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CITREPORE™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CITREPORE is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. CITREPORE is intended to be used for filling bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, CITREPORE resorbs and is replaced with bone during the healing process.

CITREPORE™ is a synthetic, highly porous, resorbable bone void filler fabricated from a polymer bioceramic composite comprised of 60 wt.-% polymer and 40 wt.-% ASTM F1538 4555 Bioactive Glass. The polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. Bioactive Glass is a biologically compatible synthetic material consisting of silicates, sodium oxides, and phosphates. The constituent materials (citrate, Ca, P, O, H, Si) exist naturally in normal bone.

CITREPORE is provided to the end user in a variety of shapes and sizes that facilitates new bone formation across the graft site and throughout the interconnected porous structure. CITREPORE is pliable and sponge-like and can be cut to fit the bony defect using traditional instruments that are available in the OR at the time of surgery. At the time of surgery, CITREPORE can be infused with autologous blood, bone marrow aspirate, and/or other fluids. As body fluids penetrate the device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites. Upon implantation, the Bioactive Glass component of CITREPORE undergoes a surface modification that provides for direct bonding to surrounding bone via an apatite layer (i.e., bioactive). CITREPORE is single use and provided sterile.

MATERIALS: POC (poly-octamethylene-citrate) and ASTM F1538 4555 Bioactive Glass.

The provided text is a 510(k) premarket notification for a medical device called "Citrepore™", a resorbable bone void filler. It details the device's characteristics, intended use, and a comparison to a predicate device, along with performance data. However, this document does not describe a study involving an AI/Software as a Medical Device (SaMD) and therefore does not contain the specific information requested in the prompt regarding acceptance criteria and performance of such a device, human readers, or expert adjudication for ground truth of a test set.

The performance data section describes typical testing for a physical medical device (like biocompatibility, osteoconductivity in an animal model, porosity, etc.), not the AI/SaMD related metrics such as sensitivity, specificity, or reader study outcomes.

Therefore, I cannot extract the information required to populate the table or answer the specific questions about an AI/SaMD study, as this document pertains to a physical bone void filler device.

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