Search Results

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)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis

WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

This Special 510(k) premarket notification is intended to introduce the following line extensions to the Reflex Hybrid Plates and Bone Screws approved under K062310 and K040261:

• Aviator plates in 1-level, 2-level, 3-level, and 4-level configurations and in lengths ranging from 12mm through 96mm
• Aviator 4.0 mm and 4.35mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle selfdrilling and fixed-angle self-tapping)

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 intended use and materials of the subject anterior cervical plates are identical to those of the predicate anterior cervical plates. The predicate Reflex® Hybrid Anterior Cervical Plate (ACP) System consists of various size plates that are implanted and remain static. The subject system introduces various length plates that contain a new "spring bar" anti-backout mechanism similar to the existing Reflex Hybrid "locking ring" anti-backout mechanism. In addition to the new anti-backout mechanism introduced on the Aviator plate, new screws have been introduced with a modified head. Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stryker Spine Aviator Anterior Cervical Plating (ACP) System:

Summary of Findings: The provided document is a 510(k) premarket notification for a line extension to an existing device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and performance testing, rather than extensive clinical studies with specific acceptance criteria related to a new AI or diagnostic device function. Therefore, many of the requested fields are not directly applicable or explicitly stated in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) premarket notification for a line extension to an existing medical device (spinal implant). This type of submission primarily focuses on demonstrating "substantial equivalence" to predicate devices through design comparisons, material equivalence, and non-clinical engineering testing. It does not typically include specific clinical acceptance criteria, detailed accuracy metrics (like sensitivity/specificity), or performance outcomes in the way one would see for a novel diagnostic or AI-powered device.

The document states: "Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems." This is the overarching "acceptance criterion" for a 510(k) submission – to prove the new device is as safe and effective as a legally marketed predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of a clinical patient sample size. The "test set" here refers to the components subjected to engineering and performance bench testing. The document implies sufficient testing was done to support the claim of substantial equivalence.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of clinical data for this type of 510(k) submission. The data would primarily be from internal laboratory engineering tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated or applicable in the way one would assess diagnostic accuracy. For engineering analysis and performance testing, the "experts" would be the design engineers, test engineers, and regulatory affairs personnel involved in the device design and testing, as well as the FDA reviewers.
• Qualifications of Experts: The regulatory affairs consultant, Vikki O'Connor, is named. The design and testing would be handled by qualified engineers and scientists within Stryker Spine. FDA reviewers (e.g., Mark N. Melkerson, Director of the Division of General, Restorative and Neurological Devices) are experts in medical device regulation and evaluation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This refers to the process of resolving discrepancies among multiple human readers for ground truth establishment. For engineering tests, the "ground truth" is defined by established test methods, specifications, and observed results, which are then analyzed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Was an MRMC study done? No. This submission does not involve an AI component or a diagnostic interpretation task that would necessitate an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Was a standalone study done? Not applicable. This device is a physical implant, not a software algorithm. The "standalone performance" refers to the device's mechanical and material properties as tested in a lab setting.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance is established through engineering specifications, material standards, and validated mechanical and physical performance testing methods. This ensures the device meets design requirements and performs comparably to the predicate devices under simulated physiological conditions. Examples include tests for strength, fatigue, material compatibility, and anti-backout mechanism effectiveness.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As there is no AI algorithm, there is no training set or ground truth in this context.

Ask a specific question about this device