(76 days)
The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.
General trauma screw for compression and fixation of bone. The purpose of this submission is to add MR Conditional information to the device labeling for K133842. The intended use and technological characteristics of the device remain unchanged.
The provided text describes a 510(k) premarket notification for the "Tyber Medical Trauma Screw." This document focuses on demonstrating substantial equivalence to a predicate device, specifically to add MR Conditional information to the device labeling.
Based on the information provided, this submission does not involve an AI/ML medical device, and therefore, it does not contain the information requested regarding acceptance criteria and studies for device performance in the context of AI/ML.
The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" sections, along with all the detailed points you requested (sample sizes, ground truth establishment, expert adjudication, MRMC studies, etc.), are relevant to AI/ML device submissions, particularly those involving diagnostic or prognostic algorithms that analyze medical images or data.
The provided document is for a traditional medical device (a trauma screw) and outlines non-clinical testing for MR safety and mechanical properties.
Here's why the requested information isn't present in this document:
- Type of Device: The device is a "Tyber Medical Trauma Screw," a physical bone fixation fastener. It's not an AI/ML algorithm.
- Purpose of Submission: The primary purpose of this 510(k) is to add "MR Conditional" information to the device labeling and to compare its mechanical performance (driving torque) to a predicate device.
- Testing Described: The document details non-clinical testing such as:
- MR Safety Testing (in accordance with ASTM 2503-13): Magnetically induced displacement force, magnetically induced torque, MR image artifact, and RF-induced heating.
- Mechanical Testing: Driving Torque per ASTM F543-17 Annex A2.
- Clinical Test Summary: Explicitly states "n/a" (not applicable), confirming no clinical studies were performed or required for this submission.
Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance, ground truth, expert opinions, or MRMC studies from the provided text.
§ 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.