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The VariAx™ Fibula Straight Plates are intended for use in internal fixation of the distal fibula.

This 510(k) submission is intended to add bone plates with a different geometry to the VariAx " fibular plate line which was cleared in K081284. The new plates are termed "Fibula Straight Plates" and consist of the shaft portion of the cleared plate plus an oblong screw hole in some configurations. Additionally, other fixation plates (predicates) have been cleared with the approximate plate length of the subject device, including the Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335).

The provided text is for a 510(k) summary for a medical device (VariAx™ Locked Plating System Line Extension for Addition of Fibula Straight Plates), which is a regulatory document to demonstrate substantial equivalence to a legally marketed predicate device. It does not describe a study involving an algorithm or artificial intelligence, nor does it involve performance criteria typically associated with such technologies.

The acceptance criteria and "study" described here pertain to mechanical and material equivalence for a physical medical implant.

Here's a breakdown based on the provided text, heavily formatted to address your specific points even if they don't perfectly align with the nature of this submission:

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context refer to demonstrating substantial equivalence in mechanical properties to predicate devices. The "reported device performance" indicates that these criteria were met.

Study Details (as applicable to a physical device equivalence study)

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

   • The document does not specify the exact sample size (number of plates tested) for the fatigue and stiffness tests.
   • Data Provenance: The tests were performed to compare the subject device's mechanical properties to predicate devices (Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335)). This is laboratory-generated data, not patient data, and does not have a "country of origin" in the same sense as clinical data. It is a prospective test in that new plates were manufactured and tested for this submission.

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

   • This is not applicable. For mechanical testing of medical devices, "ground truth" is established by standardized testing methods and measurements, not expert human interpretation. The "truth" is objective physical properties.

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

   • None. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or clinical outcomes. This study involves objective mechanical measurements.

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 510(k) for a physical bone plate, not an AI or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

   • No. This is not an algorithm, but a physical medical device.

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

   • The "ground truth" for this submission is based on objective mechanical properties and material composition, established through standardized physical testing (4-point bending test) to compare the subject device to existing predicate devices.

7. The sample size for the training set:

   • Not applicable. This submission describes mechanical testing of a physical device, not an AI algorithm requiring a training set.

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

   • Not applicable. See point 7.

Summary of the "Study" for this device:

The study was a benchtop mechanical comparison of the subject device (VariAx™ Fibula Straight Plates) against predicate devices (Synthes 3.5 mm LCP® Medial Distal Tibia Plates and Synthes One-Third Tubular Dynamic Compression Locking plates).

• Methods: Fatigue strength verification and stiffness analysis were evaluated using a 4-point bending test.
• Findings: The median fatigue limits and stiffness of the VariAx™ Fibula Straight Plates were found to be equivalent to the existing fibula plates in the predicate system.
• Conclusion: This data demonstrated substantial equivalence to the predicate devices, a key regulatory requirement for 510(k) clearance.

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