(208 days)
restor3d Pin Implants are indicated for maintenance of alignment and fixation of bone fractures, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
restor3d pin implants are made from implant grade titanium alloy using an additive manufacturing process and possess a porous surface structure of unique topology. Pin implants are designed for use in a variety of surgical procedures including fixation of fractures, osteotomies, arthrodesis and as bone graft in the presence of additional immobilization. The pin implants are offered in a range of diameters, permitting surgeons to choose a relevant size for the affected anatomy.
The provided document is a 510(k) premarket notification for the "restor3d Pin Implants." This document pertains to a physical medical device (bone fixation pins) and describes its mechanical testing and comparison to predicate devices to demonstrate substantial equivalence for FDA clearance.
Therefore, the requested information regarding acceptance criteria and a study proving a software device meets those criteria is not applicable to this document. The document describes benchtop performance tests for a physical implant, not a software device or algorithm.
Specifically, the document states:
- "The proposed restor3d device was subject to the following benchtop performance tests to support the assertion of substantial equivalence: Bending Testing, Shear Testing, Pullout Testing."
- "No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Pin Implants are considered substantially equivalent to the predicate devices."
This indicates that mechanical performance criteria (bending, shear, pullout) were established and tested on the physical device to show it is comparable to existing devices, but these are not acceptance criteria for a software algorithm's performance.
§ 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.