The Click-It ceramic self-ligating bracket is intended to be used in an orthodontic treatment with the aim of moving teeth. The basic function is the same as the orthodontic brackets for which substantial equivalence is claimed such that the movement of the tooth and remodeling of the mandibular and maxillary bone will occur when gentle sustained pressure is applied to the teeth through the bracket and wire system. The Click-It ceramic self-ligating bracket has self-ligating properties and will include maxillary and mandibular brackets from second bicuspid to second bicuspid. The device consists of a polycrystalline alumina bracket with two polycrystalline alumina jaws, a nickel titanium spring and two nickel titanium pins.

The design of a self-ligating bracket enables the archwire to be ligated to the bracket without the use of auxiliary devices such as wires or elastics. It enables quicker archwire placement without any significant change in the mechanics when compared to the devices for which substantial equivalence is claimed.

As its predicates, Click-It ceramic self-ligating bracket enables several types of tooth movements throughout the treatment such as: tipping, translation (bodily movement), torque, extrusion, rotation, and intrusion.

The Click-It ceramic self ligating brackets are bonded to the buccal and labial surface of teeth and enable the orthodontic treatment.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the "Click-It Ceramic Bracket," an orthodontic bracket. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional sense (e.g., using a test set with ground truth established by experts).

Therefore, many of the requested elements (e.g., sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) are not applicable or not provided in this type of submission. The submission primarily relies on bench and laboratory testing to compare the new device's performance to its predicates and ensure it functions similarly and safely.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by performing "similar to" or "as well as or better than" the predicate devices. The reported device performance is a direct comparison to the predicates in various bench tests.

Acceptance Criterion (Implicit)	Reported Device Performance (Click-It)	Comparison to Predicates
Bond Strength (ISO 11405:2003 (E))	Average 12.44 Mpa	Comparable to predicate devices. De-bonding did not cause enamel damage, performs like predicates.
Friction (wire to bracket frictional characteristics)	Ranks second out of four bracket systems tested.	Closely follows Clarity SL, outperforms Damon 4Clear and In-Ovation C.
Escapement (wire escapement characteristics)	Performed as expected.	Similar to predicate devices. Retains wires in normal orthodontic procedures.
Impact (catastrophic disassembly)	Broke without causing patient harm.	Fractured similarly to predicate devices, not imparting shards into the mouth.
Pull Test (bracket/bond performance)	De-bonded by bond failing in shear at adhesive interface.	Performed as well as or better than predicate devices. Meets predefined acceptance criteria.
Archwire Slot Dimensional Comparison	Dimensionally similar.	Conforms to design specification.
Biocompatibility (ISO 10993)	Complies with ISO 10993.	Meets applicable biocompatibility requirements.

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

Test Set Sample Size: Not explicitly stated for each test. For example, for "Shear Bond Strength," an "Average 12.44 Mpa" is given, implying a number of tests were conducted to calculate an average, but the sample size (n) is not provided.
Data Provenance: The document describes "Bench and laboratory testing" conducted by TP Orthodontics, Inc. (the manufacturer). This is prospective testing specifically designed for the 510(k) submission. The country of origin of the data is implicitly the USA, where the testing was likely overseen, corresponding to the manufacturer's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This type of device relies on engineering and material performance testing rather than expert-derived ground truth or clinical outcomes. The "ground truth" for these tests is based on established engineering standards (e.g., ISO 11405 for bond strength) and measurable physical properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. As the tests are based on objective physical measurements and comparisons to standards or predicate devices, there is no expert adjudication process in this context.

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 is a hardware medical device (orthodontic bracket) and does not involve AI or human readers for diagnostic interpretation.

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

Not Applicable. This device is a physical orthodontic bracket, not an algorithm.

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

The "ground truth" for these tests is based on established engineering and material science standards and physical measurements. For example, shear bond strength is measured against the ISO 11405 standard, and biocompatibility is assessed against ISO 10993. The "performance" of predicate devices also serves as a benchmark for comparison.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this device. The development process involves design, material selection, and then bench testing, not machine learning or algorithm training.

