(88 days)
The FastFrame External Fixation System - Ankle Spanning is indicated for use in treatment of distal tibia and foot fractures. Specifically, the system is intended for:
- Stabilization of open or closed fractures about the Ankle, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Arthrodesis and osteotomies with associated soft tissue problems about the ankle;
- Stabilization of limbs after removal of total ankle arthroplasty for infection or other failure;
- Stabilization of non-unions about the ankle; and
- Intraoperative temporary stabilization to assist with indirect reduction.
The purpose of this 510(k) is to obtain marketing clearance for the new device, the FastFrame External Fixation System - Ankle Spanning. The system consists of fixation half- pins and transfixing full-pins attached to rigid clamps connected by adjustable telescoping tubes (bars). The system is intended for use in the treatment of fractures about the ankle that require external fixation. The system also contains a separately sterile packaged FastFrame External Fixation System - Ankle Spanning Optional Clamp Assembly. This Optional Clamp Assembly is included as an optional accessory that allows the surgeon to hold the foot in a fixed position post- operatively, if desired.
The provided text describes a 510(k) premarket notification for the FastFrame™ External Fixation System - Ankle Spanning. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data. There is no information about acceptance criteria, a study proving the device meets acceptance criteria regarding AI/algorithm performance, or any MRMC/standalone studies as would be relevant for an AI/ML device.
The provided text only discusses the following regarding performance:
1. Acceptance Criteria and Device Performance (Mechanical Testing):
Since this is a mechanical fixation system, the acceptance criteria and performance are related to mechanical properties.
| Acceptance Criteria (Derived from text) | Reported Device Performance |
|---|---|
| Performance equivalent to predicate device in full construct rigidity | The mechanical testing confirmed that the subject devices perform substantially equivalent in full construct rigidity as compared to the predicate device. |
| Performance equivalent to predicate device in interconnection performance | The mechanical testing confirmed that the subject devices perform substantially equivalent in interconnection performance as compared to the predicate device. |
| FastFrame External Fixation System – Ankle Spanning Optional Clamp Assembly holds a clinically relevant load over a specified period of time. | The FastFrame External Fixation System – Ankle Spanning Optional Clamp Assembly was proven to be able to hold a clinically relevant load over a specified period of time. |
| MRI Conditional according to FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" | The FastFrame External Fixation System – Ankle Spanning and FastFrame External Fixation System – Ankle Spanning when used with the FastFrame External Fixation System -Ankle Spanning Optional Clamp Assembly were found to be MRI Conditional per FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on December 11, 2014. |
2. Sample size used for the test set and the data provenance:
The document states: "Non-Clinical Performance and Conclusions: • Performance Evaluation – The mechanical testing confirmed that the subject devices perform substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device."
There is no specific number provided for mechanical test "samples" or "test sets" in the context of materials/mechanical testing, nor is "data provenance" (like country of origin or retrospective/prospective nature) applicable to this type of non-clinical mechanical testing documentation.
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, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication is not relevant for mechanical testing.
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 device is a physical external fixation system, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this device, "ground truth" for non-clinical testing refers to established engineering specifications, mechanical testing standards, and direct measurements of properties like rigidity and load-bearing capacity.
8. The sample size for the training set:
Not applicable. There is no AI/ML training set for this device.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML training set for this device.
Summary of what is in the provided text:
The document is a 510(k) clearance letter for a medical device (external fixation system). The study proving the device meets acceptance criteria is described as non-clinical mechanical performance testing. This testing confirmed the device's substantial equivalence to a predicate device in terms of "full construct rigidity," "interconnection performance," and the ability of an optional clamp assembly to "hold a clinically relevant load over a specified period of time." Additionally, the device was found to be MRI Conditional.
Crucially, this document does not pertain to an AI/ML device, and therefore, questions related to AI acceptance criteria, training/test sets for algorithms, expert ground truth labeling, MRMC studies, or standalone algorithm performance are not addressed.
§ 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.