(28 days)
The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
The VENTURE™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile or non-sterile. The locking plate is manufactured from shape memory metal (Nitinol).
The provided text describes a 510(k) premarket notification for the VENTURE™ Anterior Cervical Plate System. This is a medical device submission seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria through performance metrics.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the submission states:
"The subject VENTURE™ Anterior Cervical Plate System components were demonstrated to be identical to the predicate ORION® Anterior Cervical Plate screw and plate components cleared in K042235 and K042499. Comparison test data were provided in support of this notification. The sole purpose of this submission was to change the trade name of a subset of the ORION® Anterior Cervical Plate System to the VENTURE™ Anterior Cervical Plate System."
This indicates that the "study" proving the device meets acceptance criteria was a comparison test demonstrating identity to a previously cleared predicate device, rather than a clinical performance study with specific metrics. The acceptance criterion was likely identical material composition, design, and function to the predicate.
§ 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.