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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 VariAx Elbow System Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

The subject VariAx Elbow System is comprised of plates and screws, manufactured from Titanium alloy and Commercially Pure Titanium. The subject system was determined substantially equivalent in K073527. This Special 510(k) submission is intended to address the addition of the 7mm washer to the predicate VariAx Elbow System.

This 510(k) summary describes a line extension for the VariAx Elbow System, adding a 7mm washer. As such, the study primarily focuses on demonstrating the substantial equivalence of the new component to existing predicate devices, rather than establishing new performance criteria for a novel device.

Here's an analysis of the provided information, framed by your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a line extension for an existing bone fixation system, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence for the added component. The primary acceptance criteria for this type of device extension would be:

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

The document states "Functional and mechanical testing" was performed. However, it does not specify the sample size for these tests for the new 7mm washer.

The data provenance is prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate equivalence. The country of origin of the data is not specified, but it can be inferred to be from the manufacturer (Howmedica Osteonics Corp.) in the USA.

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

This type of information is not applicable to this submission. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols, not by expert consensus. There are no clinical images or diagnostic interpretations requiring expert radiologists or other medical professionals for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objective measurements and do not require adjudication by human experts.

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 type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images. The VariAx Elbow System Line Extension is a mechanical implant, not an AI or diagnostic device.

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

No, a standalone (algorithm only) performance study was not done. This is not an AI or software-only device.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be established by validated engineering principles and standards for bone fixation devices. This might include standards for fatigue strength, torsional strength, bending strength, etc., depending on the specific mechanical tests performed. The document implies that the "comparable mechanical & functional properties" were assessed against the predicate device, which would have itself been evaluated against such standards.

8. The Sample Size for the Training Set

There is no training set mentioned or implied because this is a mechanical device undergoing physical testing, not a machine learning model.

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

This is not applicable as there is no training set.

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