(66 days)
The PhaLinx® Hammertoe System is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
The PhaLinx® Hammertoe System implants are a single piece titanium device offered in straight cannulated and 10° solid options. The implants have proximal and distal fixation features and are offered in multiple sizes.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) premarket notification for the PhaLinx Hammertoe System, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria.
Specifically, the text does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set, its data provenance, or the number/qualifications of experts for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set or how its ground truth was established.
The document only states that "Testing related to bending and pull-out strength were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system." and that "The safety and effectiveness of the PhaLinx® Hammertoe System is adequately supported by the mechanical testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification." This is a general statement about the type of testing performed, not a detailed report of study findings against specific acceptance criteria.
§ 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.