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TriPore HA, TriPore BP90, TriPore BP15, is a synthetic bone graft intended to be packed into bone defects of the sketal system (extremities, posterolateral spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Synthetic bone graft granules of one of the following three materials packed in a multi-purpose applicator (MPA):
(A) 100% pure hydroxylapatite (TriPore HA)
(B) biphasic mixture of 90% hydroxyapatite and 10% tri-calcium phosphate (TriPore BP90)
(C) biphasic mixture of 15% hydroxyapatite and 85% tri-calcium phosphate (TriPore BP15)

I'm sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for a medical device (synthetic bone graft) and primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general information about the device. It does not describe any specific study that proves the device meets acceptance criteria, define acceptance criteria, or provide details about a performance study with sample sizes, expert involvement, adjudication, or ground truth establishment.

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