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The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the VariAx 2 Distal Radius System. This line extension consists of anatomically pre-contoured plates for the treatment of simple and complex fractures of the distal radius, together with specialized instrumentation. All new plates are manufactured from CP Ti Grade 2 (Type II anodization) and are available in different sizes and left/right versions. The plates will be provided both non-sterile and sterile-packaged. They will use the well-established SmartLock technology to allow variable angle screw locking. The plates can be used with non-locking and locking VariAx 2 T8 screws. The VariAx 2 T8 screws have been previously cleared under K191412.

The provided text is an FDA 510(k) clearance letter for the Stryker VariAx 2 Distal Radius System. This document does not contain information about software performance, AI algorithms, or any type of study that would involve acceptance criteria for an AI/software device.

The document discusses a physical medical device (bone fixation plates and screws) and primarily relies on non-clinical performance data comparing the new device to previously cleared predicate devices. The performance data listed (engineering assessment, biomechanical tests, MR safety assessment, packaging tests, biocompatibility) are all related to the physical properties and safety of the implantable hardware, not software or AI performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them, as the provided input does not describe such a study or device.

To fulfill your request, you would need to provide a document related to the clearance of a software as a medical device (SaMD) or a device that incorporates an AI/ML component.

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The VariAx 2 Distal Radius System is indicated for the fixation of fractures, nonunions, and malunions of the bones of the hand and wrist, including osteopenic bone.
The VariAx 2 Distal Ulna System is indicated for the fixation of fractures, nonunions, and malunions of the wrist, including osteopenic bone.

The distal radius plates consist of an anatomically shaped Dorsal DR Plate for the double column DR fractures. The anatomically shaped Dorsal Lateral DR, Dorsal Medial DR, Lateral DR and Volar Rim DR plates are used for fragment specific plating of the distal radius. Lateral DR plate for the radial styloid fractures, a Dorsal Medial DR Plate and a Dorsal Lateral DR Plate for the medially or laterally displaced dorsal DR fractures, and a Volar Rim DR Plate for the volar rim DR fractures. The Lateral DR plate, Dorsal Medial DR and Dorsal Lateral DR plates will provide screw/peg fixation of the distal DR fragments as an optional to fixation with K-wires. The Wrist Spanning plate is intended for temporary internal fixation of the comminuted distal radius fractures and wrist and serves as an alternative to an External Fixator. Additionally, it can be applied for complementary stabilization in combination with the other fracture fixation plates.
The VariAx 2 Distal Ulna (DU) plates consist of the DU Base Plate and the DU Hook Plate. The DU hook plate is used for fixation of ulnar styloid fractures and the DU base plate is used for fractures of the distal ulnar head and/or shaft.
All new VariAx 2 implants will use the well-established SmartLock technology to allow variable angle screw locking. The plates will be available non-sterile in VariAx 2 Wrist Tray, and also sterile-packaged. The plates can be used with non-locking and locking VariAx 2 T8 screws. The VariAx 2 T8 screws have received 510(k) clearance (K180500).
All plates (except the Wrist Spanning plate) are made from CP Ti Grade 2 (anodized Type II). The Wrist Spanning plate is made from Ti Alloy (Ti6Al4V ELI).

This document describes the regulatory clearance (K212581) for the VariAx 2 Distal Radius System and VariAx 2 Distal Ulna System, which are single/multiple component metallic bone fixation appliances and accessories.

Crucially, this document is a 510(k) summary for a medical device that is not an AI-powered diagnostic or therapeutic device. It's a traditional mechanical orthopedic implant. Therefore, the questions related to AI-specific acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set sample sizes for AI algorithms are not applicable to this device.

The study described in this document focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than clinical performance or AI algorithm validation.

Here's a breakdown based on the provided text, addressing the relevant points and explaining why others are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (metallic bone fixation), acceptance criteria are typically defined by engineering and mechanical performance standards, ensuring the device is robust enough for its intended use and performs at least as well as legally marketed predicate devices.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in terms of clinical cases or patient data, as the validation was primarily non-clinical (mechanical testing of physical devices). The "test set" here refers to the number of physical devices/components subjected to mechanical and MR compatibility testing. The exact number of units tested per mechanical test is not provided in this summary but would be detailed in the full test reports.
• Data Provenance: The data comes from bench testing conducted by the manufacturer, Stryker GmbH. It is inherently "prospective" in the sense that the tests were designed and executed to evaluate the new device's performance against predefined standards. There is no indication of country of origin for "data" as it relates to patient information, as no clinical data was used for substantial equivalence.

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

Not applicable. Ground truth for mechanical performance is established by engineering principles and standardized test methods (e.g., ASTM standards), not by human expert consensus or interpretation of images.

4. Adjudication method for the test set

Not applicable. As described above, there's no expert interpretation or consensus needed for the mechanical and physical property tests performed.

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

Not applicable. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

The "ground truth" for this device's performance is objective, quantifiable mechanical and physical properties as defined by international standards (e.g., ASTM, ISO). It's based on:

• Engineering measurements
• Material science properties
• Adherence to established performance benchmarks (demonstrating equivalence to predicate devices and resistance to various forces/conditions).

8. The sample size for the training set

Not applicable. There is no AI model involved, so there's no training set for an algorithm.

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

Not applicable. There is no AI model involved, so no ground truth for a training set was established.

Summary of Device and its Validation Approach:

The VariAx 2 Distal Radius and VariAx 2 Distal Ulna Systems are orthopedic implants. Their regulatory clearance (K212581) was based on demonstrating substantial equivalence to existing predicate devices already on the market. This was achieved primarily through non-clinical performance testing, specifically mechanical and material property tests (e.g., bending, torque, push-out force, and MR compatibility). The testing showed that the new devices perform at least as safely and effectively as their predicate counterparts, and do not raise new questions of safety or effectiveness. Clinical data was explicitly stated as "not needed" for this demonstration of substantial equivalence.

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