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Gamma-bsm Moldable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxylapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

The provided text is a 510(k) summary for the Gamma-bsm Moldable Bone Substitute Material. This document focuses on the regulatory submission for a medical device and does not contain information typically found in a study proving a device meets acceptance criteria for an AI/software-as-a-medical-device (SaMD) product.

The request asks for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, including details like sample sizes for test and training sets, expert qualifications, and adjudication methods. These types of details are not relevant to the physical bone void filler device described in the provided 510(k) summary.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving the device meets those criteria, as the provided text relates to a physical medical device (bone void filler) and not a software/AI product. The submission is a "Traditional 510(k) Submission - Bone Void Fillers" and its performance data section refers to "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003)". This indicates the type of testing performed would be for a physical material's properties (e.g., biocompatibility, mechanical strength, resorption rate) rather than performance characteristics of an AI algorithm.

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