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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.

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