(149 days)
The CerviFix System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Atlantoaxial fracture with instability
- Occipitocervical dislocation
- Revision of previous cervical spine surgery
- Tumors
The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical spine and occipitocervical junction (occiput - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The CerviFix System can also be linked to the Synthes Universal Spine System using the 3.5/6.0mm parallel connectors from that system.
SYNTHES CerviFix System consists of rods, plate/rods, hooks, bone screws, parallel connectors, trans-connector clamps, parallel connectors and set screws. These components are manufactured from the titanium alloy TiAINb (ASTM F1295). The bone screws are composed of commercially pure grade 4 Titanium (ASTM F67).
The rods are 3.5mm in diameter and are offered in four lengths, 80, 120, 240 and 300mm. The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod or plate/rod/hook construct. In addition, trans-connector clamps are available in a left and right version. A 3.5mm/3.5mm parallel rod connector is offered with the system. The occipital bone screws are provided in the following configurations: a 3.2mm cortex screw, a 3.5mm cancellous screw, or a 4.0mm cancellous screw.
The device functions as follows: For non occipitocervical fusion, the end of the rod, cut to an appropriate length, is inserted into the rod opening of the hooks and loosely tightened into position with the set screws included in the hooks. The construct is then positioned under the laminae of the spinal segments to be instrumented. Once the construct is compressed together, the set screws are locked down to the rod. For occipitocervical fusion, the plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.
To add a trans-connector construct, a 3.5 mm rod is cut to fit across two longitudinallyplaced 3.5 mm rods. Once the trans-connector clamps are attached to the longitudinal rods and transverse rod, the set screws are locked down to the rods. To use the parallel rod connector, two rods are inserted into the rod openings of the connector and the set screws are locked down to the rods.
The construct can also be linked to the 6.0mm diameter rods of the Universal Spine System (USS) using 3.5mm/6.0mm parallel connectors.
My apologies, but there appears to be a misunderstanding. The provided text is a 510(k) Premarket Notification for a medical device called the "Synthes CerviFix System." This document is a regulatory submission for a device line extension for an orthopedic implant, specifically for spinal fixation.
The request asks for information typically associated with studies proving the performance of an AI/software device against acceptance criteria, such as:
- A table of acceptance criteria and reported device performance (in terms of clinical metrics like sensitivity, specificity, AUC)
- Sample sizes for test sets, data provenance
- Number and qualifications of experts for ground truth
- Adjudication methods
- Multi-reader multi-case comparative effectiveness studies
- Standalone performance
- Type of ground truth (e.g., pathology, outcomes data)
- Sample size and ground truth establishment for training sets
The provided 510(k) document for the Synthes CerviFix System does not contain this type of information. It describes a physical medical device (spinal rods, plates, screws, etc.) and focuses on:
- Device Description: What the components are, their materials, and how they function.
- Indications for Use: The medical conditions the device is intended to treat.
- Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing design, materials, manufacturing processes, and performance characteristics (e.g., mechanical testing).
- Mechanical Testing: The document mentions "Mechanical testing was previously performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics and demonstrated that the performance characteristics satisfy the requirements of posterior occipitocervical and upper thoracic (Occiput-T3) fixation." This is the only mention of "testing" and it refers to mechanical (physical) testing of the implant's strength and durability, not clinical performance or diagnostic accuracy of an AI/software.
Therefore, I cannot extract the requested information from the provided text because it is not a study about an AI/software device's performance against clinical acceptance criteria. The document pertains to a physical surgical implant and its mechanical properties.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.