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The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalcaneal and tibiotalar joints.

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-6AI-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

This document is a 510(k) Premarket Notification for the ARIX Ankle Distal Tibia System. It states that no clinical studies were considered necessary and performed. Therefore, a study demonstrating the device meets acceptance criteria, an MRMC comparative effectiveness study, or a standalone algorithm-only study were not conducted or reported in this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Since no clinical study was performed, there are no reported acceptance criteria or device performance measurements in terms of clinical outcomes or diagnostic accuracy. The testing performed focused on compliance with material and mechanical standards.

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

Not applicable, as no clinical test set was used. The testing was non-clinical bench testing of the physical device components.

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)

Not applicable, as no clinical test set or ground truth established by medical experts was used.

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

Not applicable, as no clinical test set requiring adjudication was used.

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 MRMC comparative effectiveness study was done. The device is a physical bone fixation system, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical bone fixation system.

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

Not applicable, as no clinical ground truth was established for this device, which is a physical implant. The "ground truth" for the non-clinical testing was compliance with established ASTM standards for material properties and mechanical performance.

8. The sample size for the training set

Not applicable, as no training set was used. The device is a physical bone fixation system, not a machine learning model.

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

Not applicable, as no training set or its ground truth was established.

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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 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 plates are Medial Type and Anterolateral Type and T Type. The screws are Cortical Screw (28-SO-L Series, 35-SO-L Series) and Locking Screw (28L-SO-L Series, 35L-SO-L Series). The system is made of ASTM F 136, Titanium Alloy (Ti-6Al-4V). The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping, which are applied with the reconstruction locking screws together. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 80 mm. The system is provided as Gold color which is casted according to the anodizing technique while apply 5 V electric energy to the titanium. It also includes various manual surgical instruments, such as drill bits, counter sink, depth gauge, compression, drill guide, drill sleeve, guide pin, bender and screw driver handle. The ARIX Ankle Distal Tibia System is not provided sterile.

This document, K170313, describes the ARIX Ankle Distal Tibia System, a bone plate and screw system intended for fixation of intra- and extra-articular fractures and osteotomies of the distal tibia.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Bending strength test per ASTM F382-14
• Bending fatigue test per ASTM F382-14 | The test results for bending strength and bending fatigue for the ARIX Ankle Distal Tibia System indicate equivalence to the predicate device. (Page 6) |
  | Screws:
• Driving torque test per ASTM F543-13
• Torsion test per ASTM F543-13
• Axial pull out test per ASTM F543-13 | The test results for driving torque, torsion, and axial pull out for the ARIX Ankle Distal Tibia System indicate equivalence to the predicate device. (Page 6) |
  | Biocompatibility: Meet ASTM F136 for Titanium Alloy (Ti-6Al-4V) | Device material (ASTM F 136, Titanium Alloy) is widely used for surgical implants with well-known biocompatibility. (Page 5) |
  | Sterilization: Achieve a SAL of 10^-6 via autoclave, validated per ISO 17665-1: 2006 | Sterilization method validated per ISO 17665-1: 2006. (Page 5) |

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for specific tests. The document refers to "bench tests" performed using the "proposed device" and "predicate device." It doesn't specify the number of plates or screws tested for each mechanical test.
• Data Provenance: The study is a non-clinical bench test conducted to verify design specifications and compliance with ASTM standards. The provenance is internal testing performed by the manufacturer or a contracted lab. There is no mention of country of origin for the data itself, but the manufacturer is Jeil Medical Corporation in Korea. This is a retrospective analysis in the sense that the testing was performed to support the 510(k) submission, not as a prospective clinical trial.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This submission is for a medical device (bone fixation system) and relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device, not on diagnostic accuracy against a clinical ground truth established by experts.

4. Adjudication Method

• Not Applicable. As no expert review or clinical diagnosis is involved in the acceptance criteria, there is no adjudication method.

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

• No. The document explicitly states: "No clinical studies were considered necessary and performed." This means no MRMC study was conducted.

6. Standalone Performance Study

• Yes, a form of standalone performance was done for the device itself. The bench tests (bending strength, fatigue, driving torque, torsion, axial pull-out) assess the mechanical performance of the ARIX Ankle Distal Tibia System independently, comparing it to established standards and a predicate device. This is "standalone" in the sense that the mechanical behavior of the device components is evaluated without human interaction during the test, beyond setting up the experiment.

7. Type of Ground Truth Used

• Standardized Mechanical Performance Metrics / Predicate Device Performance. The "ground truth" for the acceptance criteria and performance evaluation is based on:
  • Compliance with recognized international standards (ASTM F382-14 for plates, ASTM F543-13 for screws).
  • Demonstration of equivalent mechanical performance to a legally marketed predicate device (Synthes LCP Distal Tibia Plates - K013248).

8. Sample Size for Training Set

• Not Applicable. This is a medical device (bone fixation system) and not an AI/ML diagnostic algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing process are informed by established engineering principles and material science, not by training on a dataset.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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