(267 days)
The Allograft Delivery Device is intended to be used for the delivery of hydrated allograft to an orthopedic surgical site.
The Allograft Delivery Device is a sterile, single-use, disposable allograft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery device consists of a cannula used for containing and delivering the allograft material to the surgical site and a push rod required for expressing the allograft material from the cannula.
The cannula component is an open bore tube with a male double-threaded lock interface that mates with a pre-existing allograft syringe. The cannula component may be used to dispense allograft to a patient orthopedic surgical site. When used as an ancillary device to orthopedic surgical procedures that require the placement of allograft Delivery Device can deliver a prepared amount of allograft material.
The provided document is a 510(k) summary for the Allograft Delivery Device (OFAC-C), which is a medical device and not an AI/ML-driven software. Therefore, the document does not contain information typically associated with AI/ML device testing and acceptance criteria, such as diagnostic performance metrics (e.g., sensitivity, specificity, AUC), clinical study designs (e.g., MRMC studies), ground truth establishment by experts, or training/test set details for AI algorithms.
The acceptance criteria and supporting studies presented in this document are focused on the physical and biological performance of a medical device (a delivery syringe), not an AI algorithm. The performance data provided relates to:
- Sterilization and Shelf-life: Validation that the device remains sterile and functional over time.
- Biocompatibility Testing: Confirmation that the device materials are safe for human contact.
- Functional Verification: Mechanical tests to ensure the device operates as intended (e.g., cannula buckling, plunger force, connection strength, no fluid separation, durability, push rod function).
- Shipping/Transit: Testing to ensure the device withstands transport conditions.
- Usability Testing: Evaluation of how easily and effectively users can safely operate the device.
Since the request asks for details specific to AI/ML device evaluation, and this document pertains to a physical medical device, I cannot extract the requested information. The document does not describe:
- A table of acceptance criteria for AI performance or reported device AI performance.
- Sample sizes for AI test sets or data provenance for AI.
- Number/qualifications of experts for AI ground truth.
- Adjudication method for AI ground truth.
- MRMC studies or effect sizes of human reader improvement with AI.
- Standalone AI algorithm performance.
- Type of ground truth for AI (e.g., pathology, outcomes data).
- Sample size for AI training set.
- How AI training set ground truth was established.
Therefore, I must state that the provided text does not contain the information required to answer your query regarding AI/ML device acceptance criteria and study details.
§ 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).