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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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