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The ARIX Ankle System is intended for use in internal fixation of the distal fibula.

The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes. The ARIX Ankle 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 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

This document describes a 510(k) premarket notification for the "ARIX Ankle System," which is a device for internal fixation of the distal fibula. The submission claims substantial equivalence to existing predicate devices.

Crucially, the provided text explicitly states there was no clinical study performed for this device, and therefore no data regarding AI performance, acceptance criteria for AI, or human reader studies.

Therefore, I cannot provide the requested information about acceptance criteria for AI, study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.

The relevant section from the document states:

"Clinical Test Summary
No clinical studies were considered necessary and performed."

This indicates that the FDA clearance for the ARIX Ankle System was based on non-clinical bench testing and a comparison of its technological characteristics and intended use to predicate devices, not on a study involving AI performance or human reader analysis.

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The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.

The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Ankle 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 lengths and number of plate holes. The screws are self-tapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 3.5mm and Cortical Screws are provided with diameter 3.5mm. And both are provided with lengths from 10 mm to 70 mm.

The provided text describes the 510(k) premarket notification for the ARIX Ankle System, a bone fixation device. It details the device's characteristics, intended use, and comparison to a predicate device. However, this document does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria related to diagnostic performance or efficacy.

The FDA letter and the 510(k) summary are for a mechanical orthopedic implant (plates and screws for ankle fixation), not an AI-powered diagnostic device. Therefore, the questions about AI performance, ground truth, expert readers, MRMC studies, and training/test set sizes are not applicable to this submission.

The "Non-Clinical Test Summary" section mentions engineering analyses and ASTM standards (F382 for bending performance, F543 for screw testing), which are mechanical performance tests for the implant, not diagnostic accuracy. The "Clinical Test Summary" explicitly states: "No clinical studies were considered necessary and performed." This further confirms the absence of performance data relevant to AI acceptance criteria.

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The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.

The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Ankle 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 are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The cortical screws, locking screws diameter is 3.5mm lengths is from 10mm to 70mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc., The ARIX Ankle 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 describes a 510(k) premarket notification for the ARIX Ankle System, a device for internal fixation of the distal fibula. The submission aims to demonstrate substantial equivalence to a predicate device, the VariAX™ Distal Fibula Plate (K081284).

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

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

The document doesn't explicitly define "acceptance criteria" with specific numerical targets in the same way a clinical trial might for a diagnostic device. Instead, the performance is reported against established ASTM standards for metallic bone plates and screws. The "acceptance criteria" are implied to be conformance with these standards and equivalency to the predicate device.

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

• Sample size: The document does not specify the sample size used for the bench tests. It mentions "plates" and "screws" in general, implying a set of each type was tested, but no numbers are provided.
• Data provenance: The data provenance is from non-clinical bench testing conducted to verify that the proposed device met design specifications and complied with ASTM standards. There is no information regarding country of origin for the test data, nor is it retrospective or prospective in the clinical sense, as no human data was involved.

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 the study was non-clinical bench testing. Ground truth in this context would be defined by the specifications of the ASTM standards and the design specifications of the device, not expert consensus.

4. Adjudication method for the test set:

This information is not applicable as the study was non-clinical bench testing. Performance was assessed against objective engineering standards and specifications.

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. The device is a physical bone fixation system, not an AI or imaging diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant.

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

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

7. The type of ground truth used:

The ground truth used for the non-clinical tests was based on:

• ASTM Standards: Specifically, ASTM F 382-99 for metallic bone plates and ASTM F 543-07 for metallic medical bone screws.
• Design Specifications: The device was tested to verify it met its "design specifications."
• Predicate Device Characteristics: The performance and characteristics were compared to the predicate device to establish substantial equivalence.

8. The sample size for the training set:

This information is not applicable. There was no "training set" in the context of an AI/machine learning model, as this is a physical medical device.

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

This information is not applicable. There was no training set or ground truth in the AI/machine learning sense.

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