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The Epic Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone of the hand, fingers and toes. The system may be used in both adult and pediatric patients. The plates/screws are intended for single use only.

The Epic Extremity Plate System consists of multiple plate families of various anatomical sizes and shapes, 2.7mm and 3.5mm locking and nonlocking screws which mate into the plates, as well as various instruments to assist in implanting the system.

This document describes the EPIC Extremity Plate System, a medical device, and its substantial equivalence to a predicate device, the DARCO Locking Bone Plate System (K061808). The information provided is from a 510(k) summary submitted to the FDA.

Acceptance Criteria and Device Performance:

The document does not explicitly state numerical acceptance criteria in a typical "performance metric target" format. Instead, the substantial equivalence determination for this metallic bone fixation appliance is based on comparability in intended use, indications for use, materials, construction, and performance characteristics to a legally marketed predicate device.

The "device performance" reported is the demonstration that the EPIC Extremity Plate System meets these comparability criteria through non-clinical testing.

Here's a table based on the provided text, representing the implicit acceptance criteria and the device's reported performance:

Detailed Study Information:

1. Sample sizes used for the test set and data provenance:

   • The document primarily references non-clinical performance data (mechanical testing standards ASTM F-543 and ASTM F-382). These tests involve material samples and constructed devices, not patient data.
   • Therefore, there is no human test set sample size mentioned.
   • Data provenance: Not applicable as it's non-clinical, mechanical testing.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable. Ground truth, in this context, would relate to the determination of mechanical properties and performance according to engineering standards. The expertise required would be in mechanical engineering and materials science for conducting and interpreting the ASTM tests, but no specific "expert consensus" for patient outcomes or diagnostic accuracy is relevant here.

3. Adjudication method for the test set:

   • Not applicable, as it's non-clinical, mechanical testing. There is no "adjudication" in the sense of reconciling human interpretations of clinical data.

4. 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:

   • No MRMC study was done. This device is a metallic bone fixation appliance, not an AI-powered diagnostic or assistive tool for human readers.
   • Effect size: Not applicable.

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

   • No standalone algorithm performance study was done. This is a hardware medical device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for this device's performance relies on established engineering standards and material properties as measured through ASTM F-543 and ASTM F-382 tests. These tests assess the mechanical strength, fatigue properties, and other relevant characteristics of bone fixation plates and screws. The results are compared against the known performance of the predicate device and generally accepted thresholds for such devices.

7. The sample size for the training set:

   • Not applicable. There is no training set for this device, as it is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set and therefore no ground truth to establish for it.

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