The TUTU ™ LED intraoral curing light is designed to polymerize visible light cure (VLC) dental materials including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials

Device Description

The TuTu7 is a LED curing light that is small and easy to use, vet powerful and swift in curing. It has a compact, lightweight hand piece, with a curved and contoured tip, to allow the light to be positioned and applied anywhere in the oral cavity. The TuTu has 3 different functioning modes, continuous, pulse and ramp. The device peeps every 3 seconds for precise timing of exposure, regardless of mode setting. The rechargeable battery is a Lithium lon, which at full charge can last up to 120 minutes. The TuTu is provided with a battery charger, which also acts as a storage holder for the device. A silicone sheath is provided to refract the light and protect the eyes of the operator.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Invisible Technology TuTu 7 Dental Curing Light, based on the provided 510(k) summary:

This device (TuTu 7 Dental Curing Light) is a physical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/SaMD (which involve performance metrics like sensitivity, specificity, F1 score, etc., against a ground truth) are not fully applicable in the same way.

For a physical medical device like a dental curing light, acceptance criteria generally relate to technical specifications, safety, and functional performance benchmarks that demonstrate substantial equivalence to predicate devices. The "study" here would be various tests and measurements conducted to show the device meets these technical specifications and performs its intended function safely and effectively.

Based on the provided text, the "acceptance criteria" are implied by the comparison to the predicate devices and the physical specifications of the TuTu 7. The 510(k) process primarily focuses on demonstrating substantial equivalence to a currently marketed predicate device, rather than proving efficacy through a large-scale clinical study in the way an AI/SaMD would.

Here's an attempt to structure the information as requested, adapting for a physical device:

Acceptance Criteria and Device Performance for Invisible Technology TuTu 7 Dental Curing Light

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate & Device Description)	Reported Device Performance (TuTu 7)
Intended Use: Polymerize visible light cure (VLC) dental materials (dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials)	Designed for this intended use; functions as a dental curing light.
Wavelength Range: Within typical range for dental curing (e.g., 430-480 nm as per predicates)	380-480 nm
Power Output (Watts mW-cm): Comparable to or exceeding predicate devices (e.g., 950-1200 mW-cm)	1300 mW-cm
Battery Type: Functional, rechargeable battery	2,300 Li-on Battery (rechargeable, lasts up to 120 minutes)
Physical Characteristics (Weight): Light and compact for intraoral use (e.g., 100-220g as per predicates)	142g
Functionality: Multiple curing modes & precise timing	3 different functioning modes (continuous, pulse, ramp), beeps every 3 seconds for precise timing.
Safety: Protection for operator (implied through general controls)	Silicone sheath provided to refract light and protect eyes of operator (specific mention).

2. Sample Size for Test Set and Data Provenance

This information is not applicable in the context of an AI/SaMD's "test set" for performance evaluation against a dataset. For a physical device like a curing light, "testing" refers to laboratory bench testing, electrical safety tests, optical power measurements, etc. The 510(k) summary provided does not detail the specific sample sizes for these types of engineering tests, nor does it specify data provenance in terms of country of origin or retrospective/prospective studies. The "data" would be the results of the engineering and performance testing of the device itself.

3. Number of Experts and Qualifications for Ground Truth

This concept is not applicable as described for an AI/SaMD. There is no "ground truth" established by experts in the context of evaluating the predictive accuracy of a dental curing light. The performance is assessed through objective physical measurements and comparisons to established standards for power, wavelength, and functional operation.

4. Adjudication Method

This concept is not applicable for a physical device. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human annotators when establishing a "ground truth" for a dataset, which is not relevant here.

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

This is not applicable for a dental curing light. MRMC studies are designed to assess the impact of a diagnostic aid (like a CAD system) on human reader performance, which doesn't apply to a device that directly performs a therapeutic function (light curing).

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the TuTu 7 is a physical device, not an algorithm or software. It does not have an "algorithm-only" mode separate from human interaction, nor does it generate diagnostic outputs that would be evaluated for standalone performance.

