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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 Foot System 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 fusions, corrective osteotomies, and the treatment of fractures.

The ARIX Foot System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Foot System 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. 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 are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 50 mm. ARIX Foot System is provided as blue 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 quide pins, drill bits and driver shafts, washers, drill sleeve, depth gauge, bender, cleaning stylet and screw driver handle. The ARIX Foot System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery.

The provided text describes the regulatory clearance for the ARIX Foot System, a medical device for internal fixation, reconstruction, or arthrodesis of small bones. It outlines the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML algorithm or diagnostic device.

The document specifically states under "Clinical Test Summary" that "No clinical studies were considered necessary and performed." This indicates that the regulatory clearance was based on non-clinical (bench) testing and substantial equivalence to existing devices, not on a study with human subjects, AI assistance, or expert ground truth determination.

Therefore, most of your requested information regarding acceptance criteria for an AI/ML device and the study proving it are not applicable to this document.

However, I can extract the information that is present:

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

• Acceptance Criteria (Non-Clinical): The device must comply with ASTM F382-99 (Standard Specification and Test Method for Metallic Bone Plates) and ASTM F543-07 (Standard Specification and Test Methods for Metallic Medical Bone Screws).
• Reported Device Performance: The bench tests (tensile strength test, bending strength test per ASTM F382) indicated that the ARIX Foot System is "equivalent to predicate device" and "met all design specifications."

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

• Not applicable. This was a non-clinical, bench testing study on the device itself, not a study involving a test set of data (e.g., medical images) from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth for an AI/ML device is not relevant here as there's no AI component or human interpretation being evaluated. The "truth" in this context is adherence to engineering standards.

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

• Not applicable.

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. The document explicitly states "No clinical studies were considered necessary and performed." There is no mention of AI assistance or human readers.

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

• No. This is not an algorithm-based device.

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

• The "ground truth" equivalent in this non-clinical context would be the engineering specifications and ASTM standards (ASTM F382-99, ASTM F543-07). The device's performance was measured against these established standards.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not applicable. There is no training set mentioned.

Ask a specific question about this device

The ARIX Foot System 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 fusions, corrective osteotomies, and the treatment of fractures.

The ARIX Foot System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Foot System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67 and ASTM F136. The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with various diameters. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 50 mm, lag screws (Cannulated and Cannulated Headless Types) with diameters of 1.5 mm to 6.0 mm and lengths of 8 mm to 80 mm. It also includes various manual surgical instruments, such as guide pins, drill guides, drill bits and driver shafts, washers, drill sleeve, depth gauge, bender, cleaning stylet and handbody. The ARIX Foot System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery.

The provided 510(k) summary describes the ARIX Foot System, a medical device for bone fixation. However, it does not contain the kind of detailed information about acceptance criteria, study design, and performance metrics as typically expected for evaluating AI/algorithm-based devices with standalone performance or human-in-the-loop improvements. This summary pertains to a traditional medical implant, and the assessment is based on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and study presented.

Here's a breakdown of the available information based on the prompt's requirements:

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

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

This information is not provided in the document. For bench testing, "sample size" would refer to the number of plates and screws tested per standard. Data provenance is not applicable as this involves non-clinical bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this device relies on objective engineering standards (ASTM) for performance, not expert-derived ground truth from patient data.

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

This information is not applicable as this device relies on objective engineering standards (ASTM) for performance, not expert-derived ground truth from patient data requiring adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone fixation system, not an AI or imaging diagnostic tool that would typically involve human readers.

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

No, this information is not applicable. This is a physical medical implant, not a software algorithm.

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

For the non-clinical tests, the "ground truth" or reference standard used was the specifications and test methods defined by ASTM F 382-99 (for plates) and ASTM F 543-07 (for screws).

8. The sample size for the training set

This information is not applicable. This device is a physical product, not a machine learning model that requires a "training set."

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

This information is not applicable for the reasons stated above.

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