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OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed with host bone during the healing process. When used in intervertebral body fusion procedures. OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

OsteoFlo HydroFiber is a resorbable bone void filler comprised of calcium phosphate, bioglass, in a synthetic polymer binder. The OsteoFlo HydroFiber is intended to be easily packed into osseous defects. The single-use device is supplied sterile and dry. The device requires mixing with aqueous solution (autograft, saline, or bone marrow aspirate) prior to use. OsteoFlo HydroFiber may be used as standalone, equivalent to autograft, or in conjunction with autograft.

The provided text is a 510(k) summary for the OsteoFlo HydroFiber device. It outlines the device's indications, description, and comparison to predicate devices, focusing on demonstrating substantial equivalence based on non-clinical performance testing.

However, the document does not contain any information regarding clinical studies or the performance of an AI/software device. Therefore, I cannot provide details on acceptance criteria, expert adjudication, MRMC studies, standalone performance, or ground truth establishment as requested.

The document primarily focuses on non-clinical performance testing for a bone void filler, which includes:

• Biocompatibility per ISO 10993-1:2018
• Sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013
• Packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006
• Shelf-life testing per ASTM 1980-16
• Material characterization (x-ray diffraction, particle size, particle porosity and surface area)
• In vivo evaluation in a Lapine Posterolateral Fusion Model

Without information regarding an AI/software component or human reader studies, I cannot fill out the requested table or answer the specific questions related to AI device performance.

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