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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 Foot System (2.3/2.8) is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusion, corrective osteotomies, and the treatment of fractures.

The ARIX Foot System (2.3/2.8) is rigid fixation consisting of plates and screws in various confiqurations, shapes and sizes. The ARIX Foot System (2.3/2.8) is made of Unalloyed 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 screws are self-tapping with various diameters, which are applied with the reconstruction locking screws together. The Cortical Screws, locking screws & self-drilling screws are provided with diameter 2.0 mm to 2.8 mm and lengths from 6 mm to 46 mm.

The provided document is a 510(k) premarket notification for a medical device called the "ARIX Foot System (2.3/2.8)". This notification focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and bench testing, rather than reporting on the performance of an AI-powered diagnostic device or a study involving human readers.

Therefore, many of the requested categories for AI/diagnostic device performance studies, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment methods, are not applicable to this document. The document explicitly states: "No clinical studies were considered necessary and performed."

However, I can extract information related to the acceptance criteria and the study that proves the device meets them, based on the non-clinical testing performed.

Here's the breakdown, focusing on the information available:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical values or ranges. Instead, it states that the device complies with recognized standards for metallic bone plates and screws. The reported device performance is that the "results of this testing indicate that the ARIX Foot System (2.3/2.8) is equivalent to predicate device."

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

• Sample size for test set: The document does not specify the exact number of plates or screws tested for each non-clinical test. It generally refers to "bench tests" being conducted.
• Data provenance: The tests were conducted by Jeil Medical Corporation, located in Seoul, Korea. The data is prospective in the sense that these were specific tests performed for this submission, not analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The "ground truth" for mechanical testing is based on engineered specifications and industry standards (ASTM standards), not human expert interpretation.

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

This is not applicable. Adjudication methods are relevant for interpreting subjective assessments or diagnoses, not for objective mechanical tests.

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, an MRMC comparative effectiveness study was not done. This device is a metallic 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

This is not applicable. This device is a physical medical implant, not an algorithm.

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

The "ground truth" in this context is defined by the established mechanical properties required by the ASTM standards (ASTM F382 and ASTM F543) and the observed performance of the predicate devices. It is a technical ground truth based on engineering specifications and material science, not a medical "ground truth" for diagnosis.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This is not applicable for the reasons mentioned above.

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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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The ARIX Diaphysis System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

The ARIX Diaphysis System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Diaphysis System is made of Unalloyed Titanium and 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 3.5 mm and lengths from 10 mm to 100 mm.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical bench testing. Therefore, there are no human subject test sets or associated data provenance (e.g., country of origin, retrospective/prospective). The "test set" in this context refers to the physical devices (plates and screws) subjected to mechanical testing. The sample size for these tests is not explicitly stated in numerical terms (e.g., "n=X plates," "n=Y screws"), but the phrase "The following tests were performed with the predicate device" implies a comparison between the subject device and the predicate device for each test.

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

Not applicable. This was a non-clinical bench study. The "ground truth" for mechanical testing is established by the ASTM standards and the measured physical properties of the devices. No human experts were used to "establish ground truth" in the way they would for medical image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical bench study, there was no adjudication method involving multiple experts or consensus for the "test set" in the context of human data. The compliance was determined by objective measurements against established engineering standards.

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

No. The document explicitly states: "No clinical studies were considered necessary and performed." This study is a non-clinical bench study focused on mechanical performance and equivalence to predicate devices, not a clinical trial involving human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device (bone fixation system), not an algorithm or AI software. Therefore, there is no "standalone algorithm only performance" to assess.

7. Type of Ground Truth Used

The "ground truth" for this study was engineering standards and mechanical test results. Specifically:

• ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates)
• ASTM F543 (Standard Specification and Test Method for Metallic Medical Bone Screws)
• Comparative mechanical properties (e.g., torsional strength, pull-out strength, bending, fatigue) relative to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a medical device and not an AI or machine learning system that requires a "training set."

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

Not applicable, as there is no training set for this type of medical device.

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