(296 days)
OssiPro Bone Substitute Material is intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, spine, and the 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. OssiPro is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
OssiPro Bone Substitute Material is an injectable synthetic, biocompatible bone graff substitute material. It is intended for use in bone void filler applications in the spine, pelvis, and extremities. At the time of use, OssiPro is combined with the hydration solution and is mixed to a smooth consistency. The material can be delivered to the defect site by injection with provided syringe or with desired needle/cannula (not provided). After delivering the paste to the treatment site, it forms pores while hardening at body temperature and converts to a macro-porous, poorly crystalline hvdroxvapatite (PCHA) scaffold. The end product has a similar chemical identity and crystalline structure to that of natural bone. OssiPro Bone Substitute Material is an osteoconductive bone graft substitute that resorbs and is replaced with new bone over time.
This document outlines the 510(k) submission for the OssiPro Bone Substitute Material. It does not contain information about acceptance criteria or a study proving that a device (in the sense of a diagnostic or AI-driven system) meets acceptance criteria. Instead, it details the characteristics and intended use of a bone substitute material and asserts its substantial equivalence to previously marketed predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and a study from the given text because it is not a study about device performance against acceptance criteria in the manner described (e.g., for a diagnostic tool or AI).
The document is a regulatory submission for a medical device (bone substitute material) and focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study against predefined acceptance criteria for a diagnostic/AI device.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.