The Merete 3.0 mm and 3.5 mm Locking Screws are intended to be used in combination with Merete Locking plates for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

Device Description

The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Locking screws/plates incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm to 32 mm in 2 mm increments.

AI/ML Overview

The provided text is a 510(k) summary for the Merete 3.0 mm and 3.5 mm Locking Screws. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.

Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria, as it relates to performance metrics typical for AI/medical device studies (e.g., sensitivity, specificity, accuracy).

However, I can extract information relevant to the substantial equivalence determination and the nature of the device:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table of acceptance criteria and reported device performance in terms of typical performance metrics like sensitivity, specificity, or accuracy.
Instead, the "performance" demonstrated for a 510(k) is primarily based on substantial equivalence to predicate devices. The "technological characteristics" are the basis for this equivalence.
Technological Characteristics (from the document): The Merete 3.0 mm and 3.5 mm Locking Screws are similar to the screws of the legally marketed predicate devices listed above in that they share similar indications for use, are similar and incorporate similar technological manufactured from characteristics.

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

Not applicable. This document describes a 510(k) submission for metallic bone fixation fasteners. It does not involve a "test set" of data or patient cases in the context of an AI/diagnostic device study. The evaluation focuses on engineering parameters, material properties, and comparison to existing devices.

3. 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 test set is not established for this type of device submission.

4. Adjudication method for the test set:

Not applicable. No test set or human adjudication method is described.

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:

Not applicable. This device is a mechanical bone fixation fastener, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device does not involve an algorithm.

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

Not applicable. Ground truth in the context of diagnostic or AI device performance is not relevant here. The "ground truth" for a 510(k) submission largely revolves around demonstrating that the new device is as safe and effective as existing legally marketed predicate devices, often through engineering analysis, material testing, and comparison of design and intended use.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set or associated ground truth establishment process for this type of device.

In summary: The provided document is a 510(k) summary for a medical device (locking screws) and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use. It does not involve performance studies in the context of AI or diagnostic devices, and therefore, most of the requested information is not present.

Summary

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Summary of Safety and Effectiveness 3

Kossis13 pg 1 of 2

Submitted by:	Merete Medical GmbHAlt Lankwitz 102,12247 Berlin, Germany
FDA Registration Number:	3002949614	JUL 1 8 2008
Contact Person:	Jörg MietznerMerete Medical, Inc.49 Purchase StreetRye, New York 10580Phone: 914 967 1532
Device Name:	Merete 3.0 mm and 3.5 mm Locking Screws
Device Classification:	21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener.
Product Code:	HWC
Proposed Regulatory Class:	Class II

Predicate Device:

Synthes Small Fragment Locking Compression Plate (LCP) K000684 -
Smith & Nephew Locking Bone Plate System K033669 -
DARCO Locking Bone Plate System K061808 -
Merete MetaFix Small Fragment Locking Bone Plate System K050457 -
Merete BLP Small Fragment locking Bone Plate System K063487 -

Device Description:

Intended use:

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Technological Characteristics:

K051513 pg 2 of 2

The Merete 3.0 mm and 3.5 mm Locking Screws are similar to the screws of the legally marketed predicate devices listed above in that they share similar indications for use, are similar and incorporate similar technological manufactured from 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 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2008

Merete Medical, Inc. % Mr. Jörg Mietzner 49 Purchase Street Rye, NY 10580

Re: K081513 Trade/Device Name: Merete 3.0 mm and 3.5 mm Locking Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 30, 2008 Received: May 30, 2008

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Jörg Mietzner

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mullison

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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Indications for Use 2

Indications for Use

510(k) Number (if known): KOS | 5 | 3

Device Name: Merete 3.0 mm and 3.5 mm Locking Screws

Indications for Use:

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

(Division Sign-Off)
	Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,
and Neurological DevicesMerete Medical GmbH
510(k) Number K081513

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.