The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.

Device Description

The Emerge Medical Distal Radius Set will include 6 and 9 locking hole head variations with pairs of locking and non-locking holes in the shafts to be used with a variety and screws to be FDA cleared and offered as a system of implants to be used for internal bone alignment and fixation of fractures of the radius. The system features plates with six and nine hole head variations with three and five hole shafts, 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).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Emerge Medical Distal Radius Set," a device intended for bone fixation. However, the document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving their fulfillment.

This type of submission (510(k)) typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those for novel devices or PMAs. The performance data presented is limited to non-clinical (FEA) testing.

Therefore, most of the requested information cannot be extracted from this specific document. Below is an attempt to answer what can be inferred from the provided text, and explicitly state what is missing.

Acceptance Criteria and Device Performance Study for the Emerge Medical Distal Radius Set

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Strength: Must be sufficient for intended use and substantially equivalent to legally marketed predicate devices.	Static and Dynamic Bending: Evaluated via Finite Element Analysis (FEA). Demonstrated that the predicate device (Synthes 2.4mm LCP Volar Column Distal Radius Plates K091644 and Synthes Locking Distal Radius Plating System K012114) was the "worst-case scenario." The results concluded that the strength of the Emerge Medical Distal Radius Set is sufficient for its intended use and substantially equivalent to predicate devices.
Material: Must be medical grade and equivalent to predicate devices.	Fabricated from medical grade stainless steel (ASTM F139-12). Similar to predicate systems.
Design, Sizes, Indications for Use: Must be similar to predicate systems without presenting new risks.	Has the same or similar design, sizes, and indications for use as predicate systems. Sizes differ slightly but present no new risks.
Biocompatibility/Safety (implied): No new risks due to materials or design.	Fabricated from medical grade stainless steel (ASTM F139-12). No new risks identified from slight size differences or similar design.

Missing Information:

Specific numerical acceptance criteria for static and dynamic bending (e.g., minimum load capacity, maximum deformation) are not provided in the document.
The exact numerical performance results (e.g., stress values, displacement) of the FEA for the Emerge Medical device or the predicate are not detailed. Only a qualitative "worst-case scenario" comparison and a conclusion of sufficiency are given.

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

Sample Size: Not applicable in the traditional sense of a clinical or human-subject test set. The performance evaluation was conducted using Finite Element Analysis (FEA), which is a computational method. It likely involved a digital model of the device.
Data Provenance: Not applicable. FEA is a simulation method.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This study involved non-clinical FEA and did not rely on expert ground truth establishment for a test set. Design and engineering expertise would have been involved in setting up and interpreting the FEA.

4. Adjudication Method for the Test Set

Not applicable. There was no human-reviewed test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. No MRMC comparative effectiveness study was conducted or mentioned. This device is a bone fixation appliance, not an imaging or diagnostic AI/ML device that would typically undergo such a study.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Yes, in spirit, but not an "algorithm" as typically conceived for AI/ML. The "standalone" performance here refers to the mechanical performance of the device itself, evaluated through FEA, without human interaction during the test. The FEA model computationally determined the device's mechanical characteristics.

7. Type of Ground Truth Used

Engineering Principles and Predicate Device Data. For the FEA, the "ground truth" for comparison and validation would typically involve:
- Established biomechanical engineering principles.
- Material properties of medical-grade stainless steel (ASTM F139-12).
- Potentially, existing mechanical performance data or design specifications of the predicate devices for comparative analysis, although this is not explicitly detailed. The statement that the predicate was the "worst-case scenario" implies a comparison to known performance characteristics, either simulated or from prior testing.

8. Sample Size for the Training Set

Not applicable. The performance evaluation was a non-clinical FEA, not an AI/ML algorithm that requires a training set. The FEA model itself is "designed" based on engineering specifications rather than "trained" on data.

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

Not applicable. There was no "training set" in the context of AI/ML. The FEA model's foundational data (material properties, geometry, boundary conditions) are established through engineering design, material science data, and biomechanical specifications.

Summary

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K140107 page 1 of 2

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 Distal Radius Set
Common or Usual Name:	Single/multiple component metallic bone fixation appliancesand accessories (§888.3030)
Classification:	Class II per 21 CFR §888.3030
Product Code:	HRS
Classification Panel:	Division of Orthopedic Devices

5.510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

TECHNOLOGICAL CHARACTERISTICS

The Emerge Medical Distal Radius Set 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 Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.

The Emerge Medical Distal Radius Set 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

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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.

The indication for use for the Emerge Medical Distal Radius Set is similar to that of the predicate devices listed in Table 5-2.

510kNumber	Trade or Proprietary or Model Name	Manufacturer
K091644	2.4mm LCP Volar Column Distal RadiusPlates	Synthes
K012114	Locking Distal Radius Plating System	Synthes

Table 5-2 Predicate Devices

PERFORMANCE DATA

Static and Dynamic Bending of the Emerge Medical Distal Radius Set 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 Distal Radius Set 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 Distal Radius Set is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings. The image is in black and white.

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

March 13, 2014

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

Re: K140107

Trade/Device Name: Emerge Medical Distal Radius Set 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: January 15, 2014 Received: January 15, 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 (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

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.hum.

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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4. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug AdministrationIndications for Use	Expiration Date: December 31, 2013See PRA Statement on last page.

510(k) Number (if known)	K140107
Device Name	Emerge Medical Distal Radius Set
Indications for Use (Describe)	The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.

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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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 L.Frank -S
Division of Orthopedic Devices

FORM FDA 3881 (9/13)	PSC Publishing Services (301) 443-8740 EF
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Emerge Medical Distal Radius Set

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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.