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The VENUS BASIC Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graff having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the VENUS BASIC Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

The VENUS BASIC Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism.

The VENUS BASIC Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. VENUS BASIC Spinal Fixation System implants components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

The purpose of this submission is to add components of the cannulated polyaxial pedicle screws in VENUS BASIC Spinal Fixation System. Various sizes of these implants are available.

The provided text is a 510(k) summary for the VENUS BASIC Spinal Fixation System. This type of submission is for medical devices seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics typically associated with AI/ML-driven devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML algorithm's performance.

Instead, this document focuses on:

• Device Identification: Trade name, common name, classification, and product codes.
• Predicate Devices: Listing of previously cleared devices to which the current device claims substantial equivalence.
• Device Description: What the device is (posterior spinal fixation system) and its components (pedicle screws, rods, set screws, transverse linking mechanism). It also mentions the purpose of the submission is to add cannulated polyaxial pedicle screws.
• Indications for Use: The medical conditions and patient populations for which the device is intended.
• Performance Data (Mechanical Testing): States that mechanical testing was conducted according to ASTM F 1717 to demonstrate equivalence to predicate devices in terms of static compression/tension/torsion and fatigue. This is a common requirement for spinal implants but is not a clinical study proving performance against defined acceptance criteria for AI/ML.

In summary, none of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, or MRMC/standalone performance relevant to an AI/ML device is present in this 510(k) summary.

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