(92 days)
A trauma screw designed to apply compression and fixation between two adjacent segments of cortical and/or calcaneus bone.
The Tyber Medical Trauma Screws are 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 sterile and non-sterile implants come solid and cannulated, titanium and stainless steel.
This document describes K133842 for the Tyber Medical Trauma Screw.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Set by ASTM F544) | Reported Device Performance (Tyber Medical Trauma Screw) |
|---|---|
| Pullout strength as per ASTM F544 | All data indicates the device is substantially equivalent to the predicate systems |
| Torsional Yield as per ASTM F544 | All data indicates the device is substantially equivalent to the predicate systems |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" and instead refers to non-clinical mechanical testing. The sample size for this mechanical testing is not explicitly stated. The data provenance is non-clinical, meaning it originates from laboratory testing. No information is provided regarding country of origin or whether it's retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a mechanical implant, and its performance is evaluated through objective mechanical tests (Pullout and Torsional Yield) rather than relying on expert-established ground truth like in image-based diagnostic devices.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods are typically used when subjective assessments or multiple reader interpretations are involved, which is not the case for mechanical testing of a bone screw.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device (bone screw), not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the form of non-clinical mechanical testing. The study evaluated the Tyber Medical Trauma Screw's Pullout and Torsional Yield strength. The results indicated substantial equivalence to predicate devices.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by the standardized requirements and testing methods defined in ASTM F544 for pullout and torsional yield strength. The performance is assessed against these established mechanical properties.
8. Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It's a physical medical device.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this 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.