(65 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 but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.
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The provided document is a 510(k) summary for the Stryker® Leibinger Universal Distal Radius System, a medical device for internal fixation of small bone fractures. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria for device performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Such studies, often involving clinical trials or performance testing with defined endpoints and statistical analyses, are typically submitted as part of the 510(k) application itself but are usually not detailed in the publicly available 510(k) summary.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size for a test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
The document primarily states the device's intended use and declares its substantial equivalence to predicate devices (K981283, K961496, and K014263). The substantial equivalence determination by the FDA implies that the new device is as safe and effective as a legally marketed device and does not require explicit proof of performance against new, separate acceptance criteria in the summary.
§ 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.