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The IlluminOss Photodynamic Bone Stabilization System is in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, pelvis, fibula, metacarpals, metatarsals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in these anatomic sites.

The IlluminOss Photodynamic Bone Stabilization System provides an important treatment option in the fixation and stabilization of fractures through a minimally invasive procedure. The system uses a catheter to deploy an inflatable, noncompliant, thin wall PET balloon into the medullary canal of the bone across the fracture site. The balloon is infused using a syringe with a photodynamic (light cured) monomer that causes the balloon to slowly expand and fill the intramedullary canal of the fractured bone. Activation of the light system allows for visible spectrum light to be delivered through a radially emitting light fiber that is temporarily positioned into a central lumen of the catheter that runs the length of the balloon. With this design, the liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. The system is currently indicated for use in the humerus, radius, ulna, clavicle, metacarpal, metatarsal, phalanges, ulna, and anterior ring of the pelvic. The purpose of this Special 510(k) is to expand the indications for use to include the fibula.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the IlluminOss Photodynamic Bone Stabilization System.

It includes:

• Device Name and Regulation Information: IlluminOss Photodynamic Bone Stabilization System, regulated as an in vivo cured intramedullary fixation rod (21 CFR 888.3023).
• Clearance Date and Reference Number: August 13, 2020, K201961.
• Indications for Use: Treatment of traumatic, fragility, pathological, and impending pathological fractures of humerus, radius, pelvis, fibula, metacarpals, metatarsals, and phalanges, and as supplemental fixation.
• Predicate Device Information: The device is deemed substantially equivalent to the Synthes Elastic Intramedullary Nail System (K081452). A previously cleared IlluminOss system (K200295) is also referenced for expanding indications to the fibula.
• Device Description: Details on how the system works (inflatable PET balloon, photodynamic monomer, light curing).
• Performance Testing Summary (brief): States that testing demonstrates "sufficient strength upon curing for the fibular indications."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number/qualifications of experts, or adjudication methods for any test set or ground truth establishment.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Specific types of ground truth used (e.g., pathology, outcomes data).
• Training set size or how its ground truth was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

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