(23 days)
The KLS Martin Hand Distractor is designed to be used in finger reconstruction of the thumb or the metacarpal bones I - IV after amputation or malformation.
The KLS Martin Hand Distractor is a subcutaneous bone distractor. It features two telescoping jackscrew components activated by, fixed to the bone with plates and secured with titanium bone screws.
The provided text is a 510(k) summary for the KLS-Martin Hand Distractor. It describes the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using the provided input. The document is solely focused on demonstrating substantial equivalence to existing legally marketed devices, which is a regulatory pathway that often relies on comparison to predicate devices rather than new performance studies.
§ 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.