(84 days)
Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.
The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.
I am sorry, but the provided text from the FDA letter regarding the Vilex Bone Plate Systems does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device. This type of clearance focuses on equivalence rather than performance against specific acceptance criteria from a clinical study.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance.
- Sample sized used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.