(64 days)
The Parcus ATLAS is indicated for CMC Arthroplasty.
The Parcus ATLAS is designed for use in CMC arthroplasty. The ATLAS is comprised of medical grade titanium, PEEK-OPTIMA™ from Invibio™, and UHMWPE. The ATLAS is provided sterile.
The documents provided do not contain information related to software or AI/ML-driven devices. The submission (K190375) describes a mechanical medical device, the Parcus ATLAS, which is indicated for CMC (Carpometacarpal) arthroplasty. This device is composed of titanium, PEEK-OPTIMA™, and UHMWPE.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this text. The provided text primarily focuses on substantial equivalence to predicate devices, material composition, manufacturing, sterilization, and basic mechanical performance testing (tensile loading).
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.