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The Avitus® DragonWing Large Volume Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.

The Avitus® Dragonwing™ Large Volume Autograft Delivery System is designed to deliver bone autograft or hydrated allograft material to an orthopaedic surgical site. The device delivers approximately up to 5cc of bone graft material per each reloadable five-channel cartridge. Each system comes with the following:

• · 2 x Graft Cartridge Features 5 graft channels, a latching lid, and connection points to the Delivery Cannula.
• · 1 x Bone Scoop Accessory Used to add graft to the Graft Cartridge channels.
• · 1 x Pack Tool Accessory Used to compress graft into the Graft Cartridge channels.
• · 1 x Delivery Cannula Features a handle frame which connects to a loaded Graft Cartridge and a straight-tipped cannula through which graft material is delivered to the orthopaedic surgical site.
• · 1 x Delivery Plunger Features a plunger rod and handle. During graft delivery, the Delivery Plunger is pushed through a Graft Cartridge channel to deploy graft material to the orthopaedic surgical site.

The provided text describes a 510(k) premarket notification for a medical device called the "Avitus® DragonWing Large Volume Autograft Delivery System." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based medical device.

The document discusses:

• The device's name, regulation number, and product code.
• The intended use of the device (delivery of autograft or hydrated allograft bone graft material).
• A comparison to a predicate device (Spinal Surgical Strategies, LLC Bi-Portal Bone Graft Delivery Device cleared under K142661).
• Technological characteristics like materials, mechanism of operation, recommended graft volume, bone graft exit hole configuration, and sterilization method.
• Non-clinical testing performed: device performance testing (using cadaveric bone graft material), sterilization validation, package integrity testing, shelf-life testing, and biocompatibility testing.
• A explicit statement that no clinical testing was performed for this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets the acceptance criteria for an AI/ML device, as this document pertains to a physical medical device (syringe/delivery system) and does not involve AI or ML.

If you have a document describing an AI/ML medical device, please provide that text, and I will be happy to extract the relevant information.

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The Avitus® Precision Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.

The Avitus Precision Autograft Delivery System is designed to deliver bone autograft or hydrated allograft material to an orthopaedic surgical site. The device delivers approximately up to 0.5cc of bone graft material per reloadable cartridge. Each system comes with the following:

• · 2 x Graft Cartridge Features a graft channel, latching lid, and connection points to the Delivery Cannula and Threaded Delivery Plunger.
• · 1 x Bone Loading Scoop Accessory Used to add graft to the Graft Cartridge channel.
• · 1 x Bone Packer Accessory Used to compress graft into the Graft Cartridge channel.
• · 1 x Straight Delivery Cannula Features a hub, which connects to a loaded Graft Cartridge, and straight-tipped cannula, through which graft material is delivered to the orthopaedic surgical site.
• · 1 x Angled Delivery Cannula Features a hub, which connects a loaded Graft Cartridge, and angle-tipped cannula, through which graft material is delivered laterally to the orthopaedic surgical site.
• · 1 x Threaded Delivery Plunger Features a plunger rod, knob, and threads. During graft delivery, the rod is depressed into the Graft Cartridge until the Plunger's threads engage with the Cartridge. This action transfers graft material into the Cannula. With the threads engaged, the user twists the Plunger knob to deliver a controlled volume of graft to the orthopaedic surgical site.

The provided text describes the Avitus Precision Autograft Delivery System, a medical device designed to deliver bone graft material. It includes a 510(k) summary for the device, comparing it to a predicate device and outlining non-clinical testing and biocompatibility assessments.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the Avitus Precision Autograft Delivery System. However, it states the overall conclusion from non-clinical testing:

2. Sample Size Used for the Test Set and Data Provenance

The text mentions "worst-case non-clinical testing" and the use of "cadaveric bone graft material." However, it does not specify the sample size used for this test set nor the specific provenance of the cadaveric bone graft material (e.g., country of origin). The testing described is retrospective in nature, as it's a verification of the device's performance post-design before market release.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the non-clinical performance testing. The "ground truth" for the device's performance appears to be established through engineering specifications and the observed functionality during testing with cadaveric material.

4. Adjudication Method for the Test Set

Since the document does not mention the use of experts or a formal ground truth establishment process involving multiple parties, there is no adjudication method described for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described is a delivery system for bone graft material, not an imaging or diagnostic device that would typically involve human readers. The text confirms: "No clinical testing was performed in association with this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Avitus Precision Autograft Delivery System is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply to this device. The non-clinical testing described focused on the physical device's performance.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was based on engineering specifications and observed physical performance of the device successfully delivering cadaveric bone graft material, and maintaining structural integrity. For biocompatibility, the ground truth was established by demonstrating material equivalence and identical processes to a previously cleared device (Avitus Bone Harvester) that had undergone standard biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity).

8. The Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning or AI algorithms. Since this is a physical medical device, there is no training set in that context. The development and design of the device would have involved iterative testing and refinement, but not a formal "training set" as understood in AI studies.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/algorithm, this question is not applicable. The "ground truth" for the device's design and functionality would have been established through engineering design principles, materials science, and physical prototyping, followed by verification and validation testing.

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