(103 days)
The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.
The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannula applicator tip and two caps. The device is provided sterile, for single use only.
The provided documents describe the InFill™ Graft Delivery System and its substantial equivalence to a predicate device. However, the documents do not contain information related to an AI device or an AI-driven study.
Therefore, I cannot answer the specific questions about acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI device.
The information provided only describes a traditional medical device (a piston syringe for bone graft delivery) and its regulatory clearance based on performance tests like:
- Simulated Use Testing
- Volume Verification
- Separation Force Testing
- Liquid Leak Testing
- Biocompatibility Testing
The document states: "The modified InFill™ Graft Delivery System met all specified criteria and did not raise new safety or performance questions." This implies that the acceptance criteria were defined for each of these tests, and the device successfully passed them. However, the specific quantitative acceptance criteria or the detailed reported performance values for each test are not provided in the given text.
In summary, this submission is for a conventional medical device and lacks the AI-specific information requested in the prompt.
§ 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).