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

Not Applicable. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for an orthodontic bracket, which establishes substantial equivalence through bench and laboratory performance testing against legally marketed predicate devices and international standards, rather than clinical studies involving expert-adjudicated ground truth or AI performance metrics.

Summary

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MAY 1 3 2011

4. 510(k) Summary

TP Orthodontics, Inc. 100 Center Plaza La Porte, IN 46350-9672 USA Tel: 219-785-2591 Fax: 219-324-3029 Internet: www.tportho.com E-mail: info@tpotho.com

Contact: Date Prepared: Proprietary Name: Common Name: Classification Name: Robin Intagliata October 18, 2010 Click-It Ceramic Bracket Orthodontic Bracket, Ceramic, Orthodontic 21 CFR 872.5470

Device for Which Substantial Equivalence is Claimed

Ormco Corporation, Damon 4Clear (K081415) Dentsply International, In-Ovation C (K060837) 3M Unitek Corporation, Clarity Modified Ceramic Bracket (K062305)

Device Description

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The Click-It ceramic self ligating brackets are bonded to the buccal and labial surface of teeth and enable the orthodontic treatment.

Intended Use of the Device

The Click-It ceramic self-ligating bracket is intended to be used in an orthodontic treatment with the aim of moving teeth.

Technological Characteristics

Click-It can be considered substantially equivalent to the predicate orthodontic products legally marketed. The devices that substantial equivalence is claimed are; In-OvotionC by Dentsply International, Clarity Modified Ceramic Brocket by 3M Unitek Corporation and Damon 4Clear by Ormco Corporation as shown in Table 4-1. All the devices with substantial equivalence are ceramic self-ligating brackets intended to be used in an orthodontic treatment with the aim of moving teeth. All the devices with substantial equivalence when used in traditional treatment are bonded to the labial and buccal surfaces of the patient's teeth after which an archwire is ligated into the slot of each bracket. The combination of brackets, archwire and auxiliaries results in corrective forces moving the teeth into optimal positions are partially predetermined by the predefined tips, torques, and In/Out values utilized by the proven treatment prescription such as Roth, MBT or similar industry prescriptions listed in table 4.1 under "Available prescriptions". The ligating mechanism present in these brackets enables selfligation through the device design, eliminating the need of elastomeric or metallic ligatures. In special cases where self-ligation is difficult to achieve, standard ligatures may be used. Auxiliaries may be used together with the bracket/archwire/ligatures to increase the effectiveness of the orthodontic treatment.

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Table 4-1. Product characteristics

Product Name	Click-It	In-OvationC	Clarity ModifiedCeramic Bracket	Damon 4Clear
510(k) Number	N/A	K060837	K062305	K081415
Class	II	II	II	II
Product Code	NJM	NJM	NJM	NJM
Manufacturer	TP Orthodontics	DentsplyInternational	3M UnitekCorporation	OrmcoCorporation
Intended use	For use inorthodontictreatment withthe aim ofmoving teeth	For orthodonticmovement ofnatural teeth,excluding themandibularbicuspid teeth	For use inorthodontictreatment	Aid in themovement ofpatient teethduringorthodontictreatment
MaterialComposition	Polycrystallinealumina and NiTi	Polycrystallinealumina andrhodium-coatedCoballoy	Polycrystallinealumina,stainless steeland NiTi	Polycrystallinealumina and NiTi
Bracket Design	Self-Ligating	Self-Ligating	Self-Ligating	Self-Ligating
Movable (ligating)member	Jaws	Spring clip	Mesial anddistal C clips	Sliding door
Standards	ASTM F2063-05ISO 11405-2003ISO 10993 SEC 5,10, 11	Unknown	ASTM F2063-05	ASTM F2063-05
Biocompatibility	Compliant asapplicable toISO 10993	Standard usedunknown	Standard usedunknown	Standard usedunknown
Shear BondStrength*	Average12.44 Mpa	Average5.63 Mpa	Average16.54 Mpa	Average6.62 Mpa
Available SlotSizes	0.022"	0.018", 0.022"	0.018", 0.022"	0.022"
AvailablePrescriptions	MBT	Roncone, Roth	Ricketts, MBT,Roth	Low, Standard,Super Torque

