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The ARIX Hand Locking System is intended for use in 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 Hand Locking System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Hand Locking 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 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The plates vary essentially through different lengths and number of plate holes. The cortical screws & locking screws diameter is 2.0mm and lengths is from 6mm to 30mm. It also includes various manual surgical instruments, as drill quides, drill bits, driver shafts, depth gauge, bender and handbody. The ARIX Hand Locking System is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the hospital prior to surgery.

Here's a breakdown of the acceptance criteria and study information for the ARIX Hand Locking System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a 'test set' in the context of clinical data for the device. The testing described is bench testing only. Therefore, the sample sizes refer to the number of plates and screws tested in vitro according to the specified ASTM standards. The exact number of samples for each specific test (e.g., number of plates for tensile strength, number of screws for driving torque) is not provided in the document.

• Test Set Sample Size: Not explicitly stated for specific tests; implied to be sufficient for compliance with ASTM standards.
• Data Provenance: Not applicable as no clinical human data was used. The data comes from in vitro bench testing conducted presumably by Jeil Medical Corporation or a contracted lab.

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

Not applicable. No ground truth was established by human experts for a test set, as no clinical studies were performed. The "ground truth" for compliance was defined by the ASTM standards and design specifications.

4. Adjudication Method for the Test Set

Not applicable. No human adjudication was involved as no clinical studies were performed. The compliance was determined by objective measurements against established engineering standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "No clinical studies were considered necessary and performed."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical bone fixation system, not a software algorithm or AI-driven tool. Therefore, a "standalone algorithm performance" study is not relevant.

7. Type of Ground Truth Used

The ground truth used was objective engineering standards (ASTM F 382-99 and ASTM F 543-07) and the manufacturer's own design specifications for the physical properties and performance of the plates and screws.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI or algorithm-driven system that requires training data.

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

Not applicable, as there was no training set.

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