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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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The EPIC Extremity Fracture Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.

The EPIC Extremity Fracture Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.0mm locking and non-locking screws that mate into the plates, 4.0mm fully and partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.

The EPIC Extremity Fracture Plate System is also designed to accept the 2.7mm/3.5mm locking/non-locking screws and various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).

Based on the provided text, the document is a 510(k) premarket notification for the "EPIC Extremity Fracture Plate System." This submission is for a medical device (bone fixation plates and screws), not an AI/Software as a Medical Device (SaMD). Therefore, the acceptance criteria and study design elements typically associated with AI/SaMD (such as performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The document explicitly states:

• "No clinical testing was required." This means there was no human clinical study conducted for this device.
• The non-clinical performance data summarized refers to "ASTM F-543," which is a standard specification for metallic medical bone screws. This concerns the mechanical properties and performance of the physical screws, not an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets those criteria using the provided text. The provided document concerns a physical orthopedic implant, not a software-based medical device that would involve AI performance metrics.

In summary, none of the requested information regarding AI/SaMD acceptance criteria and study details can be extracted from this document, as it is irrelevant to the type of device being discussed.

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The EPIC Extremity Snap-Off Screw is indicated for use in fixation of bone fractures or bone reconstruction.

Examples include:

*Fixation of small bone fragments

• Weil osteotomy

*Mono-cortical fixation

*Osteotomies and fracture fixation in the foot and hand

The Snap-Off Screw is intended for single use only.

The EPIC Extremity Snap-Off Screw will consist of headed snap off screws of various lengths and instruments to assist in implanting the devices.

The provided text is related to a 510(k) premarket notification for a medical device (EPIC Extremity Snap-Off Screw). It is a regulatory document from the FDA detailing the approval of a medical device based on its substantial equivalence to previously marketed predicate devices.

However, the document DOES NOT contain information regarding a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device, nor does it provide details on human reader studies, ground truth establishment, or sample sizes related to AI model validation.

The document states:

• "No clinical testing was required."
• The non-clinical performance data summary explicitly lists tests related to the mechanical properties of a screw (e.g., ASTM F-543, Torsional Properties, Axial PullOut, Torque to Fail: Snap-Off Feature). These are physical engineering tests for a hardware device, not performance metrics for an AI/ML system.

Therefore, I cannot fulfill the request as the provided text doesn't contain the necessary information about an AI/ML device study. The questions are specifically framed for the validation of an AI/ML-driven device, which is not what this document describes.

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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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The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.

Screws are intended for single use only.

The Epic Extremity Cannulated Screw System will consist of multiple diameter headed and headless cannulated screws of various lengths and instruments to assist in implanting the system.

This document is a 510(k) summary for the Epic Extremity Cannulated Screw System, which is a medical device. As such, it does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML model's performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

1. Intended use and indications for use, which are similar to the predicate devices.
2. Technological characteristics, specifically that the device is manufactured from the same material (Ti-6Al-4V per ASTM F-136) and has a similar range of sizes as the predicate devices.
3. Non-clinical performance data, referencing ASTM F-543.
4. No clinical performance data was required for this 510(k) submission.

Therefore, I cannot provide the requested information. The document explicitly states: "No clinical testing was required," and "No clinical performance data was done."

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