(36 days)
MagnetOs Easypack Putty is intended to filly bony voids or gaps of the skeletal system. i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.
MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects, MagnetOs Easypack Putty consists of 65-75% tri-calcium phosphate (TCP - Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.
New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling.
MagnetOs Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects. MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.
The provided document is a 510(k) Summary for a medical device (MagnetOs Easypack Putty) and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the context of software/AI performance.
This summary primarily focuses on demonstrating substantial equivalence to a predicate device for an expanded indication for use. It mentions general performance testing and supporting rationale, but it does not detail specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or the methodology of an AI/software performance study with a test set, ground truth, or expert involvement as requested in your prompt.
Therefore, I cannot provide the requested information based on the given text. The document describes a physical medical device (bone void filler) and its regulatory clearance process, not a software or AI-driven diagnostic or therapeutic device.
§ 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.