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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criteria (Implicit)	Reported Device Performance
Same Intended Use as predicate device	The EPIC Extremity Plate System has the same intended use.
Similar Indications for Use as predicate device	The EPIC Extremity Plate System has similar indications for use.
Manufactured from similar materials as predicate device	The EPIC Extremity Plate System is manufactured from similar materials.
Similar range of sizes as predicate device	The range of sizes of the EPIC Extremity Plate System are similar.
Comparable performance characteristics through non-clinical tests	Substantial equivalence in performance characteristics demonstrated via ASTM F-543 and ASTM F-382 testing.

Detailed Study Information:

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.
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.
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.
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.
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.
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.
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.
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2016

EPIC Extremity, LLC % Mr. Lee Strnad President Intrepid Orthopedics, LLC 3046 Brecksville Road. Suite 4 Richfield, Ohio 44286

Re: K153340 Trade/Device Name: Epic Extremity Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 20, 2015 Received: November 23, 2015

Dear Mr. Strnad:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153340

Device Name EPIC Extremity Plate System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the text "K153340 Page 1 of 2" at the top. Below that is the word "EPIC" in large, bold, black letters. Underneath "EPIC" is the word "EXTREMITY" in smaller letters. The word "EXTREMITY" is in a gradient of blue and white.

Epic Extremity Plate System 510(k) Summary

Submitter Information

Applicant:	EPIC Extremity, LLC120 Marquerite Dr., Ste 301Cranberry Twp., PA 16066
Contact Person:	Lee A. StrnadManagement RepresentativeIntrepid Orthopedics3046 Brecksville Rd, Ste 4Richfield, OH 44286(330) 659-0855
Date Prepared:	November 10, 2015
Name of Device:	Epic Extremity Plate System
Common Name:	Bone Fixation Plate
Classification Name	Single/Multiple component metallic bone fixation appliancesand accessories (per 21 CFR 888.3030)
Product Code/Panel:	HRS/Orthopedics
Predicate Devices:	DARCO Locking Bone Plate System (K061808).

Intended Use:

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

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for Epic Extremity. The logo is in black and white, with the word "EPIC" in large, bold letters. Below the word "EPIC" is the word "EXTREMITY" in smaller letters. At the top of the image, the text "K153340 Page 2 of 2" is visible.

Epic Extremity Plate System 510(k) Summary

Technological Characteristics

The EPIC Extremity Plate System have the same intended use as the predicate devices. The EPIC Extremity Plate System have similar indications for use as the predicate devices. The EPIC Extremity Plate System is manufactured from similar materials as the predicate devices. The range of sizes of the EPIC Extremity Plate System are similar to the predicate devices.

Non-Clinical Performance Data Summary

ASTM F-543 2. ASTM F-382

Clinical Performance Data Summary

No clinical testing was required.

Non-Clinical and Clinical Performance Data Conclusions

Based on testing results and the comparisons provided, the EPIC Extremity Plate System are considered substantially equivalent to the Darco Locking Bone Plate System in material, construction, and performance characteristics.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.