(115 days)
Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods. Dolphix® External Fixation System MR Conditional is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries;
- Temporary stabilization of fractures in the context of polytrauma;
- Temporary stabilization of certain pelvic fractures or pelvic ring injuries;
- Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure:
- Temporary stabilization of non-unions;
- Intra-operative temporary stabilization tool to assist with indirect reduction.
Dolphix® External Fixation System MR Conditional is intended for use in a non-weight bearing patient.
Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods.
I am sorry, but based on the provided document, I cannot extract any information about acceptance criteria or a study proving device performance as the document primarily concerns an FDA 510(k) clearance letter for the "Dolphix® External Fixation System MR Conditional."
The letter outlines the regulatory classification, product codes, and indications for use of the device. It states that the device has been found substantially equivalent to legally marketed predicate devices, but it does not detail any specific performance studies or acceptance criteria beyond stating its intended uses.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts used for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.