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The Variax Elbow System Plate 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 quivalent in K073527. This Special 510(k) submission is intended to address the shortening of the Distal Posterior Medial Humeral Plates, left and right. Two process changes, which have been documented internally and affect the entire Distal Posterior Medial humeral Plate family, are also discussed.

This document describes a Special 510(k) submission for the VariAx Elbow System Plate Line Extension. This is not a study focused on diagnostic accuracy or AI performance in the traditional sense. Instead, it is a submission for a medical device (bone plates and screws) and primarily discusses its substantial equivalence to a previously cleared predicate device.

Therefore, many of the typical acceptance criteria and study design elements requested in a clinical or AI performance study are not applicable to this type of submission. The focus here is on mechanical and functional equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" in the way one might for a diagnostic AI study (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for this device modification is substantial equivalence to the predicate device in terms of mechanical strength and functional properties.

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

• Not Applicable in the context of clinical or AI performance data. This submission relies on mechanical and functional testing of the device itself, not patient data or a "test set" of cases. The "sample" here refers to the number of physical devices tested to demonstrate mechanical properties. The document does not specify the exact number of plates/screws tested, only that mechanical and functional testing was performed.
• Data Provenance: The testing would have been conducted by the manufacturer (Howmedica Osteonics Corp.) in a laboratory setting. There is no "country of origin of the data" in the sense of patient demographics for this type of submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. For a medical device like bone plates, "ground truth" is established through engineering and material science principles, manufacturing specifications, and international standards for mechanical testing. It's not typically established by clinical experts reviewing cases.

4. Adjudication Method for the Test Set:

• Not Applicable. This concept is relevant for studies involving human reviewers or AI output that needs to be assessed for accuracy against a reference standard. For mechanical testing, the results are objective measurements (e.g., load at failure, fatigue cycles).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is for evaluating the impact of a diagnostic aid (often AI) on human reader performance. The VariAx Elbow System Plate Line Extension is a physical device for fracture fixation, not a diagnostic tool.

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

• No. There is no algorithm or AI component to this device. It is a physical bone plate system.

7. The Type of Ground Truth Used:

• For this submission, the "ground truth" for demonstrating device performance would be based on:
  • Mechanical Test Standards: Established international and national standards for testing the strength, fatigue life, and other mechanical properties of bone plates and screws (e.g., ASTM standards).
  • Predicate Device Performance Data: The established and cleared performance metrics of the previously approved VariAx Elbow System (K073527) serve as the benchmark for "substantial equivalence."

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI or machine learning product where a "training set" of data is used. The device is designed and manufactured based on engineering principles and material science.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

In summary: The provided document is for a "Special 510(k)" for a medical device line extension. This type of submission focuses on demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical efficacy studies involving patient data or AI performance metrics. Therefore, many of the typical questions for AI study design are not relevant in this context.

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