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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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The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors).

The proposed device is a minimally invasive manual non-powered cancellous bone and marrow graft harvester that can also be used for the removal of infected, necrotic, and diseased cancellous bone. The proposed changes described in this submission add to the types of materials to be collected to include infected, necrotic, or diseased cancellous bone. The Avitus® Bone Harvester consists of a metal cutting tip and shaft with transparent plastic handle, filter, collection chamber, and a threaded plastic cap.

The principles of action for the proposed device with revised indications for use are identical to the predicate device. The Avitus® Bone Harvester is a manual surgical instrument that harvests cancellous bone and marrow, and debrides infected, necrotic, or diseased cancellous bone by manual actuation of the cutting tip. The Cap contains a barbed nozzle that connects to standard sized suction tubing to connect to a vacuum source. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes, cuts, and collects the material into the reservoir filter insert inside the Handle. The Cap has a filter feature that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle.

This document is a 510(k) premarket notification for a medical device called the Avitus® Bone Harvester. It's an application to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a clinical trial report proving efficacy or safety from scratch.

Therefore, the information you're asking for, which is typical for studies proving device performance against acceptance criteria for AI/ML-based devices or complex diagnostic tools, is not present in this document.

Here's why and what's missing:

• This is not a software/AI device: The Avitus® Bone Harvester is a manual surgical instrument. It harvests bone and marrow and debrides diseased bone. There's no mention of AI, algorithms, or any software component.
• This is not a diagnostic device: It's a surgical tool for material collection and debridement, not for diagnosing conditions or generating images that require expert interpretation.
• Nature of the submission: This K210631 submission is primarily about expanding the Indications for Use of an already cleared device (K170539). The core argument for substantial equivalence relies on the fact that the device's technological characteristics (design, materials, operating principles) have not changed. The modifications are only to the intended use.
• "Non-Clinical Testing" and "Clinical Testing" sections explicitly state:
  • "Non-clinical testing was not conducted in association with this submission." (Section 5.10)
  • "No clinical studies were conducted in association with this submission." (Section 5.12)
  • Biocompatibility was conducted in prior submissions because no new materials were introduced.

To directly answer your questions based on the provided text, the answer to almost all of them is "Not applicable" or "No information provided," as this kind of study was not performed for this submission.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Not applicable / No information provided. This document does not describe performance acceptance criteria or results from a study designed to meet them. The core of this submission is a comparison of technological characteristics and indications for use to a predicate device, as shown in Table 5.1. The "performance" being evaluated is whether the device, with its unchanged design, can perform the expanded intended use (debriding diseased bone) safely and effectively, which is inferred to be true because its mechanism is identical to its previous, cleared indication for harvesting healthy bone.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not applicable / No test set used. No new testing (clinical or non-clinical) was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No test set or ground truth establishment was conducted for this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No test set or expert adjudication was conducted for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not an AI-assisted device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. No new ground truth was established as no new studies were conducted. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (K170539) and the argument that the identical technological characteristics allow for the expanded indications.

8. The sample size for the training set:

   • Not applicable. This device does not use a training set.

9. How the ground truth for the training set was established:

   • Not applicable. This device does not use a training set.

In summary, this document is a regulatory filing for a physical medical device (bone harvester) and specifically states that no new non-clinical or clinical testing was conducted for this submission, as it relies on substantial equivalence to a previously cleared predicate device for an expanded indication.

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The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow.

The proposed device is a manual surgical instrument that cuts cancellous bone by manual actuation of the cutting tip. The Cap contains a barbed nozzle that connects to standard sized suction tubing connect to a vacuum source. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bone reservoir inside the handle. The Cap has a filter feature that prevents material from escaping the handle into the suction system by utilizing a physical sieve. After harvesting, the bone graft can be retrieved from the handle. The proposed device includes a Filter Insert accessory that can assist the user to scoop the bone out from within the Handle after harvesting.

This document is a 510(k) Pre-Market Notification from the FDA regarding the Avitus® Bone Harvester with Filter Insert - 5mm. It is a clearance letter and a summary, not a detailed study report. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving device performance is not present in this document.

However, based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance. It only mentions that "These tests concluded that the proposed device will perform in a manner that exceeds anticipated clinical loads and are therefore, substantially equivalent to the predicate Avitus® Bone Harvester - 8mm device (K152474)." This implies the acceptance criterion was "demonstrating performance that exceeds anticipated clinical loads" and "substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the non-clinical tests (Clinical Load Evaluation, Worst Case Failure of Cutting Tip Breakage, Benchtop Verification Test). It does not provide information on data provenance (country of origin, retrospective/prospective) for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided text. The non-clinical tests described are benchtop tests, not human interpretation studies, so "ground truth" in the context of expert consensus is not applicable here.

4. Adjudication method for the test set

This information is not available in the provided text. The tests performed are engineering/benchtop evaluations, not studies requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was performed or mentioned. The device is a manual surgical instrument, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a manual surgical instrument.

7. The type of ground truth used

For the non-clinical tests mentioned, the "ground truth" would be established by engineering specifications, material properties, and mechanical testing standards. For example, the "Clinical Load Evaluation" would likely involve testing under defined load conditions to see if the device meets or exceeds specified strength or durability requirements.

8. The sample size for the training set

This is not applicable as the device is a manual surgical instrument and not an AI/algorithm-based system requiring a training set.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above.

Summary of the Study Mentioned:

The document refers to "Non-Clinical Testing" which included:

• Clinical Load Evaluation: Tested the device's ability to withstand anticipated loads.
• Worst Case Failure of Cutting Tip Breakage: Evaluated the device's resilience under extreme conditions.
• Benchtop Verification Test: General verification tests performed in a laboratory setting.

These tests were performed to demonstrate that the proposed device, the Avitus® Bone Harvester with Filter Insert - 5mm, is substantially equivalent to the predicate device (Avitus® Bone Harvester - 8mm, K152474) and performs in a manner that exceeds anticipated clinical loads. No clinical testing, multi-reader studies, or AI-specific evaluations were performed. The materials used in the proposed device were confirmed to be biocompatible, being identical to the materials in the predicate device.

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The Avitus(TM) Bone Harvester is intended to harvest cancellous bone and marrow.

The proposed device is a manual surgical instrument that cuts cancellous bone by manual actuation of the cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an ID of 6-10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is an FDA 510(k) premarket notification letter for the Avitus™ Bone Harvester, detailing its substantial equivalence to a predicate device and its intended use. It mentions non-clinical testing for load evaluation and tip breakage, and biocompatibility testing, but it does not provide specific acceptance criteria values or detailed study results with the requested parameters.

Therefore, I cannot fulfill your request for the table of acceptance criteria, detailed study information, sample sizes, ground truth establishment, or multi-reader multi-case study results.

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