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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.

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The Stryker VariAx 2 System is intended for internal bone fixation in adult patients.

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:

• Internal fracture fixation;
• Osteotomies:
• Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below:

• T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
  • Compression fractures:
  • Intra-articular and extra-articular fractures;
  • Displaced fractures;
  • Reconstruction procedures;
• T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
  • Intra-articular and extra-articular fractures of the Distal Radius,
  • Displaced and compression fractures of the Distal Radius;
  • Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle;
  • Reconstruction procedures in the Foot & Ankle and Distal Radius:
• T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
  • Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna:
  • Single, segmental and comminuted fractures;
  • Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle:
  • Normal bone density or osteopenic bone.

The VariAx 2 System is an internal fixation device consisting of screws and instrumentation that will be used in conjunction with previously cleared VariAx Plating Systems to treat a number of different types of fractures in the radius, ulna, humerus, clavicle, foot, and fibula. These screws can be used in conjunction with said plating systems, or in the case of non-locking screws, may also be used independently using a lag screw technique. The subject components will be available sterile and non-sterile.

The VariAx 2 System is a medical device designed for internal bone fixation. Its acceptance was determined through non-clinical laboratory testing, demonstrating substantial equivalence to previously cleared predicate devices.

1. Acceptance Criteria and Reported Device Performance:

Note: The document does not provide specific numerical values for the acceptance criteria or reported performance. The "acceptance criteria" and "reported device performance" are inferred from the statement "Testing demonstrated that the VariAx 2 System is substantially equivalent to the predicate devices currently cleared for marketing."

2. Sample Size and Data Provenance for Test Set:

• Sample Size: The document does not specify the sample size used for each non-clinical test.
• Data Provenance: Not applicable as the testing was non-clinical laboratory testing. The country of origin for the sponsor, Stryker Trauma AG, is Switzerland.

3. Number and Qualifications of Experts for Ground Truth:

Not applicable. The regulatory pathway for this device (510(k)) focuses on substantial equivalence through non-clinical testing for fracture fixation systems, not on human expert assessment for image interpretation or diagnosis. Therefore, no experts were used to establish ground truth in the context of image interpretation.

4. Adjudication Method for Test Set:

Not applicable. This was a non-clinical device testing study, not a clinical study involving human judgment or interpretation requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states, "Clinical testing was not required for this submission."

6. Standalone Performance Study:

Yes, in a way. The non-clinical laboratory tests assess the performance of the device components (screws and plate-screw constructs) in isolation, under controlled laboratory conditions, to determine their mechanical properties and functional equivalence to predicate devices. This represents an "algorithm only without human-in-the-loop performance" in the context of a physical device's mechanical integrity.

7. Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria was based on engineering and mechanical performance benchmarks established by predicate devices and recognized industry standards for bone fixation appliances. These benchmarks are inherently quantitative and objective, derived from physical testing.

8. Sample Size for the Training Set:

Not applicable. This device is a physical bone fixation system, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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 submission.

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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 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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The VariAx™ Elbow System is intended for fracture fixation of long bones. Indications include:

• Distal Humerus
• Proximal Ulna

This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Elbow System are intended to add different types of plates and screws to the Stryker® Plating System portfolio.

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the VariAxTM Elbow System, focusing on its substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and its substantial equivalence to other Stryker plating systems.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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