(71 days)
The cannulated screws may be used for fixation of long bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedure where other treatments or devices have failed, arthrodesis, and in conjunction with other fixation hardware). These cannulated screws are not to be used for spinal application or Carpal Tunnel Sydrome.
Various styles of stainless steel and titanium alloy cannulated screws. Screw diameters range from 3.5mm to 8.0mm and 6.5mm to 8.0mm, respectively.
The provided text describes a 510(k) premarket notification for cannulated screws and is a regulatory document, not a study evaluating the performance of an AI-powered medical device. It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of AI.
Therefore, I cannot answer the questions about:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done.
- Whether standalone performance was evaluated.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This document is about the regulatory clearance of a physical medical device (cannulated screws) based on substantial equivalence to existing devices, not about the performance evaluation of an AI algorithm.
§ 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.