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Cementek® LV is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® LV is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be injected into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gaps, Cementek® LV resorbs and is replaced with bone during the healing process.

As an injectable bone substitute, Cementek® LV is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced with a syringe into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in an apatitic calcium phosphate cement. Cementek® LV is marketed in a 16cc dosage.

The provided text is a 510(k) summary for the Cementek® LV bone substitute, a medical device. It does not describe acceptance criteria or a study proving that a device meets such criteria for an AI/ML-based medical device. Instead, it details the device description, intended use, and a summary of technological characteristics compared to a predicate device for a physical medical device (bone void filler).

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, device performance, study details for AI/ML devices, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided document.

The document discusses substantial equivalence for a physical product based on comparing its characteristics to a predicate device, not the performance of an algorithm or an AI system.

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