(293 days)
BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hydroxyapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.
The provided text describes a 510(k) summary for a medical device called osteoSPAN Morpheus, a resorbable calcium salt bone void filler. The submission does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on:
- Technological characteristics comparison: A table comparing osteoSPAN Morpheus to a primary predicate (osteoSPAN granules) and a material-reference predicate (Actifuse ABX E-Z-fil Putty) across several characteristics (Calcium Salt, Granule Size, Porosity, Polymer Binder, Osteoconductive).
- Safety and performance testing: "Chemical and physical testing confirmed acceptable findings and were consistent with prior osteoSPAN predicate device qualifications. Biogennix osteoSPAN Morpheus was thoroughly evaluated for biocompatibility in accordance with ISO 10993 appropriate parts and for performance, through multiple non-clinical in-vivo and ex-vivo studies."
Since this is a conventional medical device submission rather than an AI/ML device, the specific questions regarding AI/ML device performance (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.
Therefore, I cannot provide the requested information from the given 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.