The Clavicle Locking Plating System consists of a range of plates and screws for clavicle surgery. Each device is manufactured from titanium and color anodized. The Clavicle Locking Plating System will be provided non-sterile for steam sterilization by health care professional's prior use.

AI/ML Overview

The provided text describes the 510(k) summary for the Newclip Clavicle Locking Plating System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing, rather than human-in-the-loop studies, standalone AI performance, or detailed clinical efficacy trials.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific numerical thresholds that the Newclip device must meet beyond being "substantially equivalent" to predicate devices. Instead, the "acceptance criteria" are implicitly met by demonstrating comparable mechanical performance to established predicate devices under specific ASTM standards.

Acceptance Criteria (Implied)	Reported Device Performance
Comparative Bending Test on Clavicle plates (according to ASTM F 382-99 Annex A1)	The Newclip Clavicle Locking Plating System passed comparative bending tests on clavicle plates, demonstrating performance comparable to predicate devices. The exact numerical results are not provided, only the conclusion of successful comparison.
Comparative Fatigue Test on Lateral Clavicle plates (according to ASTM F 382-99 Annex A2)	The Newclip Clavicle Locking Plating System passed comparative fatigue tests on lateral clavicle plates, demonstrating performance comparable to predicate devices. The exact numerical results are not provided, only the conclusion of successful comparison.
Comparative Torsional Test on each type of screws (according to ASTM F543-07 Annex A1)	The Newclip Clavicle Locking Plating System passed comparative torsional tests on its screws, demonstrating performance comparable to predicate devices. The exact numerical results are not provided, only the conclusion of successful comparison.
Comparative Mechanical Pullout Test on each type of screws (according to ASTM F543-07 Annex A3)	The Newclip Clavicle Locking Plating System passed comparative mechanical pullout tests on its screws, demonstrating performance comparable to predicate devices. The exact numerical results are not provided, only the conclusion of successful comparison.
Material Equivalence (Titanium alloy Ti-6Al-4V ELI)	The device's materials (Titanium alloy Ti-6Al-4V ELI, conforming to ASTM F 136-02a and/or ISO 5832-3) are explicitly stated and implicitly determined to be equivalent or acceptable based on the predicate devices primarily using Titanium (or Stainless Steel in some cases for predicate components).
Intended Use Equivalence	The intended use ("fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle") is directly compared and found to be substantially equivalent to the predicate devices, which have similar indications for clavicle fixation.
Design Equivalence (Anatomic contour, pre-contoured, midshaft/distal clavicle plates, combination of locking and non-locking screws)	The design features (anatomic contour, pre-contoured, midshaft and distal clavicle plates, and combination locking/non-locking screws) are stated to be equivalent to those of the predicate devices. This equivalence in design, along with material and function, supports the substantial equivalence determination.

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

The document does not detail the specific sample sizes (e.g., number of plates, screws) used for each mechanical test. It only states that "comparative" tests were conducted. The "data provenance" is derived from these non-clinical mechanical tests performed according to ASTM standards, not from human or animal data, and thus has no country of origin or retrospective/prospective nature in the typical clinical sense.

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

Not applicable. This is a submission for a medical device (clavicle plating system) based on mechanical testing and substantial equivalence to predicate devices, not on a study involving diagnostic accuracy, therefore no "ground truth" established by human experts in the context of diagnostic interpretation is relevant. The "ground truth" for the mechanical tests would be the established performance characteristics of the predicate devices as defined by the ASTM standards.

4. Adjudication Method for the Test Set

Not applicable, as this is a non-clinical mechanical testing submission, not a study requiring adjudication of expert interpretations.

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 submission is for a physical medical device (clavicle plating system), not a diagnostic algorithm or AI-powered system that involves human readers.

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

Not applicable. This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by existing ASTM international standards for orthopaedic implants (ASTM F 382-99 for plate bending/fatigue and ASTM F543-07 for screw torsional/pullout strength) and comparison to the established mechanical performance of legally marketed predicate devices. The goal is to demonstrate that the Newclip system performs at least as well as these predicate devices under these standard tests.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable, for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below that, the word "TECHNICS" is in smaller, gray letters. Above the word "NEWCLIP" is a curved line that resembles a clip.

K100944
OCT 22 2010

510 (k) Summary for the Newclip Clavicle Locking Plating System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Newclip Clavicle Locking Plating System.

Summary preparation date: September 15, 2010

1. Submitter:

Contact Person:

NEWCLIP TECHNICSZ.A du PâtisRue de la Fontaine GrilléeF-44 690 La Haye-Fouassière - FranceTelephone: (33) 2 28 21 37 12	J.D. WebbThe OrthoMedix Group, Inc.1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199
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Newclip Clavicle Locking Plating 2. Trade name:
System

Medial Clavicle Plates and screws Lateral Clavicle Plates and screws

Common Name:

Classification Name:

Plate, Fixation, Bone (21 CFR part. 888.3030)

Screw, Fixation, Bone (21 CFR part. 888.3040)

Predicate or legally marketed devices which are substantially equivalent: 3.

The Locking Clavicle Plates System of the Congruent Bone Plate System of . Acumed, Inc. (K012655),
The Clavicle Locking Plates of the Peri-Loc Periarticular Locked Plating . System for the Upper Extremity of Smith & Nephew; Inc. (K061352),
The 3.5mm LCP Clavicle Plate System of Synthes (K073186), .
The Claviculaplate with Angular Stability System of I.T.S. Implantat-Technologie-Systeme GmbH (K050852).

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Image /page/1/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is written in large, bold, black letters. Below "NEWCLIP" is the word "TECHNICS" written in smaller, gray letters. Above the word "NEWCLIP" is a black semi-circle.

