Search Results

Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal, or orthogonal application.

The VariAx™ Distal Radius Torx Screws in combination with the plates from the Stryker® Leibinger Universal Distal Radius System are designed to treat various types of fractures of the distal radius.

Here's a breakdown of the acceptance criteria and study information for the VariAxTM Distal Radius Torx Screws, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not contain information regarding a specific "test set" in the context of an AI/algorithm-based device. The study described is mechanical testing comparing the new device to predicate devices. Therefore, details like sample size for a test set, data provenance (country of origin, retrospective/prospective) are not applicable or mentioned.

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

This information is not applicable as the described study is mechanical testing of physical implants, not an AI or diagnostic device that requires expert-established ground truth from a test set of medical data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a medical implant (bone screws and plates) and focuses on mechanical equivalence to existing predicate devices, not on the diagnostic accuracy or effectiveness of an AI system with or without human assistance.

6. If a Standalone (Algorithm Only) Performance Study was done

No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on the mechanical properties of the predicate devices. The new device's performance is compared against these established mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of mechanical testing of a medical implant.

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

This information is not applicable for the same reasons as point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a mechanical testing study. The VariAx™ Distal Radius Torx Screws were subjected to mechanical tests, and their performance was directly compared to the mechanical properties of two predicate devices: the Stryker® Leibinger Universal Distal Radius System and the Stryker® Foot System.

The acceptance criterion was that the new device's mechanical properties should be "comparable" to those of the predicate components. The study concluded that the "Mechanical testing demonstrated comparable mechanical properties to the predicate components," thereby establishing substantial equivalence. This type of equivalence demonstration is common for medical devices that are modifications or iterations of existing, legally marketed devices.

Ask a specific question about this device