*Shear Bond Strength tested in accordance with ISO11405

Performance Testing

The Click-It orthodontic appliance has the same intended use as the predicates and similar technological characteristics. Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of ceramic self ligating brackets. The following tests have been conducted:

Bond strength (ISO 11405:2003 (E)) Comparison of the shear bond strength of the . Click-It and predicate devices. The performance of Click-It brackets were determined to have comparable shear bond strength to the predicate devises. De-bonding of Click-It

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brackets was found not to cause any enamel damage and performs as the predicate devises.

. Friction test – Comparison of the wire to bracket frictional characteristics of the Click-It and predicate devices. Data analysis determined that Click-It ranks second out of the four bracket systems tested, closely following Clarity SL and outperforming both Damon 4Clear and In-Ovation C.
. Escapement test - Comparison of wire escapement characteristics of the subject and predicate devices. The Click-It brackets performed as expected in a manner similar to the predicate devices. Click-It brackets were found to retain the wires in normal orthodontic procedures. More severe case will require additional ligatures.
. lmpact test - Comparison of the catastrophic disassembly of the subject and predicate devices should the brackets fail from an impact. The Click-It bracket broke in such a manner not to cause the patient harm. The broken parts were of sufficient size to be easily expelled from the mouth. Any particles that cannot be seen by the naked eye could be ingested and expelled without harm to the patient. The Click-It bracket performed as expected fracturing in a manner that does not impart shards into the patient's mouth and failed in a similar fashion to the predicate devices.
Pull test Comparison of the bracket/bond performance of the subject and predicate ● devices. The Click-It bracket de-bonded by the bond failing in shear at the bracket/adhesive interface. This is how a bracket should fail and the Click-It performed as well as or better then the predicate devices. The Click-It brackets also meet the predefined acceptance criteria set forth in the testing.
Archwire Slot Dimensional Comparison Comparison of the archwire slot characteristics o of the subject and predicate devices. The Click-it bracket is dimensionally similar to the predicate devices and conforms to the design specification. The archwire slot is of a design that will allow the Click-It to perform properly.

Test results demonstrated that the Click-It ceramic self ligating brackets comply with the predetermined requirements and preformed similar to predicate devices.

Biocompatibility Testing

Click-it was found to meet the biocompatibility requirements set forth in the appropriate sections of ISO 10993. The click-It bracket meets applicable biocompatibility requirements as listed in section 14 and is safe for use.

Safety and Effectiveness Conclusion

Based on the comparison of devices and performance testing results, TP Orthodontics, Inc. concludes that the Click-It device is safe and effective and substantially equivalent to the predicate devices as described herein. ·

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is presented in black and white.

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

MAR - 8 2012

TP Orthodontic, Incorporated C/O Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K111234

Trade/Device Name: Click-it Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Brackets Regulatory Class: II Product Code: NJM Dated: April 29, 2011 Received: May 2, 2011

Dear Ms. Wilkerson:

This letter corrects our substantially equivalent letter of May 13, 2011.

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 (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 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.

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Page 2 - Ms. Wilkerson

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 (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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Indications for Use

510(k) Number (if known):

Device Name: Click-It

Indications For Use:

The Click-It ceramic self-ligating bracket is intended to be used in an orthodontic treatment with the aim of moving teeth.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(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)

Division Sign-Off)
Division of Anesthesiology, General Hospital	Page
fection Control, Dental Devices
!0(k) Number:	K111234

e 1 of 1

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.