(9 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties comparable to predicate devices | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.