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The ARIX Foot System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

The ARIX Foot System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Foot System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67 and ASTM F136. The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with various diameters. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 50 mm, lag screws (Cannulated and Cannulated Headless Types) with diameters of 1.5 mm to 6.0 mm and lengths of 8 mm to 80 mm. It also includes various manual surgical instruments, such as guide pins, drill guides, drill bits and driver shafts, washers, drill sleeve, depth gauge, bender, cleaning stylet and handbody. The ARIX Foot System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery.

The provided 510(k) summary describes the ARIX Foot System, a medical device for bone fixation. However, it does not contain the kind of detailed information about acceptance criteria, study design, and performance metrics as typically expected for evaluating AI/algorithm-based devices with standalone performance or human-in-the-loop improvements. This summary pertains to a traditional medical implant, and the assessment is based on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and study presented.

Here's a breakdown of the available information based on the prompt's requirements:

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

2. Sample sized 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 the document. For bench testing, "sample size" would refer to the number of plates and screws tested per standard. Data provenance is not applicable as this involves non-clinical bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this device relies on objective engineering standards (ASTM) for performance, not expert-derived ground truth from patient data.

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

This information is not applicable as this device relies on objective engineering standards (ASTM) for performance, not expert-derived ground truth from patient data requiring adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone fixation system, not an AI or imaging diagnostic tool that would typically involve human readers.

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

No, this information is not applicable. This is a physical medical implant, not a software algorithm.

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

For the non-clinical tests, the "ground truth" or reference standard used was the specifications and test methods defined by ASTM F 382-99 (for plates) and ASTM F 543-07 (for screws).

8. The sample size for the training set

This information is not applicable. This device is a physical product, not a machine learning model that requires a "training set."

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

This information is not applicable for the reasons stated above.

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