The LINOS MOH Hand Plating System consists of plates of various shapes and thicknesses for bone fixation. Plate features include a low profile with angulated-locking threaded screw holes. The system also includes locking and non-locking screws of various lengths and diameters and the necessary instruments to facilitate placement of the implants. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the existing plates and screws in the previously cleared KLS Martin Hand Plating System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the LINOS MOH Hand Plating System, based on the provided documents:

The provided documents describe a Special 510(k) submission for the LINOS MOH Hand Plating System, where the device is considered substantially equivalent to a previously cleared predicate device (KLS Martin Hand Plating System, K040598). This type of submission focuses on demonstrating equivalence to an existing device rather than proving de novo performance against a new set of clinical acceptance criteria. Therefore, the "acceptance criteria" discussed here relate to the device meeting performance requirements comparable to its predicate, rather than independently established goals for a new kind of device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirements)	Reported Device Performance
Material Composition (matching predicate)	CP Titanium or Ti-6Al-4V Titanium Alloy (Matches predicate)
Intended Use (matching predicate)	Stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes. (Matches predicate)
Anatomical Sites (matching predicate)	Small bones of the hand, wrist, fingers, feet, ankles, toes (Matches predicate)
Sterilization Method (matching predicate)	Provided Nonsterile (Steam) (Matches predicate)
Plate Geometry (matching predicate for core feature)	Pre-curved to follow natural curves of hand and feet bones (Matches predicate. The new system expands to include threaded plates, while predicate was non-threaded, but this is a modification and not a change to the core pre-curved geometry.)
Plate Thickness Range (matching predicate)	0.6mm – 3.0mm (Matches predicate)
Screw Diameter Range (matching predicate)	1.0mm – 2.7mm (Matches predicate)
Screw Length Range (matching predicate)	2mm – 32mm (Matches predicate)
Mechanical Performance (Fatigue, Bending, Torsion strengths) (per ASTM F382-99 and ASTM F543-13)	Met performance requirements and demonstrated to be as safe and effective as their predicate devices through mechanical testing. (Specific values are not provided, only stating compliance with standards and equivalence to predicate)
Risk Management (per ISO 14971:2007)	Evaluation demonstrated design change did not present hazards outside acceptability criteria, and risk-related issues were controlled and verified during design control review process. (Demonstrates adherence to risk management standards and internal controls)

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

Test Set Sample Size: The documents do not specify a "test set" in the context of clinical data. The evaluation was primarily based on nonclinical mechanical testing and comparison of technological characteristics to a predicate device.
Data Provenance: The nonclinical mechanical testing was performed in accordance with ASTM (American Society for Testing and Materials) standards. The results from these tests are generally from laboratory settings, not patient data. No "country of origin of the data" or "retrospective/prospective" study design is applicable as this was not a human clinical study.

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

This information is not applicable as there was no clinical test set requiring expert ground truth or human readers. The evaluation was based on engineering and performance specifications and comparison to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set requiring adjudication.

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

No MRMC comparative effectiveness study was done. This submission is for a medical implant (bone plating system) and its modifications, not a diagnostic imaging or AI-assisted device that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study was done. This device is a physical medical implant, not an algorithm or software-based device.

7. Type of Ground Truth Used

The "ground truth" for the nonclinical testing was defined by the performance requirements outlined in ASTM F382-99 and ASTM F543-13, demonstrating that the device meets safety and efficacy standards by performing comparably to the predicate device under mechanical stress. For the substantial equivalence claim, the ground truth was the established characteristics and performance of the legally marketed predicate device.

8. Sample Size for the Training Set

This information is not applicable. "Training set" typically refers to data used to train machine learning models. This submission is for a physical medical device, not an AI/ML product.

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

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for KLS Martin LP. The letters "KLS" are in bold black font, while "martin" is in a white font with a black outline. The letters "LP" are in bold black font, similar to the "KLS".

