(60 days)
The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis.
The indications for the Smith & Nephew MAVERICK External Fixation System are the following:
- Open and closed fracture fixation
- Bony or soft tissue deformities
The subject of this premarket notification is the MAVERICK External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.
The provided text is a 510(k) Premarket Notification from the U.S. FDA for the MAVERICK External Fixation System. It details the device's intended use, regulatory classification, and comparisons to predicate devices. However, the document does not contain information about a study proving the device meets acceptance criteria related to AI/Machine Learning performance, diagnostic accuracy, or human reader improvement with AI assistance.
The performance testing section (on page 4) exclusively describes mechanical bench testing of the device's components and full constructs, such as grip strength, resistance to slip, and cyclic testing of frames. This type of testing is standard for orthopedic devices to demonstrate structural integrity and durability, not diagnostic accuracy or AI performance.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding:
- A table of acceptance criteria and the reported device performance for an AI/diagnostic device. The provided "Device Testing" table lists mechanical tests, not diagnostic performance metrics.
- Sample size used for the test set and data provenance: No such data is mentioned.
- Number of experts used to establish ground truth and their qualifications: Not applicable to mechanical testing.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document is about a Class II medical device for temporary stabilization of bones, and the "study" described is entirely focused on mechanical performance and biocompatibility, not on diagnostic accuracy or AI-powered assistance.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.