(74 days)
The Compression Staple and Simple Staple are indicated for fixation of bone fractures or bone reconstruction.
The Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono The Compression Stapic Is mondoe to e as as a netatarsophalangeal arthrodesis, Akin osteotomy, of bl-offical Usteolomics in the forelood first mich of osteotomies for hallux valgus treatment (Scarf and Chevron), and atthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The Simple Staple is intended to be used for wedge osteotomy of the first phalanx (Akin The Smiple Staple 18 Intendod to be assus in order to correct a remaining valgus or pronation of the first ray, and external rotation, and wind-swept toes.
The design features of the Compression Staple are summarized below:
- Manufactured from stainless steel .
- . 10 sizes
- Barbs to prevent back out .
- Diamond shape slot compression feature ●
The design features of the Simple Staple are summarized below:
- Manufactured from stainless steel
- Barbs to prevent back out t
The provided text is a compilation of FDA 510(k) summary documents for the "Compression Staple and Simple Staple." These documents confirm that the device is substantially equivalent to previously cleared fixation staples and provide details on its intended use and design features.
However, the provided text does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed metrics requested in your prompt.
The document states: "The safety and effectiveness of the Compression Staple and Simple are adequately supported by the effectiveness of the Compression Blapts and Billproation, and analysis data provided within this Premarket Notification." This implies that data was provided, but the specifics of that data (acceptance criteria, study details, sample sizes, ground truth, etc.) are not included in the text you've provided.
Therefore, I cannot populate the table or answer your questions based on the given input. The prompt specifically asks to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" from the input. Since this information is absent in your input, I cannot generate it.
§ 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.