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The EPI-Union Plating System is intended for use in the internal fixation of long bone fractures and long bone reconstruction.

The Epi-Union Plating System consists of a series of plates and screws for the internal fixation of long bone fractures and long bone reconstruction. The plates are available in different styles and configurations to fit various anatomical sites. Each plate has holes for screw fixation. The different styles of plates are precontoured to fit the anatomical profile of each specific site. The system includes tibial plates, fibular plates, calcaneal plates, humeral plates, and radial plates.

The system includes cancellous and cortical screws with head diameters of 6mm and 8mm. The screws are available in thread diameters ranging from 3.5mm to 6.5mm in varying lengths. Different styles include self-tapping, non-self-tapping, fully threaded, and partially threaded screw designs. The plates can also be used with standard cortical or cancellous bone screws that are commercially distributed.

The provided text describes a 510(k) premarket notification for a medical device called the "Epi-Union Plating System." This document is a regulatory approval, not a scientific study. Therefore, it does not contain information regarding acceptance criteria, device performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed. This typically involves comparing:

• Intended Use: The purpose for which the devices are used.
• Technological Characteristics: Design, materials, and operational principles.
• Performance Data: Often includes bench testing (mechanical, material, biocompatibility) to show that the new device performs as safely and effectively as the predicate, but usually does not involve clinical studies with human participants unless specifically requested by the FDA for novel aspects.

Given the content, I cannot fill in the requested table and study details as they are not present in this type of regulatory document.

Therefore, the response is:

This 510(k) summary does not contain the information required to describe the acceptance criteria and a study proving the device meets those criteria. The document is a regulatory approval demonstrating substantial equivalence to predicate devices, not a scientific study detailing performance metrics, sample sizes, ground truth establishment, or clinical effectiveness.

Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on equivalence, not specific performance metrics against defined criteria.
2. Sample sized used for the test set and the data provenance: Not present. No clinical or comparative performance study with a test set is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no mention of a test set with ground truth.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a plating system, not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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