(207 days)
CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only 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 into bony voids or gaps in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone.
CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.
CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.
CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate hemihydrate and sintered hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for percutaneous injection into a bone void. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone.
The ceramic bone substitute material is injected into the bone void in a percutaneous procedure, under visual inspection or under radiographic monitoring, with the use of the accompanying injection device.
The provided text describes a medical device, CERAMENT™ BONE VOID FILLER, and its 510(k) summary for market clearance. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically understood for AI/ML-based medical devices.
The text primarily focuses on:
- Device Description: What the device is made of and how it works.
- Intended Use: The medical conditions and applications for which the device is designed.
- Predicate Device Comparison: It states that the device is "equivalent to the predicate device in intended use, technological characteristics and principles of operation."
- Regulatory Clearance: The FDA's decision of substantial equivalence.
The only mention of testing is "Extensive in vitro and in vivo testing has shown CERAMENT™|BONE VOID FILLER to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed CERAMENT™|BONE VOID FILLER to be safe and effective." This is a general statement and does not provide specific acceptance criteria or details of a study with performance metrics.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document. The questions regarding sample size, data provenance, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are also unanswerable based on this text.
§ 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.