(237 days)
The Arthrex ProStop™ Plus Arthroereisis Subtalar Implants are indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.
The Arthrex ProStop™ Plus Arthroereisis Subtalar Implant is a fully threaded, cannulated, tapered screw. It is similar in design to the predicate device MBA Resorb Implant, K051611.
This document is a 510(k) summary for the Arthrex ProStop Plus Arthroereisis Subtalar Implant. It describes the device and its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or details about standalone performance or training sets. This is typical for a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting detailed clinical study results and acceptance criteria in the manner requested.
Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The document primarily focuses on regulatory approval based on demonstrating equivalence rather than a detailed performance study against specific acceptance criteria.
§ 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.