(269 days)
The HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures.
The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint.
The implantable K-wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-wires are indicated as guide pins for insertion of instruments and implants in the HammerTube™ System
The HammerTube™ System includes HammerTube™ and K-wire implants. the HammerTube™ is a commercially pure titanium plasma sprayed PEEK cylinder in varying diameters and lengths. The K-wires are stainless steel and double trocar pointed.
This document does not contain information about a study proving that a device meets specific acceptance criteria in the context of AI/ML performance.
The provided text is a 510(k) premarket notification letter from the FDA to Paragon 28 regarding their HammerTube System. It includes:
- Indications for Use: The HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges, mallet toe deformity, and revision hammertoe procedures. The K-wires are indicated for stabilization and fixation of small bones, as well as guide pins.
- Device Description: The HammerTube™ consists of a commercially pure titanium plasma-sprayed PEEK cylinder. The K-wires are made of stainless steel.
- Performance Data: "Static and dynamic cantilever bending, and static pullout testing was performed." This refers to mechanical testing of the physical device, not an AI/ML algorithm.
- Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices based on similar indications for use and technological characteristics (performance, basic design, material, and sizes).
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity for an algorithm), sample sizes, ground truth establishment, or expert reviews for an AI/ML device, as this document pertains to a physical medical device (HammerTube System) and its mechanical performance and substantial equivalence to predicates.
§ 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.