(101 days)
Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput -T3), the plate/rod, rod, hook and screw (3.2mm cortex, 3.5mm and 4.0mm cancellous) components of the Synthes CerviFix System are 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 .
- atlanto axial fracture with instability
- occipitocervical dislocation .
- revision of previous cervical spine surgery
- . tumors
When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods. Clamps and Screws
The rods, clamps and screws are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3)
The use of these screws (3.5mm cancellous, 4.0mm cancellous, 4.0mm and 4.35 expansionhead) is limited to placement in T1 -T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The CerviFix System can also be linked to the Synthes Universal Spinal System using the 3.5/6.0mm parallel connectors from that system.
Synthes CerviFix System consists of rods, plate/rods, clamps and bone screws. The hooks, clamps, rods and plate/rods are composed of the titanium alloy Ti6Al7Nb (ASTM F1295). The screws are composed of commercially pure grade 4 Titanium (ASTM F67).
This K990965 document is a 510(k) summary for the Synthes CerviFix System, a medical device for spinal fusion. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a summary for a 510(k) application, not a clinical trial report.
Based on the provided document, the following information is available or can be inferred:
-
A table of acceptance criteria and the reported device performance:
Not provided in this 510(k) summary. A 510(k) primarily focuses on demonstrating substantial equivalence to a predicate device, often through comparison of indications for use, technological characteristics, and performance data if available (e.g., mechanical testing for spinal implants). Specific clinical acceptance criteria and performance metrics from a study are typically not included in this type of summary unless they were used for a specific performance test demonstrating equivalence. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided. This document explicitly states, "The Synthes CerviFix System is substantially equivalent to itself." This implies that the basis for equivalence is likely a modification or rebranding of an existing device, or perhaps a component within an existing system, rather than a de novo clinical study with a test set of human patients. For spinal implants, performance data often comes from mechanical testing, not human clinical trials for a 510(k). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical test set for ground truth establishment is described. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication is described. -
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 device is a mechanical spinal implant, not an AI-driven diagnostic or therapeutic tool for which an MRMC study would be relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical spinal implant, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical study requiring a ground truth is described. For spinal implants, "ground truth" might refer to successful fusion rates observed in clinical use of similar devices, or adherence to biomechanical performance standards, but this document does not detail such studies. -
The sample size for the training set:
Not applicable. This device is a mechanical spinal implant, not a machine learning model requiring a training set. -
How the ground truth for the training set was established:
Not applicable.
In summary:
The provided K990965 document is a regulatory submission demonstrating substantial equivalence for a medical device (spinal implant). It is not a report of a study that establishes acceptance criteria through clinical performance or provides data on device performance against specific criteria, especially not in the context of diagnostic accuracy or AI. The focus is on the device's indications for use and its components, and its substantial equivalence to a predicate device (implicitly, itself, suggesting a modification or re-filing).
§ 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.