(104 days)
The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.
The PhantomTM Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.
The PhantomTM Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The PhantomTM nails are offered in a variety of lengths to accommodate variations in patient anatomy. The PhantomTM threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
This document is a 510(k) summary for the Phantom™ Small Bone Intramedullary Nail System, a medical device. It does not describe an AI/ML powered device, therefore the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly with respect to AI/ML specific aspects (like sample size for test/training set, expert ground truth, MRMC studies, standalone performance), is not present in the provided text.
However, I can extract information regarding the device's mechanical performance testing and its acceptance criteria as implied by the comparison to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria, but it describes the type of testing performed and the conclusion drawn from it. The acceptance is implied by the "substantially equivalent" determination.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate device | Worst-case Phantom™ nail: Static and dynamic bending performed according to ASTM F382. |
| Worst-case Phantom™ locking screw and threaded peg: Torsion, insertion/removal, and pullout performed according to ASTM F543. | |
| Conclusion: The mechanical test results and predicate comparisons demonstrated that the mechanical performance of the Small Bone Intramedullary Nail System is substantially equivalent to the predicate. This implies the device met the performance standards demonstrated by the predicate device for these tests. | |
| Similar technological characteristics to predicate device | The Phantom™ Small Bone Intramedullary Nail System possesses similar technological characteristics compared to the predicate device, including performance, basic design, material, manufacturing, and sizes/dimensions. The difference in stabilization method (combination nail/plate vs. plate) did not raise new questions of safety or effectiveness. |
Regarding the other requested information, the document does not contain:
- Sample size used for the test set and the data provenance: Not applicable as this is a mechanical device, not an AI/ML system tested on data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For mechanical testing, the "ground truth" is measured physical properties and performance under specific conditions as defined by ASTM standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary based on available information:
The study proving the device meets acceptance criteria was a series of mechanical tests on the worst-case configurations of the Phantom™ nail, locking screws, and threaded pegs. These tests were conducted according to ASTM F382 (for static and dynamic bending of the nail) and ASTM F543 (for torsion, insertion/removal, and pullout of the screws/pegs). The acceptance criteria were met by demonstrating substantial equivalence in mechanical performance and technological characteristics to the predicate device, the ParaLock Plating System™ (K140397). The document does not specify the exact number of units tested for mechanical properties, or the numerical thresholds for passing, but rather states that the comparison demonstrated substantial equivalence.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.