(269 days)
MaxiGen™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process
MaxiGen™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with calcium sulfate and carboxymethylcellulose (CMC). MaxiGen™ comes in the form of a kit with a premeasured and premixed DBM, calcium sulfate, and CMC powder, premeasured mixing solution, the tools for mixing the components, and a 5cc syringe. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids, or it can be injected using the syringe supplied in the kit. This product is supplied sterile for permanent resorbable device, implanted in bone tissue.
The provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "MaxiGen™," which is a resorbable calcium salt bone void filler. It describes the device's indications for use, materials, testing for biocompatibility and performance (osteoconduction and osteoinduction), and comparison to predicate devices, but it does not involve any AI technology or related performance metrics.
Therefore, I cannot provide the requested information.
§ 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.