Use | The modifications do not change the indications for use or the fundamental scientific technology of the device. | "There have been no changes to the intended use of the device or its fundamental scientific technology." and "The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K133091) with respect to indications..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical or image-based test sets. The study involved finite element analysis (FEA) and engineering rationales of the modified components. This means computational models were used, not patient data or physical test samples in the traditional sense of a "test set" for AI/software.
- Data Provenance: Not applicable. This is a mechanical/computational study, not a clinical data study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. For FEA and engineering rationales, the "ground truth" is established by adherence to engineering principles, material science, and validated computational methods, often overseen by qualified engineers and biomechanics specialists. No human experts in the context of clinical review were used to establish ground truth for this type of study.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This was a mechanical/computational study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
- MRMC Study: No. This submission describes a mechanical engineering study, not an MRMC study related to AI or human reader performance. This device is a physical implant, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone performance does not apply.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this engineering study is based on established mechanical engineering principles, material properties, and the validated performance of the predicate device. The FEA models are built upon these principles, and their results are compared against the expected performance derived from the predicate and relevant ASTM standards (ASTM F1717-13).
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/machine learning study that would involve a "training set." The "training" in this context is the validation of the FEA models and engineering methodologies against known physical properties and standards.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training was Established: Not applicable. There isn't a "training set" in the sense of data labeled by experts. The "ground truth" for ensuring the accuracy of the computational methods (FEA) would be established through:
- Validation of FEA models: Comparing FEA predictions to physical test results of components (either the predicate or test coupons) where experimental data is available.
- Adherence to ASTM standards: Ensuring the simulation parameters and failure criteria align with recognized industry standards for spinal implant testing (e.g., ASTM F1717-13).
- Engineering principles: The underlying equations and assumptions in finite element analysis are based on well-established principles of mechanics and material science.
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