(127 days)
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
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Pseudoarthrosis;
• Spondylolysis:
• Spondylolisthesis;
• Spinal stenosis;
• Tumors:
• Trauma (i.e. Fractures or Dislocation)
• Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
The DynaTran™ 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
The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine from C2 – T1. These systems are 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)
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal stenosis
The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes 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 UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and not intended for stand-alone use.
The previously cleared devices consist of a variety of plate systems designed to provide support across implanted levels in the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.
This document is a 510(k) summary for several spinal plate systems, primarily aimed at establishing an "MR Conditional" labeling claim. It describes a standalone performance study to demonstrate MR compatibility.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Magnetic Resonance Safety) | Reported Device Performance (as stated in the document) |
|---|---|
| Not explicitly stated within this document. The document only references "prescribed acceptance criteria" per ASTM F2503 for MR compatibility testing. | "The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices." |
Note: The specific numerical or qualitative acceptance criteria defined by ASTM F2503 and applied for this submission are not detailed in the provided text. The document broadly states that the devices met these criteria.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated. The document refers to "the subject devices" which is a collection of 5 different plate systems, each with potentially various sizes and configurations.
- Data Provenance: Not explicitly stated. The study described is a laboratory performance test (MR Compatibility testing per ASTM F2503), not a clinical study involving patient data. Therefore, concepts like country of origin or retrospective/prospective don't directly apply in the same way they would for a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This study is a technical performance test (MR Compatibility), not a clinical study requiring expert assessment for ground truth. The "ground truth" here is the physical property of MR compatibility as defined by the ASTM standard.
4. Adjudication Method for the Test Set
- Not applicable. As the study is a technical performance test, there is no adjudication process involving human reviewers. The assessment is based on objective measurements against the ASTM F2503 standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This document describes a technical MR compatibility study, not a clinical MRMC comparative effectiveness study involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes. The described study is a standalone performance study focused on the physical properties of the devices themselves (MR compatibility) without any human-in-the-loop component. It's a laboratory test of the device's inherent characteristics.
7. The Type of Ground Truth Used
- Standardized Test Methods (ASTM F2503): The ground truth for MR compatibility is established by the specified industry standard (ASTM F2503), which outlines the methodologies and criteria for evaluating MR safety of medical implants. The "ground truth" is adherence to and performance within the limits defined by this standard.
8. The Sample Size for the Training Set
- Not applicable. This is a performance study for MR compatibility, not an AI/machine learning study. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described study.
§ 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.