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The ARIX Hand System is intended for use in internal fixation of thand 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 System is designed to 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 System consists of the ARIX Hand System Plate and the ARIX Hand System Screw. The ARIX Hand System Plate is made of Pure Titanium (ASTM F67) and the ARIX Hand System Screw is made of the Titanium Alloy (ASTM F136). This device performance is not adversely affected by aging or storage conditions since this device is to be sterilized at the hospital before use and also to be single use.

The document describes a 510(k) premarket notification for the ARIX Hand System, a bone plate and screw system. The submission aims to demonstrate substantial equivalence to a predicate device (K131566) also named ARIX Hand System. The information provided is primarily focused on the non-clinical testing performed to establish this equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific numerical thresholds that the device must meet for each test. Instead, it states that the tests were performed to "verify that the proposed device met all design specifications" and that the results "indicate that the ARIX Hand System is equivalent to predicate device." Therefore, the implied acceptance criterion is that the device's performance in these non-clinical tests is comparable or superior to the predicate device.

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

• Sample Size: The document does not specify the exact number of plates or screws tested for each non-clinical test.
• Data Provenance: The tests are "Bench tests," which implies they were conducted in a laboratory setting. The country of origin of the data is not explicitly stated, but the submitter (Jeil Medical Corporation) is based in Korea. The studies are retrospective in the sense that they are laboratory tests on manufactured devices, not prospective clinical trials.

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

This section is not applicable as the study is a non-clinical bench testing study, not a clinical study involving diagnosis or interpretation by experts. Ground truth is established by the physical testing results against standard specifications.

4. Adjudication Method for the Test Set

This section is not applicable for a non-clinical bench testing study. Adjudication typically refers to expert review in clinical trials or diagnostic studies.

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

A MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were considered necessary and performed."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This section is not applicable. The device is a physical medical implant (bone plate and screw), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for these non-clinical mechanical tests is based on engineering standards and specifications (ASTM F382-99 for plates and ASTM F543-07 for screws). The performance of the subject device is compared against these standards and against the predicate device's performance.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning model.

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

This section is not applicable for the same reason as above.

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The ARIX Hand 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 System is designed to 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 System consists of the ARIX Hand System Plate and the ARIX Hand System Screw. The ARIX Hand System Plate is made of Pure Titanium (ASTM F67) and the ARIX Hand System Screw is made of the Titanium Alloy (ASTM F136). This device performance is not adversely affected by aging or storage conditions since this device is to be sterilized at the hospital before use and also to be single use.

The provided text describes the ARIX Hand System, a device for internal fixation of hand and wrist bones, and its 510(k) submission for substantial equivalence to a predicate device. The submission primarily focuses on comparing the ARIX Hand System to the Profyle System, K062498, based on materials, design, intended use, and mechanical properties.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for the ARIX Hand System itself. Instead, it states that "the ARIX Hand System has the similar device characteristics as the predicate device" and that "Only the technical specifications - bending stiffness, tensile strength, driving torque, torsion and pullout - are slightly different." The study performed for the ARIX Hand System involved comparing its mechanical performance to the predicate device. The implicit acceptance criterion is that the ARIX Hand System's performance for these tests should be comparable to or better than the predicate device to establish substantial equivalence. However, specific numerical thresholds for "acceptance" are not provided for either the predicate or the new device, nor are the reported performance values for each.

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

The document does not specify the sample size used for the mechanical tests. The data provenance is not explicitly stated in terms of country of origin of the data or if it was retrospective or prospective. It describes laboratory mechanical tests (e.g., Bending Strength, Tensile Strength, Driving Torque, Torsion, Axial Pullout Strength) which are typically conducted in a controlled environment, not on patient data.

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

This question is not applicable in this context. The "test set" consists of mechanical tests on the device components (plates and screws), not on clinical data requiring expert human review to establish ground truth.

4. Adjudication Method for the Test Set

This question is not applicable as the "test set" involves objective mechanical property measurements, not subjective evaluations that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes mechanical bench tests to demonstrate substantial equivalence, not a clinical study involving human readers or cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical implant (bone plate and screw system), not an algorithm or software. Therefore, human-in-the-loop or standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on objective mechanical performance metrics obtained from standardized tests (e.g., ASTM F382, ASTM F543). The comparison is made against the mechanical properties of a legally marketed predicate device.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical implant, not an AI/ML algorithm that requires a training set. The evaluation focuses on its mechanical properties.

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

This question is not applicable. As stated above, the device is not an AI/ML algorithm requiring a training set.

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