(38 days)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.
The Trestle Luxe Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- spondvlolisthesis .
- trauma (i.e., fracture or dislocation) ●
- spinal stenosis .
- . pseudoarthrosis
- . tumor
- and failed previous fusion. .
The Trestle Luxe Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws.
The provided text describes the Trestle Luxe Anterior Cervical Plating System, a medical device for spinal stabilization. However, it does not contain information about acceptance criteria, performance studies, sample sizes, expert ground truth, or adjudication methods in the context of device performance in a clinical or AI-related study.
The document is a 510(k) summary for a medical device (surgical implant), not for an AI/ML medical device. Therefore, the questions related to AI/ML device performance, such as multi-reader multi-case studies, standalone algorithm performance, training set details, and specific ground truth establishment for such studies, are not applicable to this document.
The document primarily focuses on establishing "substantial equivalence" to predicate devices based on:
- Intended Use and Function: Compared to existing spinal plating systems.
- Technological Characteristics: Material (titanium alloys), design (integrated screw locking mechanism), and general components (bone screws).
- Nonclinical Performance Data: References prior mechanical resting performed for a previous 510(k) submission (K071380) and adherence to recognized consensus standards and guidance documents for spinal systems. This mechanical testing established static and fatigue performance, demonstrating suitability for anterior cervical fixation.
Therefore, I cannot fulfill your request as the input document does not contain the necessary information regarding acceptance criteria and a study proving device performance in the manner you've outlined for an AI/ML device.
The document does include:
- Device Description: The Trestle Luxe Anterior Cervical Plating System is a temporary device to stabilize the cervical spine during bone fusion development.
- Indications for Use: For anterior cervical decompression and fusion (ACDF) surgery (C2-C7) for conditions like DDD, spondylolisthesis, trauma, spinal stenosis, pseudoarthrosis, tumor, and failed previous fusion.
- Predicate Devices: K070681 (Next Generation (Trestle) Anterior Cervical Plating System), K013877 (Slim-Loc System), K061274 (Venture Anterior Cervical Plate System).
- Regulatory Information: 510(k) Number K102820, Class II, Product Code KWQ.
§ 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.