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Kasios TCP is indicated only for filling bone voids or defects that are not intrinsic to the stability of the bony structure. Kasios TCP is to be gently packed into bony voids or gaps of the skeletal system (such as the extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Kasios TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.

The KASIOS TCP is a synthetic resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.

This submission is a 510(k) premarket notification for a medical device called "Kasios TCP," a synthetic resorbable calcium phosphate bone void filler. The purpose of a 510(k) is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not to establish new performance criteria through clinical trials or specialized studies that define acceptance criteria or measure performance against them.

Therefore, the provided text does not contain information on:

• Acceptance Criteria and Reported Device Performance: There is no table of acceptance criteria or reported device performance metrics. The submission focuses on demonstrating substantial equivalence to predicate devices, not on proving specific performance targets.
• Study Details: There are no details on sample sizes, data provenance, number or qualifications of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance studies. These types of studies are typically found in PMAs (Premarket Approval applications) or sometimes in more extensive clinical studies supporting 510(k)s that address specific performance aspects, but they are not present here.
• Ground Truth: The type of ground truth used, how it was established for training sets, or the sample size for training sets are not mentioned.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence, not a study report detailing acceptance criteria and performance data.

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