(86 days)
FIBERGRAFT® AERIDYAN Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® AERIDYAN Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® AERIDYAN Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
FIBERGRAFT® AERIDYAN Matrix product is composed of 45S5 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres) and bovine type I collagen. After hydration with bone marrow aspirate (BMA), the AERIDYAN Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a nonsetting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.
This document describes a 510(k) premarket notification for a medical device called FIBERGRAFT® AERIDYAN Matrix Bone Graft Substitute. The provided text outlines the device's characteristics and its comparison to predicate devices, but does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning device.
The document discusses performance data for a bone graft substitute, which involves physical and chemical property evaluation studies, functional performance animal studies, and biocompatibility tests. These are traditional medical device testing methods, not AI/ML model validation.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for an AI/ML device based on the given text.
The information provided pertains to a physical medical device, not a digital health product with AI/ML components.
§ 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.