(180 days)
The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction. Examples include:
-
Wedge osteotomy of the first phalanx (Akin osteotomy)
-
Treatment of hallux valgus in order to correct valgus or pronation of the first ray
-
Wind swept toes
The Small Staple is intended for single use only
The EPIC Extremity Small Staple will consist of one size and style, and instruments to assist in implanting the device.
This document, K163226, is a 510(k) premarket notification for the EPIC Extremity Small Staple. It concludes that the device is substantially equivalent to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.
Instead, this document focuses on demonstrating substantial equivalence based on:
- Intended Use and Indications for Use: Stating they are similar to the predicate device.
- Technological Characteristics: Highlighting similarities in materials and size range.
- Non-Clinical Performance Data: Comparing the subject device's static bend testing, fatigue bend testing, and pullout testing performance to the predicate device.
- Clinical Performance Data: Explicitly stating that "No clinical testing was required."
Therefore, based on the provided text, I cannot answer the requested questions about acceptance criteria or a study proving device performance in the context of AI/ML. The provided information pertains to the physical characteristics and mechanical performance of a medical staple for bone fixation, not an AI/ML device.
§ 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.