(147 days)
The Small Stature Anterior Cervical Vertebrae Plate System (as part of the Anterior Cervical Vertebrae Plate System) is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:
- Spondylolisthesis
- Fracture
- Spinal stenosis
- Tumor
The Synthes Small Stature Anterior Cervical Vertebrae Plate consists of a plate with at least 4 screws and is manufactured from CP titanium. The plate has 6° of angulation, is available in lengths from 20mm is 2mm thick and is 16.49mm wide. The 20mm - 26mm plates have four holes: the 34mm - 47mm plates have six holes. 30mm -59mm have eight holes. and 62mm has 10 holes . The plate accepts a 3.5mm cancellous screw. a 3.5mm corex screw, or a 4.0mm or 4.35mm expansion screw with 1.8mm locking screw. The expansion screws provide a locking mechanism to reduce the risk of the screw backing out with subsequent loss of fixation. It is inserted (screwed) into the bone through the plate, and tightened until the screw head is fully seated in the plate. The 1.8mm locking screw is then inserted into the expansion screw by way of the mating threads (1.8mm). As the locking screw is tightened, the conical head of this screw engages the conical bore in the head of the expansion screw. In addition to the conical bore, the head of the expansion screw is slotted so that further tightening of the locking screw serves to expand the four sections of the expansion screw head outward. This outward (radial) expansion of the expansion screw head results in a locking force created between the screw and the plate. Implant removal is accomplished in the reverse order. The device functions as follows: The placed on the anterior aspect of the vertebral body of the cervical spine by inserting a 3.5mm cancellous screw, a 3.5mm cortex screw, or a 4.0mm or 4.35mm expansion screw with 1.8mm locking screw through the cephalad holes and into the vertebral body. The screws, or expansion screws with locking screws are then inserted into the caudal holes in the plate and inserted into the vertebral bodies of the cervical spine. It is manufactured from CP titanium, which conforms to ASTM Standard F67. This system is provided non-sterile; moist heat sterilization is recommended.
The provided text is a 510(k) summary for a medical device: the SYNTHES Spine Small Stature Anterior Cervical Vertebrae Plate System. It details the device's indications for use and compares it to a predicate device for substantial equivalence.
However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/software devices. This document is a regulatory submission focused on substantial equivalence of a physical implant (a spinal plate system), not an AI or software device. As such, many of the requested categories (like sample size for test/training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance) are not applicable or present in this type of submission.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this text, nor can I fill in the details for a study that proves it meets those criteria in the context of an AI/software device.
The information that can be extracted relates to the device's intended use and the regulatory finding of substantial equivalence:
Device: SYNTHES Spine Small Stature Anterior Cervical Vertebrae Plate System
Intended Use/Indications:
Anterior screw fixation to the cervical spine (C2-C7) for:
- Spondylolisthesis
- Fracture
- Spinal stenosis
- Tumor
Regulatory Finding: Substantially equivalent to the Synthes Anterior Cervical Vertebrae Plate System (K945700 & K926453).
Regarding the specific questions posed:
- A table of acceptance criteria and the reported device performance: Not applicable/not present in this type of document. The regulatory pathway here is substantial equivalence to a predicate, not performance against specific, quantifiable acceptance criteria in the manner of an AI/software device.
- Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI model evaluated on a data set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, doesn't apply to this physical device submission.
- Adjudication method: Not applicable.
- 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: Not applicable. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used: Not applicable. The "ground truth" for this device revolves around its material properties (conforming to ASTM Standard F67 for CP titanium), mechanical design, and clinical indications being similar to the predicate device.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance data from a clinical trial or AI model validation study. The "study" here is implied by the comparison to the predicate device and adherence to material standards.
§ 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.