(107 days)
The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The implants of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial F MTP) contain implants and instruments or instruments only provided sterile by gamma sterilization.
This document is a 510(k) premarket notification for the Footmotion Plating System. As such, it does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML performance evaluation. This device is a medical implant system, not a software or AI-driven diagnostic tool.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of submission. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical safety, rather than evaluating performance against a specific clinical metric.
Here's a breakdown of the information that is applicable or discernible from the provided text, along with an explanation for why other points are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present acceptance criteria for performance in the typical sense of accuracy, sensitivity, or specificity that would apply to an AI/ML device. Instead, "acceptance criteria" are implied through the demonstration of substantial equivalence to legally marketed predicate devices. The performance is assessed through engineering analyses and material testing to ensure the device is safe and effective for its intended use, similar to its predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Similar to predicate devices. | "The Footmotion Plating System is substantially equivalent to the predicate devices in terms of intended use..." |
| "The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults." (Matches predicate's likely intended use implicitly) | |
| Design: Similar to predicate devices. | "The Footmotion Plating System is substantially equivalent to the predicate devices in terms of... design..." |
| "The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults." (Implies design is appropriate for stated use and therefore comparable to predicates) | |
| Materials: Biocompatible and mechanically suitable. | "Titanium alloy Ti-6Al-4V (conform to ASTM F136 and ISO 5832-3)." (Demonstrates use of a known, biocompatible, and mechanically sound material, equivalent to predicates.) |
| Mechanical Safety/Performance: Equivalent to predicate devices. | "Engineering analyses have been conducted in comparison with the predicate devices." (Implied acceptance is that these analyses demonstrate comparable mechanical performance and safety to predicates.) |
| Biocompatibility/Sterility: Meets relevant standards. | "LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of |
§ 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.