(57 days)
The 3D GraftRasp System is intended to be used in orthopedic procedures to rasp or decorticate bone from the transverse processes and/or facets, and for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.
The 3D GraftRasp system contains various decortication rasps, graft pushers, a bone funnel, tools, 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 from transverse processes and/or facets. 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 text describes the 3D GraftRasp System, a medical device for orthopedic procedures, seeking 510(k) clearance from the FDA. It details device characteristics, indications for use, and a comparison to a predicate device (also the 3D GraftRasp System, K200431, from the same manufacturer).
However, the document does not contain specific acceptance criteria for a device performance study in the context of an AI/ML medical device, nor does it describe a study that proves the device meets such criteria for an AI/ML product. The performance data section focuses on non-clinical performance data for a mechanical medical device.
Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML device.
The performance data provided is for a mechanical physical device and includes:
- Biocompatibility testing: Per ISO 10993-1:2018.
- Sterilization validation: Per ISO 17665-1:2006/(R) 2013.
- Bench Testing:
- Functionality Common Material Test: Tested extrusion of various graft materials through rasps using an acceptable hand force.
- Rasp Functionality Test: Tested the rasping surface on a bone block for decortication capability without failure of teeth or main body.
- Volume Dispensing Verification Test: Tested the Graftgun for accurate bone graft dispensing with each trigger squeeze.
- Simulated Use Validation Testing: Seven studies conducted with physicians (intended users) on cadavers and/or sawbones models to simulate typical use. This aimed to gather feedback and validate the device, labeling, usability, human factors, and technique.
This information does not align with the typical requirements for describing the acceptance criteria and study proving an AI/ML device's performance.
§ 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).