(51 days)
MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities, spine and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
MicroFuse™ Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse™ is available with and without a combination of barium sulfate and calcium sulfate. MicroFuse™ is provided in a variety of shapes and sizes, in the form of granules, sheets, and pre-formed blocks. MicroFuse™ granules are designed to be gently packed into contained voids or defects. MicroFuse™ sheets are designed to be used with shallow bony defects, or as a bone graft onlay to cover a defect. MicroFuse™ blocks are designed to fill an entire defect. MicroFuse™ implants are available in short-term (ST), mid-term (MT), or long-term (LT) compositions.
The provided text is a 510(k) summary for the MicroFuse™ Bone Void Filler, which details the device's description, intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with specific acceptance criteria as might be found in a PMA (Pre-Market Approval) application or a clinical trial report for drug approval.
Therefore, I cannot provide the requested information based on the input text. The document confirms that the device was found substantially equivalent to predicate devices, allowing it to be marketed, but it does not detail specific performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to a performance study.
§ 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.