(92 days)
The OIC FLEX-FIX™ System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.
The OIC FLEX-FIX™ System consists of a medial toggle body, UHMWPE suture tape and a lateral button assembled on a deployment handle, a 3.7mm drill bit, and a 3.5mm washer. The device is provided sterile. EO gas is used to sterilize the device.
The medial toggle body, lateral button and washer are manufactured from material that conforms to: ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Ally for Surgical Implant Applications (UNS R56401)
This document, K233531, is an FDA 510(k) clearance letter for a medical device called the OIC FLEX-FIX™ System, which is an orthopaedic implant for ankle fixation. The provided information focuses on the device's substantial equivalence to predicate devices and does NOT contain any data related to AI/ML software performance or an AI study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML, as no such study is described in this document.
The document discusses:
- The device's intended use for ankle syndesmosis and fractures.
- The device's components and materials.
- A comparison to predicate devices, noting similarities in intended use, operating principle, and design, and differences in material and toggle body dimensions.
- Performance testing: "Dynamic tensile testing and Static testing to failure was performed on the device and a predicate. The device was found to have acceptable mechanical characteristics for the intended uses." This refers to biomechanical testing of the physical implant, not a study of AI/ML software performance.
Therefore, I cannot fulfill your request for the following information based on the provided document:
- A table of acceptance criteria and the reported device performance (in the context of AI/ML).
- Sample size used for the test set and data provenance (for AI/ML).
- Number of experts used to establish ground truth and their qualifications (for AI/ML).
- Adjudication method (for AI/ML).
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done (for AI/ML).
- If a standalone (algorithm only) performance study was done (for AI/ML).
- The type of ground truth used (for AI/ML).
- The sample size for the training set (for AI/ML).
- How the ground truth for the training set was established (for AI/ML).
The document is solely about the clearance of a mechanical orthopaedic implant based on substantial equivalence to existing devices and standard mechanical testing.
§ 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.