(130 days)
CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
CERAMENT | BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone.
CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process.
CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.
CERAMENT| BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains iohexol as a radio-opacification enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo.
By combining hydroxyapatite and calcium sulfate, an optimal balance is achieved between implant resorption rate and bone ingrowth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone ingrowth and gives long term structural support to the newly formed bone.
The ceramic bone graft substitute is placed into the bone defect under direct visualization or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate filling the bone defect.
When fully set in vivo, CERAMENT | BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure.
This document describes the regulatory submission for CERAMENT BONE VOID FILLER, a medical device, and its acceptance criteria as defined by the FDA. However, it does not describe acceptance criteria for an AI device's performance or a study proving an AI device meets those criteria.
Therefore, I cannot fulfill the request as it pertains to an AI device. The provided text is a 510(k) submission for a bone void filler and does not contain information about AI device performance testing, ground truth establishment, or clinical study methodologies for AI.
The closest relevant information is a statement about the device meeting "pre-determined acceptance criteria identified in the Design Control Activities Summary," but the document does not provide details about those specific acceptance criteria beyond general biocompatibility and mechanical properties for a bone void filler. It also mentions "Performance Testing" was previously provided, but again, the specifics of these tests and their results are not detailed in this submission.
§ 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.