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The ARIX Ankle Distal Tibia System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal tibia including distal tibia fractures in combination with diaphyseal fracture.

The ARIX Ankle Distal Tibia System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Ankle Distal Tibia System is 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. The plates vary essentially through different lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Screws are provided with diameter 3.5mm and 4.0mm. And Screws are provided with lengths from 10mm to 110mm.

The provided document is a 510(k) summary for the "ARIX Ankle Distal Tibia System," a device intended for bone fixation. However, it explicitly states, "No clinical studies were considered necessary and performed." Therefore, there is no information available within this document regarding acceptance criteria or a study proving the device meets those criteria, as no clinical study was conducted.

The document focuses on demonstrating substantial equivalence to a predicate device (K170313) through bench tests and technological characteristics comparison. The bench tests conducted verified the device met design specifications and complied with ASTM standards for metallic bone plates and screws.

Here's a breakdown of what can be extracted from the document, acknowledging the absence of clinical study data:

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

Since no clinical study was performed, there are no reported clinical performance criteria or results. The document mentions bench test results indicating compliance with ASTM standards, these would act as performance criteria for mechanical characteristics.

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

• Test Set Sample Size: Not specified for the bench tests.
• Data Provenance: The bench tests were conducted internally by the manufacturer ("Non-Clinical Test Summary"). The geographical origin is therefore Korea, South (location of Jeil Medical Corporation). The data is by definition prospective (designed and executed for this submission).

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

This information is not applicable as no clinical study was performed. The "ground truth" for the non-clinical bench tests is established by the ASTM standards and mechanical engineering principles.

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

This information is not applicable as no clinical study was performed. Adjudication methods are typically used in clinical trials to resolve discrepancies in expert evaluations.

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:

This information is not applicable as no clinical study was performed and this device is a physical bone fixation system, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable as this device is a physical bone fixation system, not an algorithm.

7. The type of ground truth used:

• For the bench tests, the "ground truth" is defined by the ASTM standards (ASTM F382, ASTM F543), which set the criteria for mechanical properties, and the performance of the predicate device (K170313), against which the subject device's performance was compared for equivalence.

8. The sample size for the training set:

This information is not applicable as no clinical study was performed. A "training set" typically refers to data used to train machine learning models or for initial clinical observations, neither of which are mentioned here.

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

This information is not applicable as no clinical study was performed and therefore no training set.

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The ARIX Elbow System is intended for fractures and osteotomies of proximal radius, ulnar olecranon and distal humerus. The ARIX Proximal Radius Plate is intended for use in proximal radial fractures and osteotomies. The ARIX Olecranon Plate is intended for use in particular for ulna fractures and osteotomies. The ARIX Distal Humerus Plate is intended for use in distal humerus fractures, osteotomies and non-unions.

The ARIX Elbow System is consist of proximal radius plate, ulna olecranon plate, distal humerus plate and bone screw. The ARIX Elbow System is made of Unalloyed Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and 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. The plates vary essentially through different type and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments such as drill bits, drill sleeve and sleeve handle, driver, depth gauge, bender, handle, driver shafts and depth gauge. The ARIX Elbow 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.

This looks like a 510(k) premarket notification for a medical device called the "ARIX Elbow System," which is a metallic bone fixation appliance. It is important to note that this document is for a physical medical device (bone plates and screws), not a software or AI-based diagnostic device. Therefore, the questions about acceptance criteria, study design for AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment, etc.), and training/test set sample sizes as typically applied to AI/ML devices do not directly apply in the context of this 510(k) summary.

However, I can extract information related to the device's performance justification based on the provided document, adapting your questions to fit the context of a physical orthopedic implant.

Here's an analysis based on the provided text, indicating where the requested information is not applicable for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" and "performance" are typically demonstrated through adherence to recognized national/international standards for mechanical properties and biocompatibility, and through comparison to predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not applicable in the traditional sense of a "test set" for an AI/ML algorithm. The "test" here refers to non-clinical (bench) testing of the physical device components. For non-clinical tests, the sample size would typically be a small number of representative devices tested according to the respective ASTM standards (e.g., typically N=5 to 10 for mechanical tests, per standard guidelines). The document does not specify the exact number of units tested for each non-clinical test.
• Data Provenance: Not applicable for a non-AI physical device. The "data" comes from controlled laboratory bench tests adhering to international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not Applicable. This is a physical orthopedic implant. There is no "ground truth" in the context of expert review for an AI/ML diagnostic output. Device performance is assessed via objective, quantifiable mechanical and material properties or sterilization efficacy, measured against established standards.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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 a physical device, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable in the AI/ML context. For this device, "ground truth" or verification is based on:
  • Objective Measurement against Bending/Torsional/Tensile Strength Standards: Mechanical properties (e.g., measured force, displacement, cycles to failure, pull-out strength, fatigue life) determined via bench testing per ASTM F543 and F382.
  • Material Composition/Purity Specifications: Verification that the materials meet ASTM F67 and F136.
  • Sterility Assurance Level (SAL): Verification that the sterilization process achieves a 10^-6 SAL per ISO 17665-1.
  • Comparison to Predicate Device: Demonstrating similar characteristics and performance to already cleared devices.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8.

Summary of Device Justification from the Document:

The ARIX Elbow System demonstrated its "acceptance criteria" and "performance" through:

• Material Compliance: Use of medical-grade titanium alloys (Ti-6AL-4V) meeting ASTM F67 and F136, indicating known biocompatibility.
• Non-Clinical Bench Testing: Demonstrated compliance with ASTM F543 (for screws) and ASTM F382 (for plates), ensuring the devices meet established mechanical performance standards for bone fixation. The results indicated equivalence to the predicate device.
• Sterilization Validation: Validation of the recommended autoclave sterilization method to achieve the required 10^-6 SAL per ISO 17665-1, ensuring the product can be safely prepared for surgery.
• Substantial Equivalence: A direct comparison to identified predicate devices (Medartis AG APTUS systems and Synthes Modular Mini Fragment LCP System) confirmed similarities in indications for use, technological characteristics, operating principle, design features, expected performance, biocompatibility, materials, and sterilization methods. No significant differences affecting safety or effectiveness were identified.
• No Clinical Studies: The submission explicitly states, "No clinical studies were considered necessary and performed," which is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.

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