Search Results

OssiFuse 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 (such as the extremities, 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. OssiFuse Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

OssiFuse Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in bone void filler applications in the spine, pelvis, and extremities. At the time of use, the OssiFuse powder component is combined with the mixing liquid and is mixed to form a paste. Mixing is facilitated by a syringe to syringe mixing system. The resulting paste can be administered to the treatment site by manual application or injection, and can be shaped in situ or into a desired form prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of the mineral content of natural bone, OssiFuse Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

This submission is for a bone substitute material, not an AI/ML powered medical device. Therefore, the requested information about acceptance criteria for device performance, types of studies, sample sizes, expert involvement, and ground truth establishment, which are specific to AI/ML device evaluations, are not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the OssiFuse Bone Substitute Material to a predicate device (CaP3 Bone Substitute Material) based on similarities in intended use, chemical composition, and fundamental scientific technology. Regulatory information and manufacturing compliance are also mentioned.

Table of Acceptance Criteria and Reported Device Performance: Not applicable for this type of medical device submission. The submission indicates the device is substantially equivalent to a predicate device, meaning its performance is expected to be similar to a previously cleared device.

Sample size for test set and data provenance: Not applicable. This refers to AI/ML model testing, not a bone substitute material.

Number of experts used to establish ground truth and qualifications: Not applicable.

Adjudication method: Not applicable.

Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.

Standalone (algorithm only) performance: Not applicable.

Type of ground truth used: Not applicable.

Sample size for training set: Not applicable.

How ground truth for training set was established: Not applicable.

Ask a specific question about this device