(28 days)
The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
The current submission is for minor design modifications to the components that make up the tibia and fibula anchors and corresponding changes to some of the tools used to install them.
This document is a 510(k) premarket notification for the Akros FibuLink™ Syndesmosis Repair Kit. It describes the device, its intended use, and a summary of non-clinical testing conducted. However, it explicitly states that clinical testing was not necessary to demonstrate substantial equivalence to the predicate device.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies cannot be provided from the given text.
The information that can be extracted relates to the non-clinical testing performed to establish equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a qualitative statement about the outcomes.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Lateral pull-to-failure | Adequate strength for intended use; comparable to predicate device | "The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use." |
| Offset load-to-failure | Adequate strength for intended use; comparable to predicate device | "The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use." |
| Insertion torque | Appropriate torque for bone insertion | "The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use." |
| Torque-to-failure | Adequate resistance to failure; comparable to predicate device | "The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use." |
| Fatigue with pull-to-failure | Adequate durability for intended use; comparable to predicate device | "The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use." |
Note: The phrase "adequate for its intended use" implies that the results met internal specifications or were comparable to the predicate device, which functioned as the de facto "acceptance criteria" for demonstrating substantial equivalence through non-clinical testing.
The following questions cannot be answered from the provided text as the application explicitly states that clinical testing was not necessary.
- Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set mentioned.
- Adjudication method for the test set: Not applicable; no clinical test set mentioned.
- 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 medical device, not an AI/software product, and no clinical studies were performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is a physical medical device.
- The type of ground truth used: Not applicable; no clinical ground truth was established as no clinical testing was performed.
- The sample size for the training set: Not applicable; this device is a physical medical device, not an AI/software product, and no training set was used in the context of an algorithm.
- How the ground truth for the training set was established: Not applicable; no training set or ground truth in the context of a study was established.
§ 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.