(389 days)
The Venus Cervical Plate System is intervertebral screw fixation of the cervical spine at levels C2-T 1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
-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
-Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
-Pseudarthrosis
-Failed previous fusion
-Decompression of the spinal cord following total or partial cervical vertebrectomy
-Spondylolisthesis
-Spinal stenosis.
The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available. The Venus Cervical Plate System configurations ranging in lengths from 17 mm to the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm for the three-level plates, , and 70 mm to 90 mm for the four -level plates. All of the plate levels incorporate blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with fixed angles available in self- tapping design. The fixed bone screws are inserted at a defined angle. The bone screws are offered in 3.5 mm, 4.0 mm and 4.50 mm diameters in lengths of 12 mm – 22 mm. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (TI6Al4V-ELI).
The Venus Cervical Plate System is intended for use as an aid in cervical spinal fusion .
The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available.
The provided text is a 510(k) summary for the Venus Cervical Plate System, a medical device for spinal fixation. It details the device's indications for use, description, non-clinical testing, and comparison to predicate devices.
However, the document does not describe:
- Acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy.
- A study proving the device meets such acceptance criteria.
- Any information regarding a test set, data provenance, expert panels, adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for diagnostic or clinical evaluation.
- Sample sizes for training sets or how ground truth for training sets was established.
The document focuses on the mechanical and material performance of the device, not its AI/software performance or diagnostic accuracy. The "Non-Clinical Testing" section describes engineering tests (e.g., Pull-out Test, Fatigue Test) to ensure the device's physical integrity and equivalence to predicate devices, which is typical for implantable orthopedic devices.
Therefore, I cannot fulfill your request for information related to AI/software performance, diagnostic accuracy, or clinical study methodologies (like MRMC studies, expert adjudication, etc.) based on the provided text. The information you're asking for would be relevant to software as a medical device (SaMD) or AI-enabled medical devices that involve image analysis, diagnosis, or prognostication, which is not what this document addresses.
§ 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.