(164 days)
The Vectra-One System is intended for anterior plate and screw fixation of the cervical spine (C2-C7) for the following indications:
Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Spondylolisthesis Trauma (i.e., fractures or dislocations) Spinal stenosis Tumors (primary and metastatic) Failed previous fusions Pseudarthrosis Deformity (i.e., kyphosis, lordosis and/or scoliosis)
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Synthes Vectra-One System consists of titanium plates with an integrated one-step blocking mechanism. This blocking mechanism consists of a resilient clip pre-assembled in each bone-screw-receiving hole's radial groove to block a bone screw from backing out in the event of lost bone purchase. This construct allows either a Fixed Angle Screw (a screw with fixed insertion angle) or Variable Angle Screw (a screw with a range of insertion angle which permits the screw-head to angulate inside the bone-screw-hole after being threaded into a bone) to be used. The Vectra-One System uses the identical and compatible bone-screws from the Synthes Vectra System (K050451). Furthermore, the integrated one-step blocking mechanism is identical to the mechanism from the Synthes Vectra System (K050451).
The provided document, K071667, is a 510(k) Summary for the Synthes Vectra-One System. This device is a spinal intervertebral body fixation orthosis. The summary focuses on establishing substantial equivalence to predicate devices based on design, function, material, and intended use, rather than demonstrating performance against specific quantitative acceptance criteria of a novel device. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert adjudication, and sample sizes is not explicitly provided in the document for this type of medical device submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit for spinal fixation systems) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (Synthes Anterior Cervical Vertebra Plates (K926453), Synthes Vectra System (K050451), Synthes Cervical Vertebrae Plates (K792352), DePuy Spine UniPlate Anterior Cervical Plate System (K042544)) in design, function, material, and intended use. | The Synthes Vectra-One System is described as a result of design modifications to the predicate devices. It is stated to be substantially equivalent to the predicates in design, function, material, and intended use. The integrated one-step blocking mechanism is identical to the mechanism from the Synthes Vectra System (K050451). The System uses identical and compatible bone-screws from the Synthes Vectra System (K050451). |
| Mechanical/Biomechanical Performance (e.g., strength, stability, screw retention) | Bench testing results demonstrate that the Synthes Vectra-One System is substantially equivalent to the predicate devices. (Specific quantitative criteria or results are not provided in this summary.) |
| Clinical Safety and Effectiveness | Clinical data and conclusions were not needed for this device. (This indicates that the FDA considered the substantial equivalence demonstrated through design and bench testing sufficient to infer clinical safety and effectiveness based on the predicate devices.) |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not applicable/Not specified in the provided document. The submission relies on design comparison and bench testing, not a clinical test set in the traditional sense.
- Data provenance: Not explicitly stated for specific test data, but the bench testing would have been conducted by the manufacturer, Synthes Spine.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. "Ground truth" in the context of device performance would typically refer to established engineering standards or the performance of predicate devices. The document does not detail specific expert panels for interpreting test results beyond the manufacturer's internal engineering and regulatory teams and eventually the FDA's review.
4. Adjudication method for the test set:
- Not applicable/Not specified. As there's no clinical "test set" with subjective interpretations, an adjudication method for ground truth is not relevant here.
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 physical medical implant (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the non-clinical performance, the "ground truth" implicitly refers to engineering standards and direct comparison with the mechanical and material properties of the predicate devices. The concept of "ground truth" as pathology results or outcomes data is not directly applicable to the non-clinical bench testing for this type of device.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.