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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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