4. Description of the device:	The Clavicle Locking Plating System consists of a range of plates and screws for clavicle surgery. Each device is manufactured from titanium and color anodized. The Clavicle Locking Plating System will be provided non-sterile for steam sterilization by health care professional's prior use.
Materials:	Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-02a and/or ISO 5832-3).
Function:	The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

5. Substantial equivalence claimed to predicate devices:

The Clavicle Locking Plating System is substantially equivalent to the Locking Clavicle Plates System of the Congruent Bone Plate System of Acumed, Inc. (K012655), the Clavicle Locking Plates of the Peri-Loc Periarticular Locked Plating System for the Upper Extremity of Smith & Nephew; Inc. (K061352), the 3.5mm LCP Clavicle Plate System of Synthes (K073186) and the Claviculaplate with Angular Stability System of I.T.S. Implantat-Technologie-Systeme GmbH (K050852) in terms of intended use, design, materials used, mechanical safety and performance.

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Image /page/2/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below that, in smaller letters, is the word "TECHNICS". Above and to the right of the word "NEWCLIP" is a curved line that resembles a sunrise.

The table below compares the features and characteristics of the Newclip Clavicle Locking Plating System to these predicate devices:

Sponsor	NEWCLIPTECHNICSS.A.S.	I.T.S.	ACUMED, INC.	SYNTHES	SMITH &NEPHEW, INC.
Device Name	NewclipClavicleLockingPlating System	Claviculaplatewith AngularStabilitySystem	CongruentBonePlate SystemClavicle LockingPlates	3.5 mm LCPClavicle PlateSystem	Peri-LocPeriarticularLocked PlatingSystemClavicle LockingPlates
510(K) Number	K100994	K050852	K012655	K073186	K061352
RegulatoryClass	II	II	II	II	II
DeviceClassificationName	Plate, Fixation,Bone	Plate, Fixation,Bone	Plate, Fixation,Bone	Plate, Fixation,Bone	Plate, Fixation,Bone
Product Code	HRS	HRS	HRS	HRS	HRS
Panel Code	888.3030	888.3030	888.3030	888.3030	888.3030
Intended use
Indications forUse	Fixationoffractures,mal-unions,non-unions,andosteotomiesofthe clavicle.	Metaphysial anddiaphysealfracture fixationofacutefractures,malunions,andnon-unionsofthe clavicle.Correctiveosteotomyandopen and closedfractures.	Fixationforfractures,fusions,orosteotomiesforthe clavicle,humerus,radius,ulna,metacarpal,metatarsal,malleolus, tibia,and fibula.	Fixationoffractures,mal-unions,non-unions,andosteotomiesofthe clavicle.	Fixationofpelvic,smalland longbonefractures,includingthoseof thetibia,fibula, femur,and pelvic,osteotomies ofacetabulum,metacarpal,humerus, ulna,radius,calcaneus andclavicle.
Plates design
o Design	AnatomiccontourPre-contoured	AnatomiccontourPre-contoured	AnatomiccontourPre-contoured	AnatomiccontourPre-contoured	AnatomiccontourPre-contoured
Devices
o MidshaftClavicleplates	Yes	Yes	Yes	Yes	Yes
o Distal Clavicleplates	Yes	Yes	Yes	Yes	Yes
o Fixationsystem	Combinationoflocking and non-locking screws	Combinationoflocking and non-locking screws	Combinationoflocking and non-locking screws	Combinationoflocking and non-locking screws	Combinationoflocking and non-locking screws
Materials
o Plates	Titanium	Titanium	Titanium	Titaniumor stainlesssteel	Stainless steel
o Screws	Titanium	Titanium	Titanium	Titaniumor stainlesssteel	Stainless steel
o Anodization	Yes	No	Yes	Yes	No

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Image /page/3/Picture/0 description: The image shows the logo for Newclip Technics. The word "NEWCLIP" is in large, bold, black letters. Below that, in smaller letters, is the word "TECHNICS". Above the word "NEWCLIP" is a curved line that resembles a clip.

6. Intended use:

The implants of the Newclip Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

7. Non-clinical Test Summary:

The following tests were conducted:

Comparative bending test on Clavicle plates according ASTM F 382-99 . Annex Al.
Comparative fatigue test on Lateral Clavicle plates according ASTM F 382 -. 99 - Annex A2.
Comparative torsional test on each type of screws according ASTM F543-07 . Annex A1.
Comparative mechanical pullout test on each type of screws according to . ASTM F543-07 Annex A3.

8. Non-clinical Test Summary:

No clinical studies were performed.

9. Conclusions Nonclinical and Clinical:

The Newclip Clavicle Locking Plating System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

Newclip Technics % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

0(T 2 2 2010

Re: K100944

Trade/Device Name: Clavicle Locking Plate System 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 Dated: September 29, 2010 Received: October 4, 2010

Dear Mr. Webb:

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, 7 rug and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA). 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 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. J.D. Webb

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Barbara Buend

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

Enclosúre

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Image /page/6/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below "NEWCLIP" is the word "TECHNICS" in smaller, lighter letters. Above the word "NEWCLIP" is a curved line that resembles a sunrise.

K100944
OCT 22 2010

INDICATIONS FOR USE

510(k) Number (if known): K1009944

Device Name: Clavicle Locking Plating System

Indications for Use:

The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

Prescription Use AND/OR Part 21 CFR 801 Subpart D)

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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Seneta for mxn

(Division Sign Off Division of Surgical, Inthopedic, and Restorative Devices

510(k) Number K100944

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.