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The EPIC Extremity Fusion Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet and ankles, including distal tibia. The plates/screws are intended for single use only.

The EPIC Extremity Fusion Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.5mm/5.5mm locking and non-locking screws that mate into the plates, 5.5mm fully and partial threaded cancellous, 5.5mm cannulated partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.

The EPIC Extremity Fusion Plate System is also designed to be used with various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).

The provided document is a 510(k) premarket notification for the EPIC Extremity Fusion Plate System. This document focuses on demonstrating substantial equivalence to predicate devices based on material, design, and performance characteristics, primarily through non-clinical testing and cross-sectional analysis.

It explicitly states:

• "No clinical testing was required." This means a clinical study, as typically described by the detailed questions you've asked regarding clinical acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, was not performed or required for this device's clearance.
• The entire document describes a medical device (bone fixation plates/screws), not an AI/ML-driven diagnostic or assistive software device that would typically involve a test set, ground truth experts, and MRMC studies.

Therefore, I cannot provide answers to the majority of your questions (1-9) because they pertain to a type of device and study not relevant or described in the provided text. The device in question is a physical implant, not a software algorithm requiring clinical performance evaluation against human readers or expert-established ground truth from medical images.

Summary of relevant information from the document (limited to what is present):

• Type of Device: Bone fixation plates and screws (physical implant).
• Study Type: Non-clinical performance data (cross-sectional analysis, bending strength testing in comparison to predicates).
• Ground Truth: Not applicable in the context of clinical expert review; mechanical properties were compared to predicate devices.
• Acceptance Criteria & Performance: The document states "Cross-sectional analysis demonstrated substantial equivalence." and "the addition of the EPIC Extremity Fusion Plates are substantially equivalent in bending strength to the predicate and does not introduce a new worse case into the system." This is the "acceptance" in a regulatory sense for this type of device. Specific quantitative criteria and detailed performance metrics are not given in this summary document, beyond the qualitative statement of substantial equivalence to predicates in bending strength.

Table of Acceptance Criteria and Reported Device Performance (based on the provided text's focus on substantial equivalence via non-clinical data):

Regarding your specific questions (1-9):

1. A table of acceptance criteria and the reported device performance: See table above, derived from the regulatory focus on substantial equivalence for this physical device. No clinical performance criteria are present.
2. Sample sizes used for the test set and the data provenance: Not applicable. This was non-clinical testing comparing to predicate devices, not a clinical trial with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was based on engineering analysis and comparison to predicate device specifications/performance, not expert medical opinion on images.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, explicitly states "No clinical testing was required."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
7. The type of ground truth used: For this device, the "ground truth" (or basis for comparison) was the established performance and characteristics of the predicate devices in non-clinical testing.
8. The sample size for the training set: Not applicable, as there is no machine learning component described.
9. How the ground truth for the training set was established: Not applicable.

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