The Emerge Medical Periarticular Locking Plate Set is intended for treatment of nonunions, mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions.

The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions.

The Emerge Medical Periarticular and Locking Large Fragment System is not intended for use with active or latent infection, osteoporosis, insufficient quantity or quality of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, patients who are unwilling or incapable of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Emerge Medical Periarticular and Locking Large Fragment System consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia and femur. The system features four (4) types of plates (4.5mm Locking Proximal Tibia Plate, 4.5 Locking Condylar Plate, Locking 4.5mm Narrow and Broad Plate, Locking T-Plate), bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.

AI/ML Overview

This document describes the regulatory submission for the Emerge Medical Periarticular and Locking Large Fragment System, primarily focusing on its substantial equivalence to predicate devices. It is not a study that evaluates a device's performance against detailed acceptance criteria in the context of an AI/human-in-the-loop system. Instead, it's a 510(k) premarket notification for a medical implant system based on mechanical testing and comparison to existing devices.

Therefore, many of the requested categories for AI/clinical study evaluation are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text, highlighting what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Static four-point bending	Sufficient strength for intended use and substantial equivalence to predicate devices (implied by FEA comparison)	"Strength of the ... System is sufficient for its intended use"
Dynamic four-point bending	Sufficient strength for intended use and substantial equivalence to predicate devices (implied by FEA comparison)	"Strength of the ... System is sufficient for its intended use"
Static screw pull-out	Sufficient strength for intended use and substantial equivalence to predicate devices (implied by FEA comparison)	"Strength of the ... System is sufficient for its intended use"
Static torsion	Sufficient strength for intended use and substantial equivalence to predicate devices (implied by FEA comparison)	"Strength of the ... System is sufficient for its intended use"
Overall Mechanical Performance	Substantial equivalence to legally marketed predicate devices	"Overall technology characteristics and mechanical performance data lead to the conclusion that the ... System is substantially equivalent to the predicate device."

Explanation of Acceptance Criteria: The acceptance criteria for this device, as presented in the document, are broadly defined as demonstrating "sufficient strength for its intended use" and, more importantly, "substantial equivalence to legally marketed predicate devices." The specific numerical thresholds or comparative tolerances are not explicitly stated in this text but would have been part of the underlying ASTM F382-99 and ASTM F543-13 standards and the FEA study.

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

This was a Finite Element Analysis (FEA) study, not a study with a "test set" of patient data.

Sample Size for Test Set: Not applicable in the context of human or imaging data. The "test set" refers to the worst-case plates and screws chosen for FEA simulation. The document mentions "worst-case plates and screws" but does not specify how many distinct FEA models or variations were run.
Data Provenance: Not applicable in the context of human data. The "data" comes from FEA simulations, which are computational models based on engineering principles and material properties.

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

Number of Experts: Not applicable. Ground truth for mechanical testing via FEA does not involve human expert consensus in the way clinical AI studies do. The "truth" is established by the validated engineering principles and material science used in the FEA models and the comparison to established ASTM standards and predicate device performance.
Qualifications of Experts: Not applicable for establishing ground truth in this context. The study was conducted by Emerge Medical and reviewed by the FDA's Division of Orthopedic Devices.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Mechanical testing and FEA results are objective measurements/simulations, not subject to human adjudication in the typical clinical study sense. Compliance with ASTM standards and comparison to predicate devices would be the "adjudication."

5. 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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission is for mechanical hardware, not an AI-assisted diagnostic or treatment planning tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: No, this is not an algorithm, so standalone performance is not applicable. The "performance data" is the mechanical strength of the physical device as simulated by FEA.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" for this engineering study is based on established mechanical engineering principles, material science (ASTM F139 medical grade stainless steel), and performance standards (ASTM F382-99, ASTM F543-13). The primary "truth" being established is the substantial equivalence to existing predicate devices already approved for market, implying their safety and effectiveness.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no "training set" in the context of an engineering analysis of a physical implant. The FEA models are built based on the device design and material properties.

