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The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula, in patients with normal bone density and osteopenic bone, for the following indications:

· osteotomies, mal-unions, and non-unions

· single, segmental, and comminuted fractures

The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-271mm in length.

The provided text is related to a 510(k) premarket notification for the "VariAx 2 Compression Plating System". This document is a regulatory submission for a medical device (bone fixation appliance), not an AI/ML powered device, and therefore does not contain information about acceptance criteria or studies as they relate to AI/ML device performance.

The document states: "Clinical testing was not required for this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device from this text. The questions posed in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are specific to AI/ML device evaluation, which is not applicable to the content of this regulatory submission.

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The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:

• osteotomies, mal-unions, and non-unions .
• single, segmental, and comminuted fractures .
• normal bone density and osteopenic bone .

The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.

This document describes a 510(k) submission for the VariAx 2 Compression Plating System, a medical device for internal fixation of bone fractures.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing" and "The following testing was performed: - Compression Plates Screw Through Compression Hole 0° and 15° Angulation with VariAx Screws." This implies physical testing of device samples rather than a data-driven test set for an algorithm. The number of physical units tested is not provided.
• Data Provenance: Not applicable in the context of an AI/algorithm-based device. This is a traditional medical device submission based on mechanical testing.

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

• Not applicable. Ground truth as typically understood for AI models (e.g., expert annotations) is not relevant for this type of mechanical device submission.

4. Adjudication method for the test set

• Not applicable. This is a traditional medical device submission based on mechanical testing, not a clinical study involving human readers or adjudicators for a test set.

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 plate and screw system, not an AI or imaging diagnostic device.

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

• Not applicable. This is a mechanical medical device, not an algorithm.

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

• For this mechanical device, the "ground truth" would be established by engineering specifications and mechanical testing standards. The performance of the modified plates (e.g., strength, stiffness, fatigue resistance) is measured against established benchmarks and compared to the predicate device's performance. The document only broadly states "testing demonstrated that the modified plates are substantially equivalent to the previously cleared K130009," without detailing the specific engineering metrics or benchmarks.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an algorithm that requires a training set.

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

• Not applicable. No training set was used.

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The Stryker VariAx 2 Compression Plating System is intended for internal fixation of bones in adult patients.

The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:

• osteotomies, mal-unions, and non-unions
• single, segmental, and comminuted fractures
• normal bone density and osteopenic bone

The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.

The provided document is a 510(k) summary for the VariAx 2 Compression Plating System, which is a medical device for internal fixation of bone fractures. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting new clinical studies with detailed acceptance criteria and performance metrics for the new device as would be the case for a novel AI/software medical device.

Therefore, many of the specific questions regarding acceptance criteria, study design, expert involvement, and ground truth, as typically applied to AI/ML device evaluations, are not directly applicable or available in this document.

Here's an attempt to address your questions based on the provided text, highlighting where information is not present or not relevant to this type of device submission:

Acceptance Criteria and Device Performance (Based on provided text)

Study Details (Based on provided text)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. The submission relies on non-clinical laboratory testing (dynamic fatigue testing) to demonstrate substantial equivalence, not a clinical test set with patient data.
   • Data Provenance: Not applicable for a clinical test set. The non-clinical testing was performed for the VariAx 2 Compression Plating System components.

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

   • Not applicable. This device underwent non-clinical testing, not a clinical study involving expert-established ground truth on a test set.

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

   • Not applicable. No clinical test set.

4. 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. This is a traditional medical device (bone plating system), not an AI/ML powered device. Therefore, no MRMC study or AI-related effectiveness was assessed.

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

   • No. This is a hardware medical device; there is no algorithm or software for standalone performance evaluation in the context of AI.

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

   • Not applicable in the sense of clinical ground truth for AI/ML devices. The "ground truth" for this submission would be engineering standards and requirements for mechanical performance and materials, verified through non-clinical testing.

7. The sample size for the training set:

   • Not applicable. There is no training set for this traditional medical device.

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set.

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