(151 days)
-Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.
-Fixation of proximal tibial metaphysis osteotomy.
-Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula, and sternum.
The proposed MedShape DynaClip® Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip® Bone Staple is intended to be used for fracture and osteotomy fixation, including joint arthrodesis, and fixation of small bone fragments, and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical lmplants). The staple is provided pre-loaded on a disposable inserter.
The provided FDA 510(k) summary for the MedShape DynaClip® Bone Staple (K220812) does not contain information related to a study involving image analysis, AI, or human reader performance.
Instead, this document describes a bone staple, which is a physical medical device intended for fracture and osteotomy fixation. The acceptance criteria and the study proving the device meets these criteria are based on mechanical testing, material characterization, and biocompatibility assessments, not on performance in interpreting medical images or improving human interpretation.
Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria and studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) as they pertain to image analysis or AI/human-in-the-loop performance, because this information is not present in the provided text.
The closest relevant information, regarding performance testing to support substantial equivalence, is listed as:
- Corrosion resistance testing per ASTM F2129
- Transformation temperature thermal analysis testing per ASTM F2004-17
- Bacterial endotoxin testing per ANSI/AAMI ST72:2011
- Mechanical comparison via Finite Element Analysis
The document explicitly states: "No clinical data was collected, as it was deemed unnecessary to support the assertion of safety." This further confirms that no studies involving human or AI interpretation of images were conducted or are described here.
§ 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.