(146 days)
The Ascension Ankle Fusion Plate System is intended for the following:
- Arthrodesis of the ankle joint and distal tibia
- Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.
The Ascension® Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a maior thread diameter of 4.5 or 6.5mm. All plates and screws will be manufactured from stainless steel or titanium.
This document describes a 510(k) premarket notification for a medical device, the Ascension® Ankle Fusion Plate System. It is focused on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing primary performance through a new clinical or non-clinical study against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as typically seen in performance studies for novel devices or AI algorithms, is not applicable in this context.
Here's why and what the document does provide:
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Acceptance Criteria and Reported Device Performance: Not applicable. The submission is based on substantial equivalence, meaning the new device is deemed safe and effective because it is essentially the same as a device already legally marketed. There are no performance metrics or acceptance criteria presented as there would be for a de novo device or a device requiring new clinical evidence.
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Sample Size used for the test set and data provenance: Not applicable. No new test set data was generated or analyzed for this 510(k) submission. The equivalence is based on comparison of design, materials, and intended use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment was used.
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Adjudication method for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 surgical implant (plate system), not an AI algorithm.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used: Not applicable.
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The sample size for the training set: Not applicable. This is not an AI algorithm.
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How the ground truth for the training set was established: Not applicable.
What the document does state regarding verification:
The document explicitly states: "Due to the similarity of materials and design to both pre-enactment and postenactment devices, it is believed that the Ankle Fusion Plate System does not raise any new safety or effectiveness issues and does not require any nonclinical testing. A comparison of dimensions/sizing addressing worst-case plates between the Ascension Ankle Fusion Plate System and the predicate devices was presented to support substantial equivalence."
This indicates that the "study" demonstrating the device meets the "acceptance criteria" (which in this case is substantial equivalence) involved a comparison of dimensions/sizing of the new device to existing predicate devices. However, the specific data from this comparison is not provided in this summary. The "acceptance criteria" for substantial equivalence are qualitative: "similar in design, materials and indications" and "does not raise any new safety or effectiveness issues." The "study" was a non-clinical engineering comparison of physical attributes to demonstrate these similarities, not a performance study against specified quantitative criteria.
§ 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.