7. Type of Ground Truth Used

The "ground truth" for this type of device is implicitly defined by:

Engineering specifications and standards: Wavelength range, power output, beam uniformity, heat generation, battery life.
Performance of predicate devices: The TuTu 7 is compared against known, legally marketed predicate devices (SmartLite PS Pen-Style LED Curing Light and Elipar FreeLight) to demonstrate similar fundamental technology and performance characteristics.
Material polymerization efficacy: While not explicitly detailed as a "study" in this summary fragment, the ability of the light to cure dental materials effectively to industry standards would be a critical aspect of its performance validation. This would typically involve testing with various depths/materials to ensure adequate cure.

8. Sample Size for Training Set

This is not applicable. The device is not an AI/SaMD that requires a training set.

9. How Ground Truth for Training Set was Established

This is not applicable as there is no training set for a physical device like this.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The information provided indicates that the "study" for the TuTu 7 Dental Curing Light primarily involved demonstrating its substantial equivalence to two predicate devices, the Dentsply International SmartLite PS Pen-Style LED Curing Light (K041372) and the 3M ESPE AG Elipar FreeLight (K011154).

This demonstration relied on:

Comparative Table of Technological Characteristics: Showing that the TuTu 7 shares the same product code, CFR, and fundamental technology (LED blue light curing) as the predicates.
Specification Comparison: Comparing key performance parameters like wavelength range, power output (watts mW-cm), battery type, weight, and features (e.g., multiple curing times) to the predicates. The TuTu 7 often met or exceeded the specifications of its predicates (e.g., higher power output, comparable wavelength range).
Intended Use Alignment: Confirming that the intended use of the TuTu 7 is identical to that of legally marketed predicate devices.
General Controls Compliance: The device is subject to the general controls provisions of the Act, which include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The FDA's review and determination of substantial equivalence (as indicated in the letter K062735) signifies that the device meets the necessary criteria for market entry, primarily by demonstrating that it is as safe and effective as a legally marketed predecessor device.

Summary

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510(k) Summary Invisible Technology TuTu 7 Dental Curing Light

K062735

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).

807 92(a)(1)

Submitter Information

Invisible Technology (IV-Tech) Nassa B/D 4F, 581 Shinsa-Dong Kangnam-ku, Seoul Korea #135-892

Tae Hee, Cho Contact Person:
September 12, 2006 Date:

807.92(a)(2)

TuTu 7 Trade Name:

Common Name: Dental Curing Light
Classification Name(s): Ultraviolet Activator for Polymerization - 872.6070
Classification Number: EBZ

807.92(a)(3)

Predicate Device(s)

Dentsply International	SmartLite PS Pen-StyleLED Curing Light	K041372
3M ESPE AG	Elipar FreeLight	K011154

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510(k) Summary Invisible Technology TuTu 7 Dental Curing Light 807.92 (a)(4)

Device Description

807.92(a)(5)

Intended Use(s)

807.92(a)(6)

	SmartLite PS LEDCuring LightDENTSPLYK041372	Elipar FreeLight3M ESPE AGK011154	TuTu 7IV-TechThis Submission
Product Code	EBZ	EBZ	EBZ
CFR	872.6070	872.6070	872.6070
WavelengthRange n/m	450-475	430-480	380-480
Watts mW-cm	950	1200	1300
Battery Type	NMH	NHH	2,300 Li-onBattery
Weight	100g	220g	142g
Rotating Tip	Yes	No	No
Built in meter	No	Yes	No
Repl. Bulb	No	No	Yes
Multiple CuringTime	No	Yes	Yes
LED Blue Light	Yes	Yes	Yes

Technological Characteristics

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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 consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of four curved lines that resemble human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2006

Invisible Technology Company, LTD C/O Ms. Allison Scott The Anson Group 11460 North Meridian Street, Suite 150 Carmel, Indiana 46032

Re: K062735

Trade/Device Name: TuTu 7 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: September 12, 2006 Received: September 13, 2006

Dear Ms. Scott:

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.

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Page 2 - Ms. Allison Scott

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.

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Susan Runner

Chiu S. Lin, PhD 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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Indications for Use

510(k) Number (if known): 《O(g L735

Device Name:

ini

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Punner

on Gign-Off) ion of Anesthesiology, General Hospital, con Control, Dental Devices

Number. K062735

Page 1 of of

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.