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The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.

The ARIX Wrist System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Wrist System is made of Unalloyed Titanium Alloy (Ti-6AI-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 lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 1.5mm and 2.5mm. The Non-locking Screws are provided with diameter 2.5mm. The Smooth Peg Screws are provided with diameter 2.0mm. And Locking Screws are provided with lengths from 4mm to 56mm. Non-locking Screws are provided with lengths from 6mm to 56mm and Smooth Peg Screws are provided with lengths from 10mm to 30mm.

The provided text is a 510(k) summary for the ARIX Wrist System, a medical device for bone fixation. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on non-clinical (bench) testing.

However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device. The ARIX Wrist System is a physical metallic bone fixation appliance, and its clearance relies on demonstrating substantial equivalence to similar predicate devices through bench testing of mechanical properties and biocompatibility, not through clinical or standalone performance studies of an AI algorithm.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance: This document does not describe performance metrics or acceptance criteria for an AI/ML device. It focuses on the physical properties and mechanical performance of a metallic implant.
2. Sample size for the test set and data provenance: No test set of clinical images or data is mentioned for an AI/ML study. The "test set" refers to the physical devices undergoing bench tests (e.g., plates and screws).
3. Number of experts and qualifications for ground truth: No expert annotation or ground truth establishment relevant to AI/ML is mentioned.
4. Adjudication method: Not applicable to a physical implant.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device.
6. Standalone performance (algorithm only): Not applicable, as there is no algorithm.
7. Type of ground truth used: Not applicable in the context of AI/ML ground truth. The "ground truth" for this device would be its physical and mechanical properties, assessed through standardized bench tests.
8. Sample size for the training set: Not applicable, as there is no AI model requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The document states:

• "Bench tests were conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with the following standards: ASTM F382, Standard Specification and Test Method for Metallic Bone Plates; ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws."
• "The following tests were performed with the predicate device: Plate (4-Point Bending Test, 4-Point Fatigue Test), Screw (Driving Torque Test, Torsion Test, Axial Pull-out Test), Smooth Peg Screw (3-Point Bending Test)."
• "The results of this testing indicate that the ARIX Wrist System is equivalent to predicate device."
• "No clinical studies were considered necessary and performed."

This clearly indicates that the clearance was based on non-clinical bench testing comparing the physical device's mechanical performance to established standards and predicate devices, not on a study involving AI/ML and human clinical data.

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The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.

The ARIX Wrist System consists of plates designed for the Ulna and Radius. The ARIX Wrist System is made of Pure Titanium and 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-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 vary essentially through different lengths and diameters. The screws in this system are available from 2.0mm to 2.8mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and hand body. The ARIX Wrist System not provided sterile. It is required to be sterilized via autoclave using the validated method prior to surgery.

The provided text is a 510(k) Summary for the ARIX Wrist System. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, the information required for the requested table and study details (acceptance criteria, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not present in the provided text.

The text describes bench tests conducted, but these are for mechanical properties of the device components (plates and screws) against ASTM standards, not for evaluating an algorithmic performance.

Here's a breakdown of what is available from the text, and what is missing:

What is present (related to traditional device testing):

• Bench Tests: The document lists several bench tests performed on the plates and screws, primarily against ASTM standards (ASTM F 382 for plates, ASTM F 543 for screws). These tests assess mechanical properties like dimensions, bending, fatigue, driving torque, axial pull-out, and torsion.
• Conclusion on Equivalence: The document concludes that the ARIX Wrist System is substantially equivalent to predicate devices based on these bench tests and shared characteristics.
• No Clinical Studies: The document explicitly states: "No clinical studies were considered necessary and performed." This means there would be no human reader studies or direct human performance data in this submission.

What is missing (which would be relevant for an AI/algorithm device study):

1. Table of Acceptance Criteria and Reported Device Performance (for an algorithm): No such table is provided, as this is not an algorithm's performance being evaluated. The bench tests indicate compliance with mechanical standards, but not a specific performance metric like sensitivity or specificity.
2. Sample sizes used for the test set and data provenance: Not applicable, as there is no "test set" of data for algorithmic evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No such study was done or reported.
6. If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In essence, the provided document is a regulatory submission for a physical medical device (bone fixation system), not a software or AI-driven device requiring performance evaluation against diagnostic or predictive metrics. Therefore, the requested information pertaining to acceptance criteria and studies for an algorithm's performance is not contained within this text.

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The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.

The ARIX Wrist System is consists of the Radius & Ulna. It is rigid fixation plates and screws which were recommended combination as follow;
Type / Configuration: Radius, Ulna
Plate: 25-DVRA Series, 25-DLUL Series
Screw: Self-tapping Cortical Screw (25-HF Series), Self-tapping Locking Screw (161.0325 Series for Radius, 25L-HF Series for Ulna)
Material: ASTM F 67 Pure Titanium (Plate), ASTM F 136 Titanium Alloy (Ti-6Al-4V) (Screws)
The ARIX Wrist System is made of Pure Titanium and 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 h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The self-tapping cortical screws & self-tapping locking screws diameter is 2.5mm and lengths is from 8mm to 38mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc,. The ARIX Wrist 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.

This document is a 510(k) premarket notification for the "ARIX Wrist System" and does not contain information about an AI/ML powered device. Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details, and AI/ML specific aspects from this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a medical implant (bone plates and screws) through material composition, design features, and non-clinical bench testing.

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