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The VERTICALE® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® MIS metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The subject device is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

The VERTICALE® System is a posterior fixation system for stabilizing the thoracic, lumbar and sacral spine. The VERTICALE® System is a modular, versatile fixation system consisting of pedicle screws, iliac screws, revision screws, hooks and rods for the fusion of treated spinal segments.

The pedicle screws are available in a range of sizes, and in solid, cannulated and fenestrated designs, which when used in combination with the rods, can be used for a range of indications. The pedicle screws and hooks are manufactured from titanium alloy and the rods, from titanium alloy or cobalt chrome alloy.

The VERTICALE® System comprises modular ergonomically designed, bi-functional two-in-one (2 in 1) instruments with modular handle options. The VERTICALE® System also offers a set of minimal invasive instrumentation (MIS) to facilitate minimally invasive implantation of the components.

The VERTICALE® System is color coded by diameter for ease of identification.

The VERTICALE® implants are manufactured from Ti6Al4V ELI conforming to ASTM F136 and CoCrMo conforming to ASTM F1537. The VERTICALE® System specific instruments are manufactured from materials conforming to ISO 16061 and ASTM F899.

The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.q., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

I am sorry, but the provided text is a 510(k) summary for a medical device (spinal fixation system) and does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets those criteria.

The document focuses on demonstrating substantial equivalence of the VERTICALE® Posterior Spinal Fixation System to legally marketed predicate devices through:

• Indications for Use: Matching the predicate devices.
• Technological Characteristics: Similar materials, design, and function.
• Non-Clinical Performance Data: Mechanical testing (ASTM F1717-15, ASTM F1798-13), biocompatibility (ISO 10993-1), and validation activities for cleaning, sterilization, packaging, shelf life, and transport.
• Absence of Clinical Data Requirement: Stating that due to established safety and efficacy of similar predicate devices, clinical testing was not required.

Therefore, I cannot provide the requested table or answer the specific questions about an AI/ML powered device's acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the given text.

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