(156 days)
OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the extremities, pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
The OsteoFlo® HydroFiber™ is a resorbable bone void filler designed to be placed in bony defects, either surgically created (i.e., tumor removal), or the result of traumatic injury. The single-use device is supplied sterile and dry. The device requires mixing with aqueous solution (autograft, saline, blood, or bone marrow aspirate) prior to use. OsteoFlo HydroFiber may be used as standalone, equivalent to autograft, in conjunction with autograft, or as a bone graft extender.
It appears there's a misunderstanding. The provided FDA 510(k) clearance letter for the OsteoFlo HydroFiber device is for a Resorbable Calcium Salt Bone Void Filler Device, which is a physical implantable device.
The request asks for information typically associated with AI/ML-based medical devices, particularly regarding:
- A table of acceptance criteria and reported device performance (often including metrics like sensitivity, specificity, AUC for AI models)
- Sample sizes for test sets, data provenance
- Expert involvement for ground truth establishment (e.g., radiologists for image interpretation)
- Adjudication methods
- Multi-reader multi-case (MRMC) studies
- Standalone performance (algorithm only) vs. human-in-the-loop performance
- Types of ground truth (e.g., pathology, outcomes data)
- Training set sample size and ground truth establishment
The provided FDA letter does not contain any information related to AI/ML software performance or studies. Instead, it lists non-clinical performance data for a physical medical device, such as:
- Biocompatibility
- Sterilization validation
- Packaging validation
- Shelf-life testing
- Endotoxin validation
- Material characterization
- Dimensional stability assessment
- In vivo evaluation (Rabbit Metaphyseal Defect Model)
- Pyrogenicity Testing
Therefore, I cannot fulfill your request based on the provided text, as the document describes the clearance of a physical bone void filler, not an AI/ML software device. The acceptance criteria and performance studies mentioned in the document are for the physical properties and biological interactions of an implantable material, not for the diagnostic or analytical performance of an AI algorithm.
§ 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.