(87 days)
The 3D GraftRasp System is intended to be used in orthopedic procedures to rasp or decorticate bone and for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
The 3D GraftRasp system contains various decortication rasps, graft pushers, a bone funnel, and dilators. The 3D GraftRasp system is compatible with the Graftgun Universal Graft Delivery System for graft delivery to the surgical site. The decortication rasps can be used to rasp or decorticate bone. After rasping, a 5cc or 7.5cc graft tube can be inserted into the rasp lumen to extrude graft from the tip of the rasp. A set of optional sequential dilators and rasp pushers may also be provided to aid in the use of the decortication rasp. A bone funnel may optionally be used to extrude graft through the rasps instead of the graftgun.
The provided document is a 510(k) Summary for a medical device called the "3D GraftRasp System." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.
The document discusses the substantial equivalence of the 3D GraftRasp System to predicate devices based on technological characteristics and non-clinical performance data (biocompatibility, sterilization validation, and bench testing). The bench testing includes:
- Functionality Common Material Test: Verifies the Graftgun can successfully extrude various graft materials through the different rasps of the 3D GraftRasp System.
- Rasp Functionality Test: Confirms the rasping surface can decorticate a bone block without failure.
- Volume Dispensing Verification Test: Ensures the Graftgun dispenses an accurate amount of bone graft.
However, the nature of the device (a piston syringe and bone rasp) and the tests described align with a traditional medical device submission, not an AI/ML-powered device. Therefore, the specific information requested, such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable or present in this document.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).