(66 days)
Memory 12 and Memory 20 staples are implants intended for fixation of the foot.
Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.
The patient's anatomy and skeleton must be capable of receiving the selected implant.
The Memory Staple is a single-use, bone fixation appliance intended to be implanted in the foot. It is a bicortical compression staple manufactured from a Nickel-Titanium alloy.
The provided text is a 510(k) Summary for a medical device called the "Memory™ Staple." It details the device's description, intended use, indications for use, and a statement of substantial equivalence to a predicate device.
However, the document does not contain information related to acceptance criteria or a study proving the device meets acceptance criteria. This type of information would typically be found in a performance data section, which is absent from this summary.
Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details) because the provided text does not contain any of this information.
The document primarily focuses on establishing substantial equivalence to a previously cleared device (DePuy Memory Staple, K964226) based on similarities in intended use, indications for use, materials, and design. This suggests that the regulatory submission relied on the established safety and effectiveness of the predicate device rather than presenting new clinical or performance study data for the new device itself.
§ 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.