The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Emerge Medical Small Fragment Locked Plating System Line Extension is not intended for use with active or latent infection, osteoporosis, insufficient quantity of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, and 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 Small Fragment Locked Plating System Line Extension consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia. The system features a single plate design, 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 F139-12), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, specifically focusing on what is not present in the document for AI/software-based devices:

It's important to note that the provided document describes a physical medical device (a bone fixation system), not an AI/software-based device. Therefore, many of the typical criteria and study types associated with AI device validation (like expert consensus, radiologists, MRMC studies, training/test sets, ground truth establishment) are not applicable and are consequently absent from this submission.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this type of medical device (a substantial equivalence determination for a 510(k) submission) is demonstrating that it is as safe and effective as a legally marketed predicate device. This is primarily achieved through showing similar technological characteristics and equivalent performance.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance
Technological Characteristics	The Emerge Medical Small Fragment Locked Plating System Line Extension has the same or similar design, sizes, indications for use, and materials as the predicate systems. Sizes differ slightly but present no new risks.
Indications For Use (IFU)	The IFU for the Emerge Medical Small Fragment Locked Plating System Line Extension is similar to that of the predicate devices. (Specific IFUs are listed for distal and proximal tibia fractures).
Mechanical Performance (Strength & Durability)	Static and Dynamic Bending of the Emerge Medical Small Fragment Locked Plating System Line were evaluated via finite element analysis (FEA). The results demonstrated that the predicate device represented the "worst case scenario," implying the subject device performs at least as well.
Safety & Effectiveness	The overall technology characteristics and mechanical performance analysis lead to the conclusion that the device is substantially equivalent to the predicate device, implying equivalent safety and effectiveness for its intended use.

Study Details (Relevant to Physical Device Validation - Not AI/Software)

As this is not an AI/software device, the questions related to AI-specific validation (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication, MRMC, standalone performance, type of ground truth) are not directly applicable.

Instead, the study conducted for this device is a non-clinical performance evaluation:

Sample size used for the test set and the data provenance: Not applicable in the context of an AI device. For this physical device, the evaluation was primarily through finite element analysis (FEA), which is a computational modeling technique. There isn't a "test set" in the sense of patient data. The "data provenance" would refer to the engineering and materials specifications used in the FEA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is established through engineering standards, material science, and computational modeling principles, not clinical expert consensus on patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is not an AI-assisted diagnostic or prognostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" for evaluating performance would be engineering and biomechanical principles, material properties (ASTM F139-12 for stainless steel), and comparison to established predicate device performance. The FEA would be validated against these physical principles and potentially prior physical testing data for similar devices to ensure its accuracy.
The sample size for the training set: Not applicable for a physical device validated via FEA.
How the ground truth for the training set was established: Not applicable.

Summary for AI-Specific Questions (based on device type):

1. Sample sized used for the test set and the data provenance: Not applicable. The "study" was Finite Element Analysis (FEA) of the device's mechanical properties.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, not done. This is a physical bone fixation device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not done. This is a physical bone fixation device.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Engineering and biomechanical principles, material properties, and performance data from predicate devices.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the document describes a 510(k) submission for a physical medical device (bone plating system) and its validation through non-clinical mechanical testing (Finite Element Analysis) against predicate devices. The acceptance criteria revolve around substantial equivalence in design, materials, indications for use, and mechanical performance to legally marketed predicate devices. The validation methods are appropriate for a physical implantable device, but fundamentally different from those required for AI/software-based devices.

Summary

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5.510(K) SUMMARY

Table 5-1 Summary Table

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 Small Fragment Locked Plating System
Common or Usual Name:	Single/multiple component metallic bone fixation appliances andaccessories (§888.3030), Smooth or threaded metallic bonefixation 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

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

TECHNOLOGICAL CHARACTERISTICS

The Emerge Medical Small Fragment Locked Plating System Line Extension 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 Small Fragment Locked Plating System are as follows for the two subsystems:

Emerge Medical Small Fragment Locked Plating System Line Extension

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The indication for use for the Emerge Medical Small Fragment Locked Plating System Line Extension is similar to that of the predicate devices listed in Table 5-2.

510k	Trade or Proprietary or Model	Manufacturer
Number	Name
K983787	Proximal Tibia Plating System	Synthes
K002361	Locking Proximal Tibia Plating(L-PTP) System	Synthes
K011978	LCP Proximal Tibia Plate	Synthes
K001945	Medial Distal Tibia Plates	Synthes

Table 5-2 Predicate Devices

PERFORMANCE DATA

Static and Dynamic Bending of the Emerge Medical Small Fragment Locked Plating System Line were evaluated via finite element analysis (FEA) demonstrating the predicate device was the worst case scenario. The results of this non-clinical testing show that the strength of the Emerge Medical Small Fragment Locked Plating System Line Extension is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance analysis lead to the conclusion that the Emerge Medical Small Fragment Locked Plating System Line Extension is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 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: K140098

Trade/Device Name: Emerge Medical Small Fragment Locked Plating 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 14, 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 10 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 Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Meredith May MS, RAC

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 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 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. Wigqins

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

Enclosure

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K140098 page 1 of 1

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)	K140098
Device Name	Emerge Medical Small Fragment Locked Plating System
Indications for Use (Describe)
The indications for the Emerge Medical Small Fragment Locked Plating System are as follows for the two subsystems:
The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
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 Frank -S
Division of Orthopedic Devices
FORM FDA 3881 (9/13)	PSC Publishing Services (301) 443-6740 EF

Emerge Medical Small Fragment Locked Plating System Line Extension

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.