(49 days)
Synthes chronOS is intended for the repair or filling of craniofacial defects and craniotomy cuts with a surface area no larger than 25 cm². It is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas. Synthes chronOS is intended to be gently packed or placed into the site. chronOS resorbs and is replaced with bone during the healing process.
Synthes chronOS is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP). chronOS features a uniform three dimensional pore structure. Pore diameters within the material range from 100 to 500 μm. chronOS is provided sterile in granules and preformed shapes (e.g. blocks, cylinders, wedges). chronOS may be packaged with a perfusion syringe that is used to mix the bone void filler with the patient's blood components.
This document describes a 510(k) premarket notification for the "Synthes (USA) chronOSTM" device. This is a regulatory submission for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed studies on device performance against specific acceptance criteria in the way a PMA (Premarket Approval) submission would.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth establishment for a medical device algorithm or AI system is not applicable to this document.
This document focuses on:
- Device Description: Synthes chronOS is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP), with specific pore diameters.
- Intended Use: Repair or filling of craniofacial defects and craniotomy cuts (surface area no larger than 25 cm²), and restoration/augmentation of bony contours of the craniofacial skeleton.
- Substantial Equivalence: The primary "proof" in a 510(k) is demonstrating substantial equivalence to a predicate device, not necessarily meeting a new set of performance acceptance criteria through a clinical study. The predicate devices mentioned are Norian Cranial Repair System (CRS) Bone Cement and Etex α-BSM™ Bone Substitute Material for Cranioplasty.
In summary, this document does not contain the kind of performance study data you would find for an AI/algorithm-based device to establish its acceptance criteria and prove it meets them. The "study" here is the regulatory comparison to a predicate device to establish substantial equivalence.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).