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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:

1. A table of acceptance criteria for AI performance or reported device AI performance.
2. Sample sizes for AI test sets or data provenance for AI.
3. Number/qualifications of experts for AI ground truth.
4. Adjudication method for AI ground truth.
5. MRMC studies or effect sizes of human reader improvement with AI.
6. Standalone AI algorithm performance.
7. Type of ground truth for AI (e.g., pathology, outcomes data).
8. Sample size for AI training set.
9. 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.

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