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GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

GRAFTYS®HBS is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, 8cc of an injectable calcium-deficient apatite is athermally formed. In-vivo, this apatite which hardens in approximately 15 min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®HBS is a sterile, non-pyrogenic, single-use product.

Unfortunately, the provided document {0} does not contain information about acceptance criteria or a study proving that GRAFTYS®HBS meets specific acceptance criteria.

The document is a 510(k) summary for GRAFTYS®HBS, a resorbable bone void filler. It focuses on demonstrating substantial equivalence to a predicate device (NORIAN® SRS®) rather than presenting specific acceptance criteria and a study to prove meeting those criteria.

Here's what the document does provide:

• Intended Use: Defines the purpose of the device (bony voids/defects not intrinsic to stability, in extremities and pelvis, resorbs and is replaced by bone).
• Technological Characteristics Comparison: States that GRAFTYS®HBS has the same intended use, principle of operation, and very similar technological characteristics as the predicate.
• Non-Clinical Performance Data: Mentions in vitro and in vivo testing performed according to FDA guidance, supporting substantial equivalence. However, it does not detail these tests, their specific outcomes, or any defined acceptance criteria used for them.
• Conclusion: Claims substantial equivalence in terms of safety and effectiveness to the predicate device.

To answer your request, I would need a document that specifically outlines:

1. A table of acceptance criteria (e.g., specific metrics and thresholds for resorption rate, bone ingrowth, mechanical strength, biocompatibility, etc.).
2. Detailed results from a study designed to demonstrate compliance with those criteria.

Without such a document, I cannot fulfill your request for the tables and study details.

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