(21 days)
StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.
StayFuse GT-IP has identical design features as the original StayFuse™, as such, GT-IP is a scalar version indicated for the IP joint of the great toe.
This submission describes a medical device, the StayFuse GT-IP, which is a scalar version of an existing device (StayFuse K990804) designed for the IP joint of the great toe. The 510(k) summary highlights that the new device has identical design features to the original, differing only in physical size. Therefore, the provided documents do not contain information related to a clinical study or performance data of the GT-IP requiring acceptance criteria.
The core of this 510(k) submission is a claim of substantial equivalence to a previously cleared device (StayFuse K990804). Substantial equivalence means that the new device has the same intended use as the predicate device, and the same technological characteristics, or, if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness.
Because the StayFuse GT-IP is described as having "identical design features as the original StayFuse™," and the only difference is "physical size" for use in a specific joint, a clinical study demonstrating performance against acceptance criteria for the new device is typically not required. The FDA's substantial equivalence determination for this device is based on the comparison to the predicate device, not on new clinical performance data for the GT-IP itself.
Therefore, the following information cannot be extracted from the provided text as it pertains to a performance study that was not conducted for this specific 510(k) submission:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
- Standalone (algorithm only) performance study
- 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.