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The VERTICALE® GPS Instruments are indicated to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS™ system, which is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

VERTICALE GPS Instruments are non-sterile, reusable instruments including awls, drills, taps, probes, burrs, and screw drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of Silony Medical pedicle screws (VERTICALE Posterior Spinal Fixation System and VERTICALE Cervical System). The instruments are manufactured from medical grade stainless steel.

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The Sovereign Posterior Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Sovereign Posterior Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system's Instructions for Use for a list of indications for use for each system.

The Met One Technologies Sovereign Posterior Cervical System is an implant device designed for the posterior stabilization of the cervical and upper thoracic spine. The system includes implants such as polyaxial screws, blocker screws, rods, crosslinks, lateral connectors, and rod to rod connectors to form a unique construct to match patient anatomy.

Polyaxial screws are offered in a range of sizes in both standard and reduction tulips for ease of use. All screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Straight, pre-bent, and transition rods are offered in 3.5mm and 4.0mm diameters and in two different materials, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome (Co-Cr28-Mo6 per ASTM F1537). Transition rods are fully compatible with Met One Technologies Xultan 5.5 Pedicle Screw System line of implants.

A variety of connectors and crosslinks are offered for surgeons to create the desired construction. Rod to rod crosslinks improve the torsional stability of the construct. Lateral connectors are provided in open and closed configurations, 3.5mm and 4.0mm diameters, and in long and short lengths. Rod to rod connectors are offered in several configurations to join rods together. All connectors are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

I am sorry, but the provided text is an FDA 510(k) clearance letter for a Sovereign Posterior Cervical System, which is a physical medical device (spinal implant system), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/SaMD's performance.
• A study proving the device meets AI/SaMD acceptance criteria.
• A test set (sample size, provenance).
• Experts establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth.
• Training set details.

The non-clinical testing described (ASTM F1717 and ASTM F1798) refers to mechanical testing of the physical implant's strength and durability, not software performance.

As such, I cannot fulfill your request for information related to AI/SaMD acceptance criteria and study details based on the provided input.

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