(71 days)
The ACLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthosis, and deformity (defined as kyphosis, lordosis and scoliosis).
The ACLP System is an addition to Synthes' existing Anterior Cervical Vertebrae Plate System (Anterior CSLP). The ACLP System is composed of plates and screws which are made from titanium allov Ti-6Al-7Nb (ASTM F1295). These plates attach to the anterior cervical spine with a minimum of four screws per plate.
The plates range in length to accommodate one, two, three, and four level procedures. The plates in the system are pre-lordosed to accommodate the cervical spine minimizing the need for the surgeon to manually bend the plates.
The screws in the ACLP System are 4.0mm and 4.5mm conical head screws. They are self-drilling and self-tapping in both cancellous and cortical thread profiles and are available in lengths ranging from 12mm to 16mm.
The provided text is a 510(k) summary for the Synthes Anterior Cervical Locking Plate (ACLP) System. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device. However, it does not include any information regarding acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for diagnostic devices or those involving AI/software.
Therefore, I cannot provide the requested information from the given text.
The provided document is a regulatory submission for a physical medical device (spinal implant), not a software or AI-driven diagnostic device that would typically have performance metrics like sensitivity, specificity, or accuracy that are established through specific studies with ground truth. The "acceptance criteria" for such a device are primarily related to mechanical testing, biocompatibility, and substantial equivalence to a legally marketed predicate device, rather than performance metrics on a dataset of patient images or conditions.
Key Reasons why the requested information cannot be found in the provided text:
- Type of Device: The ACLP System is a physical implant (plates and screws for spinal fixation), not a diagnostic algorithm or AI-powered system that analyzes data.
- Nature of 510(k) Submission: A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. For physical implants, this often involves comparing materials, design principles, indications for use, and sometimes results from mechanical or in-vitro testing to show equivalent safety and effectiveness. It does not typically involve large-scale clinical trials or performance studies against a "ground truth" as you would see for AI devices.
- Missing Sections: The document focuses on the device description, indications for use, and the FDA's regulatory decision. It lacks sections detailing performance studies, statistical analyses, or human reader performance evaluations.
§ 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.