(439 days)
Synthes chronOS is intended for use as a bone void filler in voids or gaps that are not intrinsic to the stability of the bony structure. chronOS is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
chronOS is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold 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 510(k) premarket notification for Synthes chronOS, a bone void filler, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning that the FDA determined it is as safe and effective as existing devices. This type of regulatory submission typically relies on comparisons to well-established devices rather than extensive new clinical performance studies with specific acceptance criteria that would be detailed in the submission.
§ 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.