(191 days)
Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following:
- Cervical fractures
- Ligamentous injury of the cervical spine
- Fusion or other surgery of the cervical spine
The skull pins, which pass through the halo ring or tong, are the only invasive component of the DePuy ACE cervical traction device. The new skull pins, ring and tong (fixed tip and spring loaded), now include a zirconia insert between the pin body and the pin tip. The zirconia insert eliminates the possibility of an electrical current passing to the patient which may cause a burning sensation at the pin insertion points.
The provided text is a 510(k) Summary for a medical device (DePuy ACE Skull Pins - MRI compatible) and the FDA's acceptance letter. It describes the device, its intended use, and argues for its substantial equivalence to previously approved devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/ML device evaluations.
This is because the device described, "DePuy ACE Ring Skull Pin - MRI", is a physical medical device (pins, tongs, and halo rings for cervical spine stabilization), not an AI/ML-driven diagnostic or prognostic tool. For such physical devices, the "acceptance criteria" and "study" would typically refer to bench testing, material biocompatibility testing, mechanical strength testing, and potentially clinical performance studies comparing the new device's physical properties or patient outcomes to a predicate device. These types of studies are not detailed in this 510(k) summary; instead, the summary focuses on establishing substantial equivalence based on design similarity and intended use to pre-amendment devices or previously cleared devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence of a physical device, not on performance metrics of an AI/ML system.
§ 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.