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510(k) Data Aggregation
(58 days)
The Aurora Spine ZIPTM MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T)-SI). 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 ZIPTM 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 ZIP™ MIS Interspinous Fusion System is manufactured from titanium alloy (Ti-6A1-4V ELI in accordance with ASTM F136 or ISO 5832-3).
This document describes a 510(k) submission for a medical device called the Aurora Spine ZIP™ MIS Interspinous Fusion System. It is a spinal implant, not an AI/ML device, and therefore the standard AI/ML device performance criteria, such as those related to accuracy, sensitivity, and specificity, are not applicable here.
Instead, the acceptance criteria for this type of device focus on substantial equivalence to existing legally marketed predicate devices, primarily demonstrated through biocompatibility, mechanical performance, and materials testing.
Here's an analysis based on the provided text, aligning with the spirit of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Testing |
|---|---|---|
| Material Equivalence | The device's material composition should be identical or substantially equivalent to that of predicate devices, with established history of safe use in the human body. | Manufactured from titanium alloy (Ti-6A1-4V ELI) in accordance with ASTM F136 or ISO 5832-3. This material is widely used and accepted in spinal implants, matching the expectations for predicate devices. |
| Biocompatibility | The device material must be biocompatible, meaning it does not produce adverse biological responses (e.g., cytotoxicity, sensitization, irritation) when in contact with tissues. (Although not explicitly detailed, this is an inherent requirement for all implantable devices). | Implicitly met through the use of Ti-6A1-4V ELI, a well-established biocompatible material for implantable devices. Further specific biocompatibility testing (e.g., ISO 10993 series) would have been performed and reviewed by the FDA, even if not explicitly summarized in this public document. |
| Mechanical Performance | The device must demonstrate mechanical strength and fatigue resistance suitable for its intended use, comparable to predicate devices. This includes static and dynamic loading scenarios to simulate physiological conditions. Specifically, performance against ASTM F1717 standards is mentioned for interspinous process distraction devices. | "Testing performed on this device indicates that the Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met. This testing included static compression bending, static torsion, dynamic compression bending, and disassociation testing in UHMWPE test blocks." Results are stated to meet the standards, implying they are comparable or superior to the predicate devices. |
| Design and Function | The device's design and functional principles should be substantially equivalent to predicate devices to achieve the stated indications for use. | "The Aurora Spine ZIP™ MIS Interspinous Fusion System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used." It is described as a "bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes," consistent with the function of interspinous fusion devices. |
| Indications for Use | The device's intended clinical applications must be substantially equivalent to those of the predicate devices. | The text explicitly states the device "has the same indications for use" as the predicate devices. The specific indications for use are detailed in the "Indications For Use" section, covering degenerative disc disease, spondylolisthesis, trauma, and/or tumor, for supplemental fusion with bone graft material at single non-cervical levels. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document describes bench testing (mechanical testing), not a clinical study with patient samples. The "test set" here refers to the number of physical devices and test rigs used for mechanical evaluation. The exact number of devices tested for each mechanical test (static compression bending, static torsion, dynamic compression bending, and disassociation testing) is not specified in the provided 510(k) summary. However, such testing typically involves a statistically relevant number of samples to ensure reproducibility and reliability of results, as specified by the ASTM F1717 standard.
- Data Provenance: The data provenance for this bench testing is the manufacturer's internal testing facilities or a contracted testing laboratory. There's no mention of patient data or clinical trials, as this is a 510(k) submission primarily relying on substantial equivalence to predicates through non-clinical data. The data is prospective in the sense that the tests were conducted specifically for this submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable to this type of medical device submission. Ground truth, in the context of AI/ML or diagnostic devices, refers to a definitive diagnosis or outcome confirmed by human experts or other gold standards. For a spinal implant, "ground truth" is established by adherence to engineering standards (like ASTM F1717) and regulatory requirements, not by expert consensus on clinical cases. The "experts" in this context would be:
- Engineers and material scientists conducting and interpreting the mechanical tests based on established standards.
- FDA reviewers with expertise in orthopedic devices, biomechanics, and regulatory science, who evaluate the submitted data against compliance criteria. Their qualifications are not specified in the document but are inherent to their roles at the FDA.
4. Adjudication Method for the Test Set
- This question is not applicable to this type of medical device. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies or expert review panels to resolve discrepancies in diagnoses or interpretations, typically for diagnostic or imaging devices. For mechanical performance testing, the "adjudication" is met by demonstrating that the test results satisfy the quantitative criteria defined by the ASTM F1717 standard. If there were discrepancies in test results, they would be handled through repeat testing, error analysis, or re-design, rather than an expert adjudication process as understood in clinical evaluation.
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
- This question is not applicable. An MRMC study is relevant for diagnostic imaging AI/ML devices where the performance of human readers (e.g., radiologists) is compared with and without AI assistance. The Aurora Spine ZIP™ MIS Interspinous Fusion System is a surgical implant for spinal fusion and does not involve "human readers" or "AI assistance" in its direct function or evaluation for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is a concept that does not apply here.
7. The Type of Ground Truth Used
- The "ground truth" for this device, in the context of its 510(k) clearance, is demonstrated adherence to recognized consensus standards for mechanical performance (ASTM F1717) and material properties.
- It is not expert consensus on clinical cases, pathology, or outcomes data, as these are typically part of a higher-level regulatory pathway (PMA) or post-market surveillance for novel devices. For a 510(k), the "ground truth" for showing substantial equivalence rests on demonstrating that the device meets established engineering and material specifications that are known to be safe and effective for similar predicate devices.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" in the context of this device. Training sets are used to develop and refine AI/ML algorithms. This device is a manufactured physical good, not a software algorithm.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons as #8.
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