(94 days)
The Flower Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstructions of bones of the rearfoot, including the calcaneus. Examples of these internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.
The Flower Rearfoot Plating Set consists of the following components and accessories: calcaneal plates, MIS calcaneal plates, and calcaneal step osteotomy plates, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.
The provided text describes a 510(k) premarket notification for the "Flower Rearfoot Plating Set," a medical device for internal fixation of rearfoot fractures and reconstructions.
However, the document does not contain the kind of information requested in the prompt, such as acceptance criteria, reported device performance in a clinical study, sample sizes, ground truth establishment methods, expert qualifications, or details about any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance study.
The primary purpose of this 510(k) summary is to demonstrate substantial equivalence to predicate devices through engineering analysis and Finite Element Analysis (FEA), focusing on mechanical strength and technological characteristics rather than clinical performance metrics in humans or AI-assisted diagnostic improvements.
Therefore, I cannot populate the requested table or answer the questions related to clinical study design, ground truth, or AI performance based on the provided text.
The information available from the text is:
- Device Name: Flower Rearfoot Plating Set
- Intended Use/Indications for Use: Internal fixation of fractures and reconstructions of bones of the rearfoot, including the calcaneus (e.g., extra-articular, intra-articular, joint depression, tongue type, severely comminuted fractures, and osteotomies).
- Method of Performance Demonstration:
- Engineering analysis to demonstrate appropriate mechanical strength.
- Finite Element Analysis (FEA) to compare physiological loading of the subject device and predicate devices, confirming at least equivalent strength.
- Ground Truth (for mechanical testing): The "ground truth" in this context is the expected mechanical behavior and strength of the predicate devices. The study aimed to show the subject device's mechanical equivalence to these established devices through engineering principles and simulation.
In summary, the provided document does not contain the information necessary to address the prompt's request for clinical acceptance criteria, device performance, or details of a study involving human readers or AI in a diagnostic context.
§ 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.