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.

Device Description

The Merete Locking Bone Plate System consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures, Merete 3.0mm and 3.5mm locking screws and cannulated 3.0mm compression screws. The system is made of titanium alloy Ti-6Al-4V.

AI/ML Overview

The provided text describes a 510(k) submission for the "Merete Locking Bone Plate System" and focuses on its substantial equivalence to predicate devices, rather than a study demonstrating acceptance criteria met by the device itself through performance evaluation.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: The document does not specify quantitative acceptance criteria or report performance metrics for the Merete Locking Bone Plate System. The submission is based on demonstrating substantial equivalence to existing devices.
Sample size used for the test set and the data provenance: No test set or associated data are mentioned for evaluating device performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of a test set requiring ground truth establishment by experts.
Adjudication method for the test set: No test set is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This type of study is not mentioned. The device is a bone plate, not an imaging or diagnostic AI tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is irrelevant for a physical bone plate device.
The type of ground truth used: Not applicable as no performance study is detailed.
The sample size for the training set: Not applicable as this is a physical medical device, not an AI/algorithm-based one.
How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

The 510(k) submission focuses on demonstrating substantial equivalence for the Merete Locking Bone Plate System to legally marketed predicate devices, rather than presenting a study with acceptance criteria and performance data. The FDA's letter states that the device is substantially equivalent "for the indications for use stated in the enclosure" to predicate devices, meaning it has similar technological characteristics, materials, and intended use as devices already on the market. This pathways allows medical devices to be marketed without requiring new clinical trials, if they can show they are as safe and effective as a legally marketed predecessor.

Summary

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510(k) Submission - Merete Locking Bone Plate

2. 510(k) Summary

Submitted by:	Merete Medical GmbHAlt Lankwitz 102,12247 Berlin, Germany	APR 22 2009
FDA Registration Number:	3002949614
Contact Person:	Jörg MietznerMerete Medical, Inc.49 Purchase StreetRye, New York 10580Phone: 914 967 1532
Device Name:	Merete Locking Bone Plate System
Device Classification:	21 CFR 888.3030 Single/multiple componentMetallic bone fixation appliances and accessories
Product Code:	KTT
Proposed Regulatory Class:	Class II

Predicate Device:

DARCO Locking Plate System K067808 ।
Merete BLP™ Small Fragment Locking Bone Plate System K063487 ।
Merete 3.0 mm and 3.5 mm Locking Screws K081513 ﮯ

Device Description:

Intended use:

Technological Characteristics:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus. The caduceus is depicted in black, while the text is also in black against a white background.

Public Health Service

Merete Medical, Inc. % Mr. Jorg Mietzner 49 Purchase Street Rye, New York 10580

APR 22 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K090063

Trade/Device Name: Merete Locking Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: January 9, 2009 · Received: January 23, 2009

Dear Mr. Mietzner:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Jorg Mietzner

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please i contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1. Indications for Use Statement

Indications for Use

510(k) Number (if known): 长 09 006 3

Device Name: Merete Locking Bone Plate System

Indications for Use:

Division of General. I estorative. and Neurological Devices

Prescription Use
(Part 21 CFR 801 Subpart D)

510(k) Number K090063

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)

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.