(279 days)
The Tornier Ankle Arthrodesis Plate System is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, and fusions of small bones including the foot and ankle.
The Tornier Ankle Arthrodesis Plate System consists of minimally contoured plates, screws and washers. Reusable instruments are provided to facilitate fixation in total ankle arthrodesis and fracture fixation, fusion, and osteotomy of the bones of the foot. The Ankle Arthrodesis Plate System is made of stainless steel material or titanium material.
The Tornier Ankle Arthrodesis Plate System plates are not differentiated for Right or Left sides. The system includes an Anterior Tibio-Talar Plate (two sizes, plus an optional augmentation plate), a Lateral Tibio-Talar Plate (three sizes), and a Lateral Tibio-Talar-Calcaneal Plate (three sizes). The screws are provided in one diameter and in various lengths. The washers are provided in one size.
The system consists of sheaths that are attached to the bone plate by screws to cover the bone screws in bone plates. The osteosynthesis screws are driven into the bone through holes in the plates.
This document is a 510(k) summary for the Tornier Ankle Arthrodesis Plate System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a specific study. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not present in this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Not Provided. The document does not describe specific performance-based acceptance criteria for the Tornier Ankle Arthrodesis Plate System, nor does it provide reported device performance metrics against such criteria. The entire 510(k) submission is about demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This means the device is considered safe and effective if it has the same intended use as a predicate device and its technological characteristics do not raise different questions of safety and effectiveness, or if it has different technological characteristics, but the information submitted demonstrates that the device is as safe and effective as a legally marketed predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. This document does not describe any clinical or performance studies with a test set of human subjects or data. The evidence for substantial equivalence primarily relies on a comparison of device characteristics (design, materials, intended use, mechanical testing) to predicate devices. There's no mention of sample sizes, data provenance, or study design (retrospective/prospective) because this isn't a clinical trial report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided. As no clinical or data-driven test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. No test set is described.
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/Not Provided. This is not an AI-enabled device. Therefore, no MRMC comparative effectiveness study or AI-related performance is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided. This is not an AI-enabled device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided. No ground truth data is discussed in the context of device performance testing in this summary. The "ground truth" for a 510(k) is usually the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable/Not Provided. This is not an AI-enabled device or a device developed through data-driven training.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. This is not an AI-enabled device or a device developed through data-driven training.
Summary of the Study/Evidence Provided in the Document:
The "study" presented in this 510(k) summary is a substantial equivalence comparison to legally marketed predicate devices.
- Device: Tornier Ankle Arthrodesis Plate System
- Predicate Devices:
- Methodology for Demonstrating Substantial Equivalence:
- Identical Intended Use: The Tornier system's intended use ("arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, and fusions of small bones including the foot and ankle") is stated to be substantially equivalent to the predicates.
- Similar Technological Characteristics: The document describes the Tornier system's components (minimally contoured plates, screws, washers made of stainless steel or titanium), design (not differentiated for right/left sides, specific plate types), and function (fixation). It then asserts that these characteristics do not raise new issues of safety or effectiveness compared to the predicates.
- Performance Data: While not detailed in this summary, a full 510(k) submission would typically include bench testing (e.g., mechanical strength, fatigue testing) to ensure the new device performs comparably to the predicate or meets recognized standards relevant to its intended use. This summary implies that such data supports substantial equivalence, stating, "The Tornier Ankle Arthrodesis Plate System does not raise any new issues of scientific technology, safety or effectiveness."
Conclusion:
This 510(k) summary (K090139) is a regulatory document focused on demonstrating substantial equivalence to predicate devices, not on providing performance metrics against specific acceptance criteria from a clinical or AI-based study. The FDA's letter confirms their agreement that the device is substantially equivalent for the stated indications for use.
§ 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.