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The ARIX Cannulated Screw System is indicated for fracture fixation, fusions, osteotomies, and malunions of fragments of long bones of the pelvis, the femur, the humerus, and the foot. The system is not intended for use in the spine.

The ARIX Cannulated Screw System consists of cannulated screws and corresponding washer. The thread diameters of cannulated screws are 6.5 and 7.3 mm. They are either fully or partially threaded. Screws and a washer are made of Titanium Alloy (Ti-6Al-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. All devices in the system are provided non-sterile.

The provided document, K233912, is a 510(k) Premarket Notification for the ARIX Cannulated Screw System. This document outlines the premarket review by the FDA for a medical device, specifically a bone fixation fastener, and not an AI/ML-driven diagnostic or prognostic device.

Therefore, the information typically requested in your prompt regarding AI/ML device studies (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance, etc.) is not applicable to this submission.

The document discusses bench tests for mechanical performance to demonstrate substantial equivalence to a predicate device. Here's what can be extracted from the document regarding its performance criteria and testing:

1. Acceptance Criteria and Reported Device Performance (Mechanical Testing):

• Torsion Test
• Driving Torque Test
• Axial Pull-out Test |

2. Sample Size and Data Provenance:

• Sample Size: The document does not specify the sample size (number of screws) used for the mechanical bench tests.
• Data Provenance: Not applicable in terms of patient data. The tests were bench tests conducted on the physical device. The manufacturer is Jeil Medical Corporation in South Korea.

3. Number of Experts and Qualifications (for Ground Truth):

• Not applicable. Ground truth for mechanical performance is established through standardized engineering test methods (ASTM F543) and physical measurements, not human expert consensus.

4. Adjudication Method:

• Not applicable for mechanical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is a physical medical device, not an AI/ML system requiring human reader performance evaluation. The document explicitly states: "No clinical studies were considered necessary and performed."

6. Standalone Performance:

• Not applicable. This refers to the performance of the physical device in bench tests, not an AI algorithm. The document states its performance was evaluated for each mechanical test according to ASTM F543.

7. Type of Ground Truth Used:

• Engineering Standards and Physical Measurements: For mechanical performance, the ground truth is based on the specifications and test methods outlined in ASTM F543. Measurements from the tests (e.g., torque, axial pull-out force) are compared against these established physical and material science standards.

8. Sample Size for Training Set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable.

In summary, the provided document relates to the FDA clearance of a conventional medical device based on mechanical bench testing and substantial equivalence to a predicate device, rather than the evaluation of an AI-powered diagnostic or prognostic tool. Therefore, many of the requested details about AI/ML study methodologies are not present in this type of FDA submission.

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The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The Hammerdesis™ Interphalangeal Fusion system is composed of a counter rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg and hole fusion of the phalanges. The implant comes in two different sizes to accommodate differing anatomies. The counter rotation ring has axial spikes that prevent either side of the joint from rotating and allow fusion of the joint.

The provided text is a 510(k) summary for the Hammerdesis™ Interphalangeal Fusion System, a medical device. This document focuses on demonstrating the substantial equivalence of the device to existing predicate devices, primarily through mechanical performance testing.

It does not contain information about an AI/ML-driven device or diagnostic study. Therefore, I cannot provide a response addressing acceptance criteria and study details related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document describes the device, its indications for use, technological characteristics, and performance data related to its mechanical properties. The performance data section states:

"The subject Hammerdesis™ Interphalangeal Fusion System was evaluated in static torsion test, static and dynamic cantilever bend testing, and axial pullout. The subject device demonstrated superior performance in comparison to that of the predicate (K131459); therefore, the subject device mechanical performance is considered substantially equivalent to the predicate (K131459)."

This indicates that the acceptance criteria for this device are based on its mechanical equivalence or superiority to the specified predicate device in these specific tests, rather than diagnostic accuracy metrics.

To answer your request, the provided document would need to be about a diagnostic AI/ML device, which it is not.

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