Search Results

Wright's EVOLVE® TRIAD™ Plating System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, radius and ulna.

The ORTHOLOC™ Mini polyaxial locking screws are intended for use with Wright's plates manufactured from implant grade stainless steel that accept ORTHOLOC™ Mini polyaxial locking screws.

The EVOLVE® TRIAD™ Bone 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, including the clavicle, scapula, long bones (ulna, radius and humerus) and small bones (metacarpals, metatarsals, and phalanges).

The EVOLVE® TRIAD™ Plating System consists of 9 plates, each belonging to 1 of 3 general categories-radial head, radial neck, and coronoid-based on the contouring of each plate. The radial head and radial neck plates feature poly-axial locking screw holes, the coronoid plates feature non-locking screw holes only.

All EVOLVE® TRIAD™ plates are made from Stainless Steel. The radial head and radial neck plates accept the 2.0mm ORTHOLOC™ Mini polyaxial locking screws and the 2.0mm EVOLVE® TRIAD™ non-locking bone screws. The coronoid plates accept the 2.0mm EVOLVE® TRIAD™ non-locking bone screws.

This document describes a 510(k) premarket notification for the "EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws". This is a medical device for bone fixation, and the application aims to demonstrate "substantial equivalence" to existing legally marketed predicate devices, rather than proving novel clinical effectiveness through new clinical trials. Therefore, the "study" referred to in the prompt is a non-clinical, comparative engineering study, not a clinical trial in the traditional sense of human subjects.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The document states the new device "can be expected to perform at least as well as" the predicate devices. Specific quantitative acceptance thresholds (e.g., minimum torque values, maximum displacement) are not provided in this summary, but would have been part of the detailed predicate comparison within the full Premarket Notification.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact number of plates or screws tested. It refers to "worst-case plate analysis" and "screw and construct" testing, which implies a representative sample was used for each test type.
• Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, Wright Medical Technology, Inc., located in Arlington, TN, USA. This is prospective testing performed specifically for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable for this type of device submission. The "ground truth" for demonstrating substantial equivalence of a bone fixation system is established through engineering principles and standardized mechanical testing as outlined by relevant ASTM or ISO standards, not expert clinical consensus on images or pathology. The "experts" involved would be the engineers and quality control personnel at Wright Medical Technology, Inc., who designed and conducted the tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results where human agreement is required to establish a "ground truth." For non-clinical bench testing, the results are objectively measured and compared against established engineering criteria or predicate device performance. The "adjudication" is inherent in the objective measurement and analysis of the mechanical tests performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is relevant for diagnostic imaging devices involving human interpretation. This submission is for an orthopedic implant and does not involve AI or human "readers" interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a passive orthopedic implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" is based on objective engineering measurements from mechanical bench tests (e.g., torque to failure, pull-out strength). These measurements are then compared against the performance of legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set, there is no ground truth to establish for one.

Ask a specific question about this device