(60 days)
FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG 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® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.
The provided text is a 510(k) summary for the FIBERGRAFT® BG Matrix Bone Graft Substitute. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device performance study.
Instead, the document details performance testing for a bone graft substitute, which involves:
- Physical and chemical property evaluation studies.
- Functional performance animal studies (specifically, a rabbit study comparing the device to a predicate and controls).
- Biocompatibility tests (ISO 10993).
- Packaging evaluations, shelf life, and real-time aging testing.
- Bacterial endotoxin testing.
The document states that the rabbit study evaluated device performance using "radiographic, histological, histomorphometric, and biomechanical data" and concluded that the device performs "substantially equivalently to the predicate device and positive control."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it relates to an AI/ML device. The document is for a medical device (bone graft substitute), not an AI/ML algorithm.
If you can provide a document describing a clinical study or performance evaluation for an AI/ML medical device, I would be happy to help answer your questions according to the format you've provided.
§ 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.