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IGNITE™ Bone Graft products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE™ Bone Graft products are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The bone graft syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.

The IGNITE™ powder is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose. The IGNITE™ powder is intended to be mixed with bone marrow aspirate (BMA) to form an injectable paste for implantation.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the IGNITE™ Bone Void Filler in the format requested. The document is a 510(k) summary for a medical device (IGNITE™ Bone Void Filler) and primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical evidence.

Here's a breakdown of what the document does say, and why it doesn't directly answer your questions:

• No detailed acceptance criteria or performance study: The document states, "A mixing equivalency evaluation of the subject system was performed in bench top testing. Pyrogenicity testing was also performed. The subject syringe mixing and delivery systems are acceptable methods for the preparation of the IGNITE™ Bone Void Filler." This is a very high-level summary of non-clinical testing. It does not provide specific acceptance criteria values (e.g., "mixing time

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