(77 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 size of 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 K153575. The intended use and technological characteristics of the device remain unchanged.
This document describes the 510(k) premarket notification for the Tyber Medical Trauma Screw (K192975). This submission's primary purpose is to add MR Conditional information to the device labeling for a previously cleared device (K153575). Therefore, the study described focuses on demonstrating the device's safety in an MRI environment, rather than its general clinical effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM Standards) | Reported Device Performance |
|---|---|
| Magnetic Resonance (MR) Safety (ASTM 2503-13 general requirement) | Demonstrated conditional safety of Tyber Medical Trauma Screw in the MR environment under specific MR conditions of use. |
| Magnetically induced displacement force (ASTM F2052-15) | Tests performed, results indicate conditional safety. (Specific performance values are not provided in this summary, only that testing was done and supports conditional safety.) |
| Magnetically induced torque (ASTM F2213-17) | Tests performed, results indicate conditional safety. |
| MR image artifact (ASTM F2119-07) | Tests performed, results indicate conditional safety. |
| RF-induced heating (ASTM F2182-11a) | Tests performed, results indicate conditional safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of devices tested for each non-clinical evaluation. It generally refers to "the Tyber Medical Trauma Screw" being exposed to the MR environment.
- Data Provenance: The data provenance is from non-clinical testing (bench testing) performed to evaluate the MRI safety of the device. There is no information about the country of origin, but it can be assumed to be conducted by or for Tyber Medical LLC, based in Bethlehem, Pennsylvania, USA. The study is prospective in nature, as it involves active testing to generate new safety data for the device in the MR environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable as the evaluations were non-clinical (bench testing) focusing on physical properties and interactions with an MRI scanner. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The ground truth was based on adherence to the specified ASTM testing standards and objective measurements.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluations were non-clinical (bench testing). Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (trauma screw) and its MRI compatibility, not an AI-powered diagnostic tool. The document states "Clinical Test Summary: n/a".
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this study was established by objective measurements and adherence to international recognized ASTM standards for MRI safety testing. These standards define the parameters and methods for evaluating magnetic field interactions, torque, heating, and artifact generation.
8. The Sample Size for the Training Set
- This information is not applicable. There was no "training set" as this was non-clinical bench testing of a physical device, not an AI model requiring training data.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable as there was no training set.
§ 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.