The Emerge Medical Locking Mini Fragment System is intended for fixation of fractures, osteotomics, non-unions, deformations, revisions, replantations, of small bones and bone fragments including tarsals, metatarsals, carpals, metacarpals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.

The Emerge Medical Non-Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations of small bones and bone fragments including tarsals, metatarsals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.

The Emerge Medical Non-Locking Modular Hand System is intended for fixation of fractures, osteotomics, non-unions, deformations, replantations, of bones and bone fragments including phalanges, hand, and wrist, including in osteopenic bones.

The Emerge Medical Modular Foot System is intended for fixation of fractures, ostcotomics, non-unions, deformations, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle, including in osteopenic bone.

Device Description

The Emerge Medical Bone Plate System consists of stainless steel and titanium components including locking plates, cortex screws, cancellous screws, and washers. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The screws and plates are provided non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Emerge Medical Bone Plate System." This type of summary describes the device and its intended use, but does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found for software or AI-driven medical devices.

Instead, for implantable hardware like bone plates, the "study" referred to here is a series of non-clinical mechanical performance tests. The acceptance criteria for such devices are generally established by demonstrating "substantial equivalence" to predicate devices through these mechanical tests, rather than clinical performance metrics like sensitivity or specificity.

Therefore, many of the requested points are not applicable or cannot be answered from the provided text.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Mechanical Strength	Dynamic four-point bending (per ASTM F382-99)	Demonstrated strength sufficient for intended use and substantial equivalence to predicate devices.	Strength sufficient for its intended use and substantially equivalent to legally marketed predicate devices.
Mechanical Strength	Static torsion testing (per ASTM F543-13)	Demonstrated strength sufficient for intended use and substantial equivalence to predicate devices.	Strength sufficient for its intended use and substantially equivalent to legally marketed predicate devices.
Mechanical Strength	Static axial pullout (per ASTM F543-13)	Demonstrated strength sufficient for intended use and substantial equivalence to predicate devices.	Strength sufficient for its intended use and substantially equivalent to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance

Sample size: Not specified in the provided text. Mechanical tests typically use a certain number of samples, but the exact count is not disclosed here.
Data provenance: Not applicable in the context of device performance in a clinical setting. The tests are non-clinical, likely performed in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For mechanical testing of orthopaedic implants, "ground truth" is established by the engineering standards themselves (e.g., ASTM F382, ASTM F543) and the measured physical properties of the device, not by expert interpretation.

4. Adjudication method for the test set

Not Applicable. No adjudication method is described as the "test set" refers to mechanical test results against engineering standards.

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

No. This type of study is not relevant for a mechanical bone plate system. MRMC studies are typically for diagnostic or screening devices evaluated by human readers (e.g., radiologists) with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an algorithm or AI-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's performance is based on established engineering standards and physical measurements of mechanical properties. The "acceptance" is that these measurements demonstrate the device's strength is sufficient for its intended use and substantially equivalent to predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device; there is no "training set."

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" or corresponding ground truth for this mechanical device.

Summary

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5.510(K) SUMMARY

Submitter's Name:	Emerge Medical
Submitter's Address:	720 S. Colorado Blvd.Suite 550-SDenver, CO 80246
Submitter's Telephone:	(866) 553-0376
Submitter's Fax:	(800) 698-1440
Authorized Contact Name:	Michelle Potvin
Contact's Telephone:	720.459.6392
Contact's Email:	michelle.potvin@emergemedical.com
Date Summary wasPrepared:	November 15th, 2013
Trade or Proprietary Name:	Emerge Medical Bone Plate System
Common or Usual Name:	Single/multiple component metallic bone fixation appliancesand accessories (§888.3030)Smooth or threaded metallic bone fixation fastener(§888.3040)
Classification:	Class II per 21 CFR §888.3030Class II per 21 CFR §888.3040
Product Codes:	HRS, HWC
Classification Panel:	Orthopedic and Rehabilitation Devices Panel

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The device description for the Emerge Medical Bone Plate System is similar to that of the predicate devices listed in Table 5.1 Predicate Devices.

Technological Characteristics

The fundamental scientific principles and technological characteristics, including the intended use, material, general design, and sizes of the device are equivalent to the predicate device.

INDICATIONS FOR USE .

The indications for the Emerge Medical Bone Plate System are as follows for the four subsystems:

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The indications for use for the Emerge Medical Bone Plate 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
K030310	Synthes Modular Hand System	Synthes
K001941	Synthes Modular Foot System	Synthes
K020401	Synthes Calcaneal Plate	Synthes
K063049	Synthes Mini Fragment LCP System	Synthes
K011335	Synthes One-Third DCL Plate	Synthes
K010321	Synthes Modular Foot System-2.7mm Module	Synthes

Table 5.1 Predicate Devices

PERFORMANCE DATA

The Emerge Medical Bone Plate System has been tested in the following test modes:

Dynamic four-point bending per ASTM F382-99 (2008) �
. Static torsion testing per ASTM F543-13 (2013)
Static axial pullout per ASTM F543-13 (2013) .

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

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K133536 page 3 of 3

CONCLUSION

. I

The overall technology characteristics and mechanical performance data lead to the conclusion that the Emerge Medical Bone Plate System is substantially equivalent to the predicate device.

Emerge Medical Bone Plate System . (EC100009)

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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 features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

February 26, 2014

Emerge Medical Ms. Michelle Potvin Vice President of Quality Assurance 720 South Colorado Boulevard, Suite 550-S Denver, Colorado 80246

Re: K133536

Trade/Device Name: Emerge Medical Bone 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, HWC Dated: December 2, 2014 Received: December 4, 2014

Dear Ms. Potvin:

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 Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Michelle Potvin

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

Vincent J. Devlin -S

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

Enclosure

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K133536 ·

4. INDICATIONS FOR USE STATEMENT

Device Name: Emerge Medical Bone Plate System

The indications for the Emerge Medical Bone Plate System are as follows for the four subsystems:

The Emerge Medical Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of small bones and bone fragments including tarsals, metatarsals, carpals, metacarpals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.

The Emerge Medical Non-Locking Modular Hand System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including phalanges, hand, and wrist, including in osteopenic bones.

The Emerge Medical Modular Foot System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle, including in osteopenic bone.

Prescription Use	X
(Part 21 CFR 801 Subpart D)	AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth
Frank -S

Division of Orthopedic Devices

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.