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartin.com

K141489 (pg 1/3)

Special 510(k) Summarv Section 21 CFR 807.92

JUL 2 4 2014

Submitter:	KLS Martin L.P.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Jennifer DamatoDirector of Quality Mgt and Regulatory AffairsPhone: 800-625-1557Fax: 904-641-7378
Date Prepared:	June 2, 2014
Trade Name:	LINOS MOH Hand Plating System
Common Name:	Plate, Fixation, Bone
Classification:	Single/multiple component metallic bone fixation appliancesand accessories.Class II, 21 CFR 888.3030, Product Code HRS
Predicate Devices:	KLS Martin Hand Plating System (K040598)

Device Description:

Intended Use:

The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes. This is the same intended use as previously cleared for the KLS Martin Hand Plating System, K040598.

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P.O. Box 16369 ● Jacksonville, FL 32245-6369
904-641-7746 or 800-625-1557 • Fax 904-641-7378
www.klsmartin.com

echnological Characteristics/Substantial Equivalence

	LINOS MOH Hand Plating System	KLS Martin Hand Plating System - Primary Predicate(K040598)
Intended Use	The LINOS MOH Hand Plating System is used for stabilizationand fixation of fractures, revision procedures, joint fusion andreconstruction of small bones of the hand, wrist, fingers, feet,ankles and toes.	The KLS Martin Hand Plating System is used for stabilizationand fixation of fractures, revision procedures, joint fusion andreconstruction of small bones of the hand, wrist, fingers, feet,ankles and toes.
Anatomical Sites	Small bones of the hand, wrist, fingers, feet, ankles, toes	Small bones of the hand, wrist, fingers, feet, ankles, toes
Material	CP Titanium or Ti-6Al-4V Titanium Alloy	CP Titanium or Ti-6Al-4V Titanium Alloy
Plate Geometry	Pre-curved to follow the natural curves of the hand and feet bones	Pre-curved to follow the natural curves of the hand and feet bones
Sterilization	Provided Nonsterile (Steam)	Provided Nonsterile (Steam)
Plate Thickness	0.6mm – 3.0mm	0.6mm – 3.0mm
Screw Diameter	1.0mm – 2.7mm	1.0mm – 2.7mm
Screw Length	2mm – 32mm	2mm – 32mm
Screw Style	smartDrive® (locking and non-locking)	Centre-Drive® (non-locking)
Plate Style	Threaded and Non-Threaded	Non-Threaded

5-2

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Image /page/2/Picture/0 description: The image shows the text "KLS martin LP." in a stylized font. The letters "KLS" and "LP" are solid black, while the letters "martin" are outlined in black with a stippled fill. The text appears to be a logo or brand name.

P.O. Box 16369 · Jacksonville. FL 32245-6369 904-641-7746 or 800-625-1557 · Fax 904-641-7378 www.klsmartin.com

K141489 (pg 3/3)

Nonclinical Testing:

A risk analysis was performed in accordance with ISO 14971:2007, "Medical Devices Application of Risk Management to Medical Devices. The evaluation demonstrated that the design change did not present any hazards outside the criteria of acceptability and any risk-related issues were controlled and verified during the design control review process. The same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate, K040598.

Mechanical testing was conducted according to ASTM F382-99 and ASTM F543-13, which demonstrated the subject devices met performance requirements and are as safe and effective as their predicate devices.

Substantial Equivalence Conclusion:

The LINOS MOH Hand Plating System has the same intended use, function, specifications, and is identical in materials and manufacturing processes as the predicate, the KLS Martin Hand Plating System. The LINOS MOH Hand Plating System differs from the predicate in that the product line will be expanded to include screws in non-locking and locking configurations with an updated screw head. The similarities in technological characteristics do not raise new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate device.

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Public Health Service

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles a human figure embracing or protecting another figure, which is a common representation of health and human services.

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

July 24, 2014

KLS Martin L.P. Ms. Jennifer Damato Director of Quality Management and Regulatory Affairs 11201 Saint John Industrial Parkway South Jacksonville, Florida 32246

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K141489

Trade/Device Name: LINOS MOH Hand Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Sing/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: June 26, 2014 Received: June 27, 2014

Dear Ms. Damato:

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

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Page 2 - Ms. Jennifer Damato

(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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

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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Indications for Use

SECTION 4

510(k) Number (if known):

K141489 (pg 1/1)

LINOS MOH Hand Plating System Device Name:

Indications for Use:

The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures. revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.