(269 days)
The Artemis Proximal Femoral Nail System is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Locking Screw, and Lag Screw) as well as non-sterile, reusable, Class I and II surgical instruments. The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).
The Artemis Nail is a cylindrical rod with a preassembled 4mm Set Screw, available in one size with a distal diameter of 11mm, a proximal diameter of 16.4mm, and a length of 180mm. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm.
This FDA 510(k) premarket notification describes the Artemis Proximal Femoral Nail System, an intramedullary fixation system. It confirms that clinical data was not needed for this device. The information provided heavily relies on comparisons to predicate devices and mechanical testing, rather than studies involving human participants or AI performance. Therefore, many of the requested details about acceptance criteria and study design are not applicable in this context.
Here's a breakdown of the available and unavailable information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Comparability | Subject device (Titanium alloy & CFR PEEK) demonstrated substantial equivalence to predicate (Titanium alloy) through performance characteristics. Reference device used to address material difference. |
| Static Bending of Construct Performance | Comparable to predicate devices. |
| Dynamic Bending of Construct Performance | Comparable to predicate devices. |
| Screw Torque to Failure Performance | Comparable to predicate devices. |
| Compliance with ISO 7206-4 | Successfully underwent testing. |
| Compliance with ASTM F1264 | Successfully underwent testing. |
| Compliance with ASTM F543 | Successfully underwent testing. |
| No new issues of safety or effectiveness | Demonstrated through comparison testing to the predicate. |
2. Sample size used for the test set and the data provenance
Not applicable. This device is an implantable medical device, and its performance was evaluated through mechanical testing, not clinical studies with human test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement accuracy, not expert human interpretation.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic or AI-assisted performance evaluation, not for mechanical testing of an orthopedic implant.
5. 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. This is not an AI-enabled device or a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-enabled device.
7. The type of ground truth used
For the safety and effectiveness assessment, the ground truth was based on:
- Mechanical Testing Standards: Adherence to established international and American standards such as ISO 7206-4, ASTM F1264, and ASTM F543.
- Predicate Device Performance: Performance data from legally marketed predicate devices served as a benchmark for comparison to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This document refers to the evaluation of a medical device (an intramedullary nail system), not an AI algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device evaluation.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.