The Merete Locking Bone Plate System III can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

Device Description

The Merete Locking Bone Plate System III consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for the fixation with Merete 3.0 and 3.5 mm locking screws and 3.0 mm cannulated compression screws. Before placing the screws, plates can be fixed temporarily with K-Wires. Plates, screws and K-Wires of the Merete Locking Bone Plate System III are made of Ti-6Al-4V ELI Alloy for Surgical Implant Applications (ASTM F136, ISO 5832-3). K-Wires are additionally made of CrNiMo Stainless Steel for Surgical Implants (ASTM F138, ISO 5832-1).

AI/ML Overview

The information provided describes the Merete Locking Bone Plate System III, a medical device for bone fixation. The document focuses on the regulatory submission to the FDA (510(k)) and the mechanical testing conducted to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, primarily drawing from the "Mechanical testing" section:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a table format. However, it does mention the types of mechanical tests performed and the general outcome.

Acceptance Criteria (Implied)	Reported Device Performance
Device meets mechanical properties necessary for intended use.	Dynamic 4-point bending fatigue test (per ASTM F382-2003 and ISO 9585): "All tests considered the worst case scenario for the system and were passed successfully." This suggests the device demonstrated sufficient fatigue resistance under simulated loading conditions to withstand the stresses encountered in vivo without failure for the expected service life.
Device performs as well as or better than predicate devices from a mechanical standpoint.	Screw torsion test (per ASTM F543 and ISO 6475): "All tests considered the worst case scenario for the system and were passed successfully." This indicates the screws' torsional strength and resistance to breakage met the required standards and were comparable to or better than predicate devices.
Device meets design requirements based on engineering principles.	Engineering rationale: "All tests considered the worst case scenario for the system and were passed successfully." This implies that theoretical calculations and design considerations were validated through physical testing, confirming the structural integrity and functional performance of the system under various conditions, including "worst-case scenarios."

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

The provided text does not specify the sample size used for the mechanical tests.
The data provenance is from nonclinical mechanical testing conducted by Merete Medical GmbH. This is an in-vitro (laboratory) study, not human or animal data.

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

This question is not applicable to the provided information. The "ground truth" for this device's performance is established through objective mechanical testing against international standards (ASTM and ISO), not through expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. Mechanical tests follow predefined protocols and objective measurements.

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

This question is not applicable. The device is a bone plate system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

This question is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Merete Locking Bone Plate System III is established through objective mechanical measurements against established international standards (ASTM F382-2003, ISO 9585, ASTM F543, ISO 6475). The successful completion of these tests under "worst-case scenarios" serves as the ground truth for its mechanical integrity and functional performance.

8. The Sample Size for the Training Set

This question is not applicable. Mechanical testing of a physical device does not involve "training sets" in the context of machine learning or AI.

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

This question is not applicable. As stated above, there is no "training set" in the context of this device's testing.

Summary

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510(k) Summary of Safety and Effectiveness Information

Date prepared:	November 2, 2012
Submitted by:	Merete Medical GmbHAlt Lankwitz 10212247 Berlin, Germany
FDA Registration Number:	3002949614
Contact Person:	Donna ColemanMerete Medical, Inc.4 Crotty Lane - Suite 118New York International PlazaNew Windsor, NY 12553Phone. 914 967 1532
510(k) No.:	K120787
Device Name:	Merete Locking Bone Plate System III
Device Classification:	21 CRF 888.3030 Single/multiple component metallic bonefixation appliances and accessories (Plate, Fixation, Bone)21 CFR 888.3040 Smooth or threaded metallic bone fixationfastener (Screw, Fixation, Bone; Pin, Fixation, Smooth)
Product Codes:	HRSHWCHTY
Regulatory Class:	Class II

NOV 27### . Predicate Devices:

Merete MetaFixTM Small Fragment Locking Bone Plate System K050457 .
Merete Locking Bone Plate System K090063 .
Merete 3.0 and 3.5 mm Locking Screws K081513 .
Ascension Total Plate System K100502 .
SBI K-Wires K051605 .
Kirschner and Guide Wires K100736 .

Device Description:

Plates, screws and K-Wires of the Merete Locking Bone Plate System III are made of Ti-6Al-4V ELI Alloy for Surgical Implant Applications (ASTM F136, ISO 5832-3). K-Wires are additionally made of CrNiMo Stainless Steel for Surgical Implants (ASTM F138, ISO 5832-1).

Intended use:

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Technological Characteristics:

The components of Merete Locking Bone Plate System III are similar to legally marketed predicate devices listed above in that they share similar indications of use, are manufactured from similar materials and incorporate similar technological characteristics.

Potential risks:

The risks associated with this device are the same as with any metallic internal fixation device. These include but not limited to the following: Delayed or nonunion which may lead to breakage of the implant. Bending or fracture of the implant, metal sensitivity, or allergic reaction to a foreign body. Pain, discomfort, or abnormal sensation due to the presence of the device.

Mechanical testing:

In order to demonstrate that the Merete Locking Bone Plate System III has the mechanical properties necessary to perform its intended use and that the device performs as well as or better than the predicate devices, Merete has conducted nonclinical mechanical testing. This includes:

Dynamic 4-point bending fatigue test (per ASTM F382-2003 and ISO 9585) .
Screw torsion test (per ASTM F543 and ISO 6475) .
Engineering rationale .

All tests considered the worst case scenario for the system and were passed successfully.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the caduceus in a circular fashion.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 27, 2012

Merete Medical GmbH % Merete Medical, Incorporated Ms. Donna Coleman 4 Crotty Lane - Suite 118 New York International Plaza New Windsor, New York 12553

Re: K120787

Trade/Device Name: Merete Locking Bone Plate System III 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, HTY Dated: September 25, 2012 Received: October 1, 2012

Dear Ms. Coleman:

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. Donna Coleman

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ronald P. Jean for

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

Enclosure

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1. Indications for Use Statement

Indications for Use

K12078

510(k) Number (if known):

Device Name: Merete Locking Bone Plate System III

Indications for Use: The Merete Locking Bone Plate System

can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krishna Asundi
for (Division Sign-Off)
Division of Orthopedic Devices

2012.11.21 08:55:15 -05'00'

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.