(307 days)
The Additive Orthopaedics Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
*Cotton (opening wedge) osteotomies of the medial cuneiform
*Evans lengthening osteotomies
The Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation.
The Additive Orthopaedics Bone Wedges are not intended for use in the spine.
The Additive Orthopaedics Bone Wedge System is a series of wedge-shaped devices intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The wedges are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The wedges come in 18 individual sizes and configurations to correct various skeletal deformities in the foot. The Additive Orthopaedics Bone Wedge System is intended to be used with ancillary plating fixation.
I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
The document is a 510(k) premarket notification letter from the FDA to Additive Orthopaedics, LLC regarding their Bone Wedge System. It confirms that the device has been found substantially equivalent to legally marketed predicate devices.
While the document mentions "mechanical testing (including, friction, roughness, durability/abrasion, and compressive fatigue)" and "biocompatibility testing" as part of the "Non-Clinical Evidence" used to demonstrate substantial equivalence, it does not provide:
- Specific acceptance criteria: It states that these activities "demonstrate that the Additive Orthopaedics Bone Wedges are substantially equivalent," but doesn't list the quantitative acceptance thresholds for these tests.
- Detailed study results: It doesn't report the actual performance data from these tests against any acceptance criteria.
- Information related to human reader studies or ground truth establishment: The nature of this device (bone wedges for internal fixation) means that an "AI" component as typically understood in diagnostic software is not applicable here. Therefore, information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details are not relevant or present in this document.
The document primarily focuses on establishing "substantial equivalence" based on similar indications, dimensions, geometry, and materials, supported by general non-clinical testing. It does not contain the detailed study information you requested for an AI/software device.
§ 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.