(166 days)
The Stryker Spine Aviator® Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) Trauma (including fractures) Tumors Deformities or curvatures (including kyphosis, lordosis, or scoliosis) Pseudoarthrosis Failed previous fusion Decompression of the spinal cord following total or partial cervical vertebrectomy Spondylolisthesis Spinal Stenosis
The purpose of this 510(k) is to summarize the design modifications that have been implemented to the Aviator® Anterior Cervical Plating (ACP) System previously FDA cleared via K083562. No new implant reference numbers/part numbers were created. Additionally, there were no changes to the previously FDA cleared indications, intended uses, mode of operation, scientific technology, materials of construction, or to the performance of the device.
The Aviator® Anterior Cervical system are one-, two-, three-, and four-level plate configurations ranging in lengths from 12 mm to 22 mm for the one-level plates, 24mm to 46mm for the two-level plates, 39 mm to 69 mm for the three-level plates, and 56 mm to 96 mm for the four-level plates. All of the plate levels incorporate a spring bar blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with either fixed or variable angles available in self-tapping or self-drilling designs. The variable angle bone screws allow the screw to be placed into bone at various degrees of angulation, while the fixed bone screws are inserted at a defined angle. Any combination of bone screws can be used to secure the cervical plate. The bone screws are offered in 4.0 mm and 4.35 mm diameters in lengths of 10 mm – 20 mm. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (TI6Al4V).
The associated instrumentation (such as awls, punch awls, screwdrivers, handles, drill guides and drill bits, plate bender, storage and transport trays/container, and fixation pins) are Class I / 510(k) exempt devices under 21 CFR §888.4540.
The provided document describes modifications to the Stryker Spine Aviator® Anterior Cervical Plating (ACP) System (K142237) and compares it to its predicate device (K083562). The focus of this submission is to demonstrate substantial equivalence by showing that the design modifications did not negatively impact the device's performance, safety, or efficacy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of quantified benchmarks. Instead, it demonstrates equivalence to a predicate device by showing that the modified device performs comparably in specific biomechanical tests and maintains the same technological characteristics. The implicit acceptance criterion is that the modified device's performance is at least equivalent to, and not worse than, the predicate device in the specified tests.
| Feature / Test | Acceptance Criteria (Implicit: Comparable to K083562 Predicate) | Reported Device Performance (Modified Aviator® ACP System) |
|---|---|---|
| Technological Characteristics | - Same locking mechanism (Spring-loaded Spring Bar, pre-assembled) |
- Same anti-backout mechanism (opens with screw)
- Same integration with plate
- Same thickness of anti-backout mechanism (.3-.4 mm)
- Same material (Ti 6AL-4V)
- Same number of screw holes mechanism supports (1 screw hole)
- Same basic plate shape ("Dogbone" design with graft viewing windows)
- Same plate levels (One-, Two-, Three-, and Four- level configurations)
- Same plate lengths
- Same plate width (17.4mm)
- Same plate profile (2.5mm thickness, smooth surface)
- Same plate curvature
- Same plate screw-hole geometry
- Same bone screw diameter (4.0mm and 4.35mm) | All technological characteristics listed were identical to the predicate device (K083562). |
| Mechanical Performance (Bench Testing) | - Performance comparable to the predicate device in ASTM 1717-09 for Static and Dynamic Compression Bending, and Static Torsion Tests. - Performance comparable to the predicate device in ASTM 1798-97 for Static Cantilever Bending.
- No new failure modes.
- No new risks identified.
- No establishment of a new worst-case construct. | - All previous ASTM testing submitted with K083562 were repeated for the modified device.
- "The non-clinical test results were comparable to the predicate design and demonstrated that implemented modifications did not adversely impact device performance, and the safety and effectiveness profile of the device."
- "There were no new failure modes, identification of new risks, or establishment of a new worst-case construct as a result of the design changes." |
| Indications for Use | Identical indications for use as the predicate device. | "The implemented design modifications did not alter the fundamental scientific technology or change/introduce an energy source. The modified devices retained previously FDA cleared indications/intended use and mode of operation as presented in 510(k) #K083562." |
2. Sample Size Used for the Test Set and the Data Provenance:
The document refers to "cadaveric and bench design verification testing." For the biomechanical testing, the sample size is not explicitly stated in terms of number of constructs or replicates. However, it indicates that the ASTM standards listed (ASTM 1717-09 and ASTM 1798-97) were followed. These standards typically specify minimum sample sizes for such tests.
The data provenance is from bench testing and cadaveric testing. This suggests it's prospective data gathered specifically for this submission, rather than retrospective analysis of existing clinical outcomes. The country of origin of the data is not specified but is implicitly associated with Stryker Spine's R&D efforts, likely within the US, given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the study described is a non-clinical, biomechanical and cadaveric testing study, not a study involving human readers or clinical interpretation requiring expert consensus for ground truth. The "ground truth" here is the objective measurement of mechanical properties according to established ASTM standards.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or studies involving human assessment of images or data where there might be inter-reader variability.
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 information is not applicable. The device (Aviator® Anterior Cervical Plating System) is a physical implant for spinal fusion, 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 irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the biomechanical performance testing (ASTM 1717 and ASTM 1798) is based on objective physical measurements derived from controlled laboratory experiments using standardized test methods. For the cadaveric testing, the ground truth would also be based on physical observations and measurements of the device's behavior in tissue. It is not dependent on expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather on engineering principles and test standards.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of device modifications to an existing spinal implant. The testing described is verification testing against established performance parameters of a predicate device. This is not an AI/machine learning application where training sets are used.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
§ 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.