Search Results

ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

ARIX Femur Nail System (Nail, Lag Screw, Interlocking Screw, Set Screw, and End Cap) is made of Titanium Alloy which meets ASTM F136. ARIX Femur Nail System is provided Sterile or Non-Sterile.

The provided text is an FDA 510(k) Clearance Letter for the ARIX Femur Nail System. This type of document is for a physical medical device (an intramedullary fixation rod), not a software or AI-powered device. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and AI-specific metrics (like human improvement with AI assistance) are not applicable to the information given in this document.

For medical devices like the ARIX Femur Nail System, "acceptance criteria" are generally tied to meeting established industry standards for performance, material properties, and biocompatibility, rather than diagnostic accuracy or algorithmic performance. The "study that proves the device meets the acceptance criteria" refers to bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

Here's a breakdown of the information that is available based on your request, with an explanation of why other points are not applicable:

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

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

This information is not provided in a 510(k) summary for bench testing. The "test set" in this context refers to the physical samples of the device components manufactured for the specified mechanical and material tests. The document does not specify the number of samples tested for each benchmark. There is no patient data involved, as no clinical studies were performed.

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

Not applicable. "Ground truth" in this context would refer to the established pass/fail criteria for mechanical and material tests, which are defined by the ASTM standards themselves. These are engineering specifications, not expert interpretations of clinical data.

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

Not applicable. This refers to methods for reconciling discordant expert opinions in clinical studies, which were not conducted.

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:

Not applicable. This is not an AI-powered device, and no MRMC studies or clinical studies were performed.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" for the device's performance is established by the specified ASTM (American Society for Testing and Materials) standards. These are internationally recognized engineering standards that define the methods and criteria for evaluating the mechanical properties and performance of medical implants.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve machine learning or a training set.

Ask a specific question about this device