(148 days)
The RetroFix screw is a cannulated tapered screw intended to be used as stand-alone bone screw for internal bone fixation for bone fractures of the ankle.
The RetroFix screw is a cannulated tapered screw intended to be used as a stand-alone bone screw for internal bone fixation for bone fractures of the ankle. The screw shaft has a predetermined length with a cannula extending through the length of the shaft. The shaft has a relatively large outside diameter proximal segment, a smaller outside diameter threaded distal segment, and a flared end. The proximal segment and the distal segment are unitary. The cannula is adapted for use with a surgical K-wire. The screws have cortical threads and come in many different sizes, varying in diameter and lengths. The device does not come sterile and must be sterilized prior to use.
The provided text is a 510(k) summary for a medical device (RetroFix Bone Screw) seeking FDA clearance. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document primarily focuses on bench testing (mechanical strength) to establish substantial equivalence to a predicate device, which is a common pathway for traditional medical devices. There is no mention of an AI/ML component, clinical performance studies (other than noting There were no clinical tests performed for the RetroFix screw device), or any of the elements you've requested that are specific to AI/ML device validation (e.g., sample size for test sets, expert ground truth, MRMC studies).
Therefore, I cannot fulfill your request for the specific details related to AI/ML device acceptance criteria and study data based on the provided text.
The information you've asked for (acceptance criteria, test set details, expert qualifications, MRMC studies, standalone performance, ground truth establishment, training set details) are typically found in detailed clinical validation studies or specific performance reports for AI/ML medical devices, which are usually much more extensive than a 510(k) summary for a mechanical device.
In summary, the provided document does not contain the information necessary to answer your request regarding acceptance criteria and study data for an AI/ML device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.