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

How Ground Truth for Training Set Was Established: Not applicable. There is no "training set" or "ground truth" in the AI/clinical sense. The "ground truth" for the FEA models themselves would be the physical properties of the materials and the validated equations/algorithms within the FEA software.

Summary

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MAR 1 Z 2014

K140119 page 1 of 3

Submitter:	Emerge Medical
Submitter's Name:	Michelle Potvin, Vice President of Quality Assurancemichelle.potvin@emergemedical.com
Submitter's Address:	720 S. Colorado Blvd.Suite 550-SDenver, CO 80246
Submitter's Telephone:	720.459.6392
Submitter's Fax:	(800) 698-1440
Contact Person:	Meredith L. May MS, RAC719.337.7579MMay@EmpiricalTesting.com
Date Summary was Prepared:	15 January 2014
Trade or Proprietary Name:	Emerge Medical Periarticular and Locking Large FragmentSystem
Common or Usual Name:	Single/multiple component metallic bone fixationappliances and accessories (§888.3030), Smooth orthreaded metallic bone fixation fastener (§888.3040)
Classification:	Class II per 21 CFR §888.3030 and §888.3040
Product Code:	HRS and HWC
Classification Panel:	Division of Orthopedic Devices

5.510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

TECHNOLOGICAL CHARACTERISTICS

The Emerge Medical Periarticular and Locking Large Fragment System has the same or similar design, sizes, indications for use, and materials as the predicate systems. The sizes differ slightly, but present no new risks.

INDICATIONS FOR USE

The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems:

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The indication for use for the Emerge Medical Periarticular and Locking Large Fragment System is similar to that of the predicate devices listed in Table 5-1 Predicate Devices.

510k Number	Trade or Proprietary or Model Name	Manufacturer
K082807	3.5mm and 4.5mm Locking Compression Plate (LCP)System with Expanded Indications	Synthes
K000682, K041911	Locking Fragment Dynamic Compression Locking (DCL)System, LCP Curved Plates	Synthes
K000066	Locking Condylar Plate (LCP) System	Synthes
K110354, K083025	4.5mm VA-LCP Curved Condylar Plate System	Synthes
K062564	LCP Distal Femur Plate	Synthes
K010766	Large Fragment Locking Compression Plate (LCP) System- T Plate	Synthes
K011978, K002361,K983787	LCP Proximal Tibia Plate, Locking Proximal Tibia Plating(L-PTP) System, Proximal Tibia Plating System	Synthes

Table 5-1 Predicate Devices

PERFORMANCE DATA

The Emerge Medical Periarticular and Locking Large Fragment System were evaluated via finite element analysis (FEA) demonstrative the predicate was the worst case scenario. The folloing test modes were emulated on the worst-case plates and screws through FEA:

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Static four-point bending per ASTM F382-99 .
Dynamic four-point bending per ASTM F382-99 .
Static screw pull-out per ASTM F543-13 .
Static torsion per ASTM F543-13 .

The results of this non-clinical testing show that the strength of the Emerge Medical Periarticular and Locking Large Fragment System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Emerge Medical Periarticular and Locking Large Fragment System is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

March 12, 2014

Emerge Medical %.Ms. Meredith May MS. RAC Senior Manager Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K140119

Trade/Device Name: Emerge Medical Periarticular and Locking Large Fragment 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, HWC Dated: January 15, 2014 Received: January 16, 2014

Dear Ms. May:

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

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Page 2 - Ms. Meredith May

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

hup://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html 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/Safetv/RcportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Lori A. Wiggins

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

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K140119

4. INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: December 31, 2013See PRA Statement on last page.
Indications for Use
510(k) Number (if known)	K140119
Device Name	Emerge Medical Periarticular and Locking Large Fragment System
Indications for Use (Describe)
The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems:
The Emerge Medical Periarticular Locking Plate Set is intended for treatment of nonunions, mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures, fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions.
The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth LFB/ank -S
Division of Orthopedic Devices
FORM FDA 3881 (9/13)	PBC Publishing Bervices (301) 443-8740 EF

Emerge Medical Periarticular and Locking Large Fragment System

・

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.