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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 ARIX Cannulated Screw System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid-and hind foot and ankle. Also, the ARIX Cannulated Screw System is internal fixation of the bones of hand and wrist. 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 Cannulated Screw System consists of cannulated screw with diameters raging from 2.3mm to 6.0mm. The cannulate screws are made of Titanium Alloy(Ti-6AI-4V), ASTM F136, which are widely used for surgical implants with well-known biocompatibility and provided nonsterile. This submission is to reclassify the previously approved device and to add 4.0mm diameter screws.

It also includes washer various manual surgical instruments, such as drill bit, screwdriver shaft, countersink, screwdriver handle, depth gauge, guide pin, cleaning stylet, dispenser, forceps and drill guide.

The ARIX Cannulated Screw System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided text is a 510(k) summary for the ARIX Cannulated Screw System, which is a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and proving performance through a study with the detailed elements you've requested.

Therefore, much of the information you've asked for, particularly regarding acceptance criteria, specific performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, is not available in this document.

However, I can extract the relevant information from the document:

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

The document doesn't define specific "acceptance criteria" in terms of performance thresholds for the device itself against clinical outcomes or diagnostic accuracy. Instead, it relies on demonstrating compliance with recognized standards and equivalence to predicate devices. The "reported device performance" is primarily the successful passing of these non-clinical tests.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. The document describes non-clinical laboratory testing of bone screws, not a study involving a test set of data or patient samples.
• Data Provenance: Not applicable. The testing was non-clinical and conducted in a laboratory setting. There is no mention of country of origin for data or whether it was retrospective or prospective.

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

• Number of Experts: Not applicable. There was no "ground truth" to establish in the context of diagnostic accuracy or clinical outcomes for this device.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. There was no test set requiring expert 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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a bone screw, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. This device is a physical medical implant, not an algorithm.

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

• Type of Ground Truth: Not applicable. The "ground truth" for this device involved engineering specifications and biomechanical performance standards (ASTM F543).

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is not an AI algorithm requiring a training set.

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

• How Ground Truth for Training Set was Established: Not applicable.

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