The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient.

The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of:

the phalanges,
the metacarpal bones,
the carpal bones,
for arthrodesis,
for corrective osteotomies, and
for subcapital radial head fractures.

The I.T.S. Hand Locking Plates System is not for spinal use.

Device Description

The I.T.S. Hand Locking Plates System -- HLS consists of Predicate small bone trauma implant components commonly found with large companies with orthopedic markets in the United States. The I.T.S. HLS System consists of 1.0 and 1.5mm thick plates in Straight, T-Shape, Y-Shape, L-Shape (Left & Right), Extended and Square Plate configurations (with multiple hole sizing) that utilize both Locking and Non-Locking self-tapping Screws in 1.5mm, 1.8mm and 2.3mm sizes in various lengths. A 2.0mm Headless Compression Screw in various lengths is also available.

All small plate components are manufactured from Commercialy Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/contouring by the surgeon to fit the small bone anatomy. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. small plates and screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured small plate design minimizes soft-tissue irritation for the patient. Associated instrumentation such as Plate Holder, Drills, Drill Guides, Depth Guage, Countersink Reamers, Guide Wire and ancillary instrumentation is available. All small plates and screws are provided Non-Sterile.

AI/ML Overview

This document is a 510(k) summary for the I.T.S. Hand Locking Plates System - HLS, a metallic bone fixation device. It outlines the regulatory classification, device description, intended use, and claims of substantial equivalence to predicate devices. However, it explicitly states that no nonclinical testing was used in the determination of Substantial Equivalence (SE).

Therefore, based on the provided text, there is no study described that proves the device meets specific performance acceptance criteria. The document relies on a comparison to existing predicate devices already on the market through a claim of "Substantial Equivalence."

Here's an analysis based on your requested information, noting that most of the requested details are not present in this type of regulatory submission because an actual performance study was not conducted as part of this specific 510(k) application:

A table of acceptance criteria and the reported device performance:
- Not provided. This document does not present acceptance criteria for device performance (e.g., mechanical strength, fatigue life, biological compatibility) nor does it report performance data from any conducted studies against such criteria. The basis for clearance is Substantial Equivalence to predicate devices.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. No test set or data provenance is mentioned because no non-clinical testing was used for the determination of substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. No experts were used to establish ground truth for a test set as no performance study was conducted.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method is mentioned.
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 is a bone fixation device, not an AI-based diagnostic tool. No MRMC study was conducted or is relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a bone fixation device, not an algorithm. No standalone performance evaluation was conducted.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth was established as no performance study was conducted.
The sample size for the training set:
- Not applicable. There is no training set mentioned or implied as no algorithm or machine learning component is involved.
How the ground truth for the training set was established:
- Not applicable. There is no training set or associated ground truth establishment process mentioned.

Summary based on the document:

The device, I.T.S. Hand Locking Plates System - HLS, obtained FDA clearance based on Substantial Equivalence (SE) to legally marketed predicate devices (Stryker - Hand Plating System, Synthes - LCP Compact Hand 1.5, Biomet/DePuy - ALPS Small Bone Locked Plating System, I.T.S. GmbH - Extremity Fixation Systems). The key statement providing this information is:

"The I.T.S. GmbH Hand Locking Plates System - HLS is Substantially Equivalent (SE) to the Stryker, Synthes, Biomet/DePuy and I.T.S. GmbH bone plate/screw systems. No nonclinical testing was used in the determination of Substantial Equivalence (SE)."

This means the device's acceptance was based on its similarity in material, geometry, design, and indications for use to already cleared devices, rather than on new performance data demonstrating its ability to meet specific acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth.

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

September 26, 2014

I.T.S. GmbH % Mr. Al Lippincott Engineering Consulting Services, Inc. 3150 East 200th Street Prior Lake, Minnesota 55372

Re: K142418 Trade/Device Name: I.T.S. Hand Locking Plates System- HLS Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, KTT, HWC Dated: August 20, 2014 Received: August 28, 2014

Dear Mr. Lippincott:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Al Lippincott

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/Resourcesfor You/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 vours.

Lori A. Wiggins -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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INDICATIONS FOR USE

K142418 page 1 of 1

K142418 510(k) NUMBER:

DEVICE NAME: I.T.S. Hand Locking Plates System - HLS

The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient .

