(181 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 (TI-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 ZIPIM MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical 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.
This document is a 510(k) premarket notification for a medical device called the "ZIP™ MIS Interspinous Fusion System" by Aurora Spine, Incorporated. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.
Based on the provided text, the device is a mechanical implant, not an AI/ML-driven device or an imaging device, and therefore the concepts of acceptance criteria regarding accuracy, precision, sensitivity, specificity, MRMC studies, or standalone algorithm performance are not applicable in the way they would be for AI-based diagnostic tools.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biological performance of the implant and its substantial equivalence to a predicate device.
Here's an attempt to answer the questions based on what is available and extrapolate where necessary, acknowledging the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a discrete table of acceptance criteria with corresponding performance metrics in a format typical for AI/ML device evaluations. Instead, the acceptance criterion is implicitly "substantial equivalence" to a predicate device in terms of safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Properties & Biocompatibility: Equivalent to predicate device. | The device's nature (interspinous fusion system) implies use of biocompatible materials. The document states "no changes to the intended use of the device or its fundamental scientific technology," and mentions materials as a comparative factor ("materials" in predicate comparison section), suggesting equivalence implicitly accepted. |
| Mechanical Performance (Strength, Durability, Fixation): Equivalent to predicate device. | Non-Clinical Testing: Finite Element Analysis (FEA) testing was conducted. "FEA testing showed the additional geometries of the subject device do not offer a worst-case scenario as compared to the predicate ZIP™ MIS Interspinous Fusion System components." This implies the new geometries meet or exceed the performance of the predicate. |
| Functional Equivalence: Performs the same function as the predicate device. | "The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device... intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion." "No changes to the intended use of the device or its fundamental scientific technology." |
| Biomechanical Stability / Supplemental Fusion: Provides similar stability and promotes fusion as predicate device. | "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 FEA testing likely supports this. |
| Safety Profile: No new safety concerns compared to predicate. | No new safety concerns are mentioned. The substantial equivalence claim is based on "indications, design, function, performance and materials" being equivalent to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial test set for software. The primary "test set" for this submission was the CAD models used for Finite Element Analysis (FEA) of the device's mechanical properties. The document does not specify the number of FEA models or simulations.
- Data Provenance: The FEA testing would be computational and likely performed by the manufacturer or a contract lab. Country of origin of data is not specified but would be related to the location of the FEA execution. This is a non-clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Ground Truth Experts: Not explicitly stated. For a mechanical device being evaluated via FEA, the "ground truth" for the FEA would be based on engineering principles, materials science data, and established biomechanical models. The expertise would lie with the engineers and scientists who designed the FEA models and interpreted the results. This doesn't involve medical experts in the way AI image analysis would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is typically for resolving discrepancies in human expert interpretations of ground truth for diagnostic tests. For FEA, the results are computational and typically verified through engineering checks and comparisons to known benchmarks or predicate device performance.
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
- MRMC Study: No. This type of study is completely irrelevant for a mechanical interspinous fusion system. MRMC studies are for evaluating the diagnostic performance of AI algorithms, particularly in imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a surgical implant, not an algorithm. Its performance is physical and biological, not computational in a diagnostic sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the non-clinical testing, the "ground truth" for the FEA simulations would be based on:
- Engineering principles and material properties: Known physical laws and validated material data.
- Predicate device performance data: The performance of the previously cleared predicate device serves as the benchmark against which the modified device is compared to establish substantial equivalence.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
In summary, this 510(k) submission is for a modification to a mechanical surgical implant. The "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, primarily through non-clinical mechanical testing (Finite Element Analysis) rather than clinical studies or evaluations of AI performance.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.