(84 days)
The Dyna Locking IM Nail™ is intended to be implanted into the intramedullary canal of femur or tibia for alignment, stabilization, fixation of fractures caused by trauma or disease:
- Proximal, middle and distal third femoral and tibial shaft fractures
- Severely comminuted, spiral and segmental fractures
- Nonunions and malunions
- Bone lengthening
The Dyna Locking IM Nail™ consists of three types of intramedullary rods (Femoral Nail, Tibial Nail, Unreamed Tibial Nail), Locking Screw, and Nail Cap. The rods are available in a variety of diameters and lengths and have holes located at the proximal and distal ends for fixation to bone by means of locking screws. An Nail Cap screws into the threaded end of the nails to prevent bone ingrowth, otherwise newbone in the nail hamper to remove the nail. All components of the Dyna Locking IM Nail™ are single use device, supplied nonsterile and manufactured from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM 136.
This 510(k) summary (K092771) describes a medical device, the "Dyna Locking IM Nail™", which is an intramedullary fixation system. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML performance.
This document is from 2009 and pertains to a physical medical device (intramedullary nail) used for orthopedic fracture fixation. The evaluation for this type of device typically involves:
- Bench testing: Mechanical tests to assess strength, fatigue life, and other physical properties.
- Biocompatibility testing: To ensure the material (titanium alloy) is safe for implantation.
- Sterilization validation: To confirm the non-sterile components can be safely sterilized.
- Comparison to predicate devices: Demonstrating substantial equivalence to devices already legally marketed, based on design, materials, and intended use.
The specific questions you've asked (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth for training set) are relevant to the evaluation of AI/ML-driven medical devices, which rely on analyzing data (images, signals, etc.). These questions are not applicable to the "Dyna Locking IM Nail™" as described in this 510(k) summary.
Therefore, I cannot provide the requested table and study details based on the provided text. The document is about a hardware medical device and not an AI/ML diagnostic or assistive device.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.