The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of:

the phalanges, 트
the metacarpal bones. ■
트 the carpal bones,
. for arthrodesis,
. for corrective osteotomies, and
. for subcapital radial head fractures.

The I.T.S. Hand Locking Plates System is not for spinal use.

XXXXX AND/OR Over-The-Counter-Use Prescription Use

(21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 | Page

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510(k) Summary of Safety and Effectiveness

SAFE MEDICAL DEVICES ACT OF 1990

510(k) Summary

NAME OF FIRM:	I.T.S. GmbHAutal 28Lassnitzhöehe A-8301AUSTRIAwww.its-implant.com
510(k) FIRM CONTACT:	Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372Tel. No. 952-492-5858e-mail: allippincott@msn.com
DATE:	August 20, 2014
TRADE NAME:	I.T.S. Hand Locking Plates System - HLS
COMMON NAME:	Small Bone Plating System, Compression Screw
CLASSIFICATION:	Plate, Fixation, Bone & Screw, Fixation, Bone
	Smooth or threaded metallic bone fixation appliances andaccessories (per 21 CRF, Sec. 888.3040).
	Single/Multiple Component Metallic Bone Fixation Appliancesand Accessories (per 21 CRF, Sec. 888.3030).
DEVICE PRODUCT CODE:	HRS
SUBSEQUENT PRODUCT CODE:	KTT, HWC
SUBSTANTIALLYEQUIVALENT DEVICES	Stryker - Hand Plating System (K961497 & K060613)Synthes - LCP Compact Hand 1.5 (K092247)Biomet/DePuy - ALPS Small Bone Locked Plating System(K101240, K061748 & K041081)I.T.S. GmbH - Extremity Fixation Systems (K131722)
DEVICE DESCRIPTION:	The I.T.S. Hand Locking Plates System -- HLS consists of Predicatesmall bone trauma implant components commonly found withlarge companies with orthopedic markets in the United States.The I.T.S. HLS System consists of 1.0 and 1.5mm thick plates inStraight, T-Shape, Y-Shape, L-Shape (Left & Right), Extended andSquare Plate configurations (with multiple hole sizing) that utilizeboth Locking and Non-Locking self-tapping Screws in 1.5mm,1.8mm and 2.3mm sizes in various lengths. A 2.0mm HeadlessCompression Screw in various lengths is also available.
	All small plate components are manufactured from CommercialyPure (CP) Titanium material to ASTM F67 and allow for minorintra-operative forming/contouring by the surgeon to fit the smallbone anatomy. All screws consist of a 6-4 Alloyed Titaniummaterial to ASTM F136. All I.T.S. small plates and screws areprocessed with an anodize DOTIZE surface treatment. The low-profile and contoured small plate design minimizes soft-tissueirritation for the patient.Associated instrumentation such as Plate Holder, Drills, DrillGuides, Depth Guage, Countersink Reamers, Guide Wire andancillary instrumentation is available. All small plates and screwsare provided Non-Sterile.
INTENDED USE:	The intended use of the I.T.S. Hand Locking Plates System - HLSis to draw two or more aligned bone fragments together tofacilitate healing in an adult patient.
	The I.T.S. Hand Locking Plates System - HLS is indicated foruse in fracture fixation of:
	the phalanges, the metacarpal bones, the carpal bones, for arthrodesis, for corrective osteotomies, and for subcapital radial head fractures.
	The I.T.S. Hand Locking Plates System is not for spinal use.
EQUIVALENCE:	The I.T.S. GmbH Hand Locking Plates System - HLS isSubstantially Equivalent (SE) to the Stryker, Synthes,Biomet/DePuy and I.T.S. GmbH bone plate/screw systems. Nononclinical testing was used in the determination of SubstantialEquivalence (SE).
SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS	The I.T.S. GmbH Hand Locking Plates System - HLS is Similar inMaterial, Geometry Design/Markings, and Indications to Stryker,Synthes and Biomet/DePuy predicate system(s) currently sold inthe U.S. market.
SUMMARY OF SAFETYAND EFFECTIVENESS:	The I.T.S. GmbH Hand Locking Plates System - HLS is shown tobe safe and effective for use in fracture fixation of small bones inthe hand.

Page 1 of 2

Section XII

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Section XII

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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.