(21 days)
This device is used in the general management of fractures and reconstructive surgery.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Helical Compression Anchor System, Cannulated, Version 2." It primarily states that the device has been found substantially equivalent to a legally marketed predicate device for the stated indications for use.
The document does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or types of studies conducted (e.g., test set, ground truth experts, adjudication methods, MRMC studies, standalone performance).
- Information on the training set or how its ground truth was established.
The "Indications for Use Statement" only provides the general purpose of the device: "This device is used in the general management of fractures and reconstructive surgery." This is an intended use statement, not a list of performance acceptance criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.