(157 days)
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed with bone during the healing process
Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.
The provided document ([K191074](https://510k.innolitics.com/search/K191074)) is a 510(k) premarket notification for a medical device called Sorrento™ Bone Graft Substitute. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Crucially, this document is a 510(k) premarket notification for a bone graft substitute, which is a physical device, and not an AI/ML-driven device. Therefore, the concepts of acceptance criteria, test sets, training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not applicable to this document. The document describes a traditional medical device approval process based on biocompatibility, bench testing, and an animal study, not an AI/ML software validation study.
Therefore, I cannot extract the requested information about acceptance criteria and study that proves an AI/ML device meets them from this document. The document does not contain information about an AI/ML device.
If you intended to provide a document related to an AI/ML medical device, please provide that document.
§ 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.