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The Arthrex Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 year) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

The proposed Arthrex Mini Fragment System consists of a series of plates and screws of varying lengths and thicknesses. Each plate provides locking screw fixation. The proposed screws are a family of locking and non-locking screws. The proposed plates and screws are manufactured from Titanium Alloy. The proposed plates and screws are sold non-sterile and single-use.

The provided text describes a 510(k) premarket notification for the Arthrex Mini Fragment System. This document focuses on the mechanical and material performance of the device compared to a predicate device, rather than the performance of an AI/ML-driven diagnostic or image analysis device. Therefore, many of the requested criteria related to AI/ML device performance (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this submission.

The acceptance criteria and study proving the device meets them are based on bench testing (mechanical and MRI compatibility), demonstrating substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the available information relevant to your request, with an emphasis on why certain sections are not applicable in this context:

Acceptance Criteria and Device Performance (for a Mechanical Fixation System)

The "acceptance criteria" for the Arthrex Mini Fragment System are demonstrated by showing that its mechanical performance is statistically equivalent to the predicate device, and that it meets established MRI safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable or Not Provided for a Mechanical Device:

2. Sample size used for the test set and the data provenance: Not applicable. This refers to the number of physical test specimens used for bench testing, not a "test set" of patient data for AI/ML. The document does not specify the number of samples tested for each mechanical or MRI test, nor data provenance (as it's bench data, not clinical data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is established by engineering specifications, material science, and physical testing standards.
4. Adjudication method for the test set: Not applicable. There is no human interpretation of a test set in this context.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, not for mechanical implants.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used: For mechanical performance, the "ground truth" is defined by the established ASTM standards and the performance of the predicate device. For MRI compatibility, it is defined by the specific ASTM standards and FDA guidance. This is not "expert consensus, pathology, or outcomes data" in the typical sense of medical diagnostics.
8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established: Not applicable. Since there's no training set, there's no ground truth to establish for it.

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