Search Results

The Zimed Distal Medial Tibial Plate and Screw System is indicated for fixation of complex extra-articular and intraarticular distal medial tibial fractures and osteotomies.

Zimed Distal Medial Tibial Plate and Screw System is used for complex extra-articular and intraarticular distal tibial fractures, and osteotomies surgeries specifically designed for the anatomical alignment of the broken bones and to provide splinting with the ability to ensure the early mobility of the patient. Zimed plate and screw system is implantable device in long term contact with bones.

Zimed Distal Medial Tibial Plate and Screw System will be supplied non-sterile.

This document is a 510(k) premarket notification for the Zimed Distal Medial Tibial Plate and Screw System. It describes the device, its intended use, and provides a comparative analysis to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

This device is a metallic bone fixation appliance, not an AI/software device, therefore the typical acceptance criteria and study information for AI-driven solutions are not applicable. The information provided focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance testing to established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance:

The document describes performance testing on the device itself (physical plates and screws), not a clinical study involving patients or data. Therefore, terms like "test set," "sample size," and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since this is a physical device safety and performance evaluation rather than a diagnostic device, there are no "experts used to establish ground truth for the test set" in the way one would for an AI-driven image analysis tool. The "ground truth" is adherence to established engineering and material standards. This is determined through objective laboratory testing.

4. Adjudication Method for the Test Set:

Not applicable, as this is not a study involving human interpretation or subjective assessments that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance (with and without aid) is evaluated. This 510(k) is for a physical orthopedic implant.

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

Not applicable. This device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used:

The ground truth used is adherence to established engineering and material standards (ASTM F382, ASTM F136, ASTM F543) and compliance with relevant FDA guidance documents for orthopedic implant performance.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for a physical device, no ground truth needed to be established for it.

Ask a specific question about this device