(18 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, posterolateral spine (only during open surgery in spine), and intervertebral disc space. 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. When used in intervertebral body fusion procedures, CERAMENT BONE VOID FILLER must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
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 composed of hydroxyapatite, calcium sulfate hemihydrate, and calcium sulfate dihydrate, and it identical to the device cleared in K201535. This submission expands the device's indication to include use in the intervertebral space.
The provided text is a 510(k) premarket notification approval letter for the Cerament Bone Void Filler. This document does not describe a study involving an AI/software device that requires acceptance criteria, a test set, expert readers, or MRMC studies.
Instead, it pertains to a medical device (a bone void filler) and its substantial equivalence to predicate devices, focusing on:
- Its material composition (hydroxyapatite, calcium sulfate hemihydrate, and calcium sulfate dihydrate).
- Its indications for use (filler for gaps and voids, including intervertebral disc space, with specific conditions).
- Performance aspects like sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and bench performance, which were leveraged from a previous clearance (K201535).
- A "robust analysis of bone grafting materials in the prior posterolateral spine fusion studies" is mentioned, but this refers to a biological material's performance in an animal model, not the performance of an AI algorithm or a software device.
Therefore, the information requested in your prompt (acceptance criteria for a device, test set details, expert ground truth, MRMC study, standalone performance, etc.) is not present in the provided text as it is not relevant to the type of device (a bone void filler) being discussed.
§ 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.