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The GUARDIAN-SG Inflatable Bone Expander System is intended to the reduction and fixation of fractures and/or creation of a void in cancellous bone in this includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The GUARDIAN-SG Inflatable Bone Expander System (IBES) is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN-SG IBES are the significant reduction in back pain and increase patient`s functional abilities, allow a return to the previous level of activity.

The GUARDIAN-SG IBES components are Inflatable Bone Tamp (balloon catheter, compressor) and accessory kit. And balloon catheter' main components are the shaft, Yhub and the inflatable balloon located at the distal tip and inflatable balloon is covered maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning.

The Balloon catheter, compressor and the accessory kit are supplied sterile and disposable use.

This document is related to a 510(k) premarket notification for the GUARDIAN-SG Inflatable Bone Expander System. It does not contain information about acceptance criteria, device performance, a study proving acceptance criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or training set details.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design, and use concept. It mentions that "The GUARDIAN-SG Inflatable Bone Expander System met the specifications and performance characteristics" and that "testing included functional, such as balloon compliance, deflation time, insertion / withdraw force and fatigue testing as well as mechanical testing, such as tensile strength." However, it does not provide the specific acceptance criteria for these tests or the detailed results of the tests themselves.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about a study proving the device meets acceptance criteria. The provided text does not contain that level of detail.

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