(29 days)
The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.0mm (cannulated), Ø3.50mm (cannulated and non-cannulated) and Ø4.00mm (cannulated and non-cannulated) and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
The provided text is a 510(k) summary for the VECTOR™ Hammertoe Correction System. It describes the device, its indications for use, and its equivalence to predicate devices, primarily through engineering analysis. This document does not contain information about an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of AI/ML.
Therefore, I cannot fulfill your request for:
- 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
- MRMC comparative effectiveness study results
- Standalone (algorithm only) performance data
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states: "No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission: Engineering Analysis comparison of mechanical performance characteristics." This indicates that the safety and effectiveness were demonstrated through mechanical performance characteristics engineering analysis and comparison to predicates, not through clinical or AI/ML performance studies with human readers or AI algorithms.
§ 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.