(90 days)
APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.
The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Hand Plates, previously cleared under K102537.
The subject device APTUS Hand Scaphoid Plates is available in three designs - small, standard, large - all with 6 screw holes. All plates have anatomical designs that are appropriate for the scaphoid. The subject device plates are compatible with screws and k-wires previously cleared in K102537, K051567, K232144 (for srews), K092038, K202589 and K232144 (for k-wires).
The subject device plates are manufactured from unalloyed titanium conforming to ASTM F67, and are provided non-sterile and sterile.
This document is a 510(k) Premarket Notification from the FDA regarding the "APTUS Hand Scaphoid Plates." It outlines the regulatory review and states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/Software as a Medical Device (SaMD) product.
Instead, this document pertains to a physical medical device (bone fixation plates) and references mechanical testing to demonstrate performance and substantial equivalence to predicate devices, not AI performance.
Therefore, I cannot fulfill your request as the required information (acceptance criteria for an AI/SaMD product, details of an AI performance study, number of experts, ground truth establishment, etc.) is absent from the provided text.
The document explicitly states: "Clinical data were not provided in this submission." and refers to "Mechanical fatigue and static testing" as the non-clinical testing performed.
To complete your request, I would need a regulatory submission document for an AI/SaMD product that discusses its performance characteristics, acceptance criteria, and the study conducted to demonstrate its capabilities.
§ 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.