The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.

Device Description

The Tanda Pearl device consists of a double biting mouth tray made of silicone for fitting both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.

AI/ML Overview

Here's an analysis of the provided text regarding the Tanda Pearl device's acceptance criteria and studies:

Summary of Acceptance Criteria and Device Performance for Tanda Pearl

The provided 510(k) summary for the Tanda Pearl device does not explicitly list quantitative acceptance criteria in a dedicated section with pass/fail thresholds. Instead, it describes performance testing conducted to support substantial equivalence and confirm that the Tanda Pearl performs as intended.

Based on the information, the implicit acceptance criteria are that the device:

Meets relevant safety and performance standards (electrical, EMC, software, integrity, biocompatibility, risk management).
Demonstrates clinical efficacy in teeth whitening.
Demonstrates clinical safety with no significant concerns or severe adverse events.

Here's a table summarizing the reported device performance in relation to these implicit criteria:

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Non-Clinical Performance	Electrical safety	Confirmed as intended (IEC 60601-1: 2005)
	Electromagnetic compatibility (EMC)	Confirmed as intended (IEC 60601-1-2: 2007)
	Device integrity (packaging/transport)	Confirmed as intended (ISTA 2 Series: Partial Simulation Performance Tests-Procedure 2A)
	Biocompatibility	Confirmed as intended (IEC 10993-1:2009)
	Software verification & validation	Confirmed as intended (IEC 62304: 2006)
	Risk analysis	Confirmed as intended (ISO 14971: 2009)
Clinical Performance	Efficacy (teeth whitening)	Produced significantly greater improvement in tooth whitening than control (Vita Shade scores and Delta-E scores). Significant results maintained through 6 months.
	Safety	No significant safety concerns; all reported events were mild in severity and resolved.

Detailed Information about the Studies:

A table of acceptance criteria and the reported device performance: (Provided above)
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): The document states "the results of a single site IRB clinical study". While it confirms a clinical study was performed, the exact sample size for this clinical study is not provided in the given text.
- Data Provenance:
  - Country of Origin: Not explicitly stated, but the original technology developer is "Fluorinex Active Ltd.", which could be an indicator but is not definitive for the study location.
  - Retrospective or Prospective: "single site IRB clinical study" indicates it was a prospective study.
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):
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- The "Vita Shade scores and the Vita Shade Delta-E scores" typically rely on standardized shade guides and visual assessment, which implies trained assessors, but their number and qualifications are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not mentioned. It's unclear how discrepancies in Vita Shade scoring, if any, were handled.
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:
- MRMC Study: No, there is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is not an AI/imaging diagnostic device that would typically involve human readers interpreting images. The study rather compares the device to a control for tooth whitening efficacy.
- Effect Size of AI Assistance: Not applicable, as no AI assistance is mentioned or evaluated in the context of human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: The clinical study evaluated the device (Tanda Pearl) against a control, demonstrating its efficacy and safety. This can be considered a "standalone" evaluation of the device's performance, but not in the context of an "algorithm only" as typically applied to AI/software as a medical device. The device is a physical product directly used by humans.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The efficacy ground truth was established by objective measurements of tooth whitening using "Vita Shade scores and the Vita Shade Delta-E scores." These are widely accepted clinical metrics for tooth shade changes. Safety involved tracking "reported events" and their severity to resolution. This aligns with clinical outcomes data based on standardized clinical assessments.
The sample size for the training set:
- Sample Size (Training Set): Not applicable. This device is not an AI/machine learning device that typically involves a distinct "training set" in the context of model development. The provided clinical study is a performance study to demonstrate the device's function, not to train an algorithm.
How the ground truth for the training set was established:
- Ground Truth (Training Set): Not applicable, as there is no training set for an AI algorithm.

Summary

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K122725

510(k) SUMMARY

Syneron Beauty Inc's Tanda Pearl

NOV 2 7 2012

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Syneron Beauty Inc.

11-380 Jamieson Parkway Cambridge, Ontario, Canada N3C 4N4

Phone: +1-519-651-1177 X 225 Facsimile: +1-519-651-2277

Contact Person: Omri Hayet- COO

Date Prepared: September 5, 2012

Name of Device

Tanda Pearl

Common or Usual Name

Heat source for bleaching teeth

Classification Name

EEG

Predicate Devices

Glo Science LLC's Glo Brilliant Whitening Device (510(k) exempt)

Dentovations Inc.'s South Beach Smile Light Whitening System (K042153)

CAO Group Inc.'s SonX 35 Ultrasonic Bleaching System (K041392)

Intended Use / Indications for Use

The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda The Tanual I can is an over the occalities action of the bleaching agent to improve the whitened appearance of teeth.

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Technological Characteristics

The Tanda Pearl device consists of a double biting mouth tray made of silicone for I he faing both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.

Performance Data

The following performance testing was conducted to support the substantial equivalence of the Tanda Pearl:

electrical safety (IEC 60601-1: 2005) .
electromagnetic compatibility testing (IEC 60601-1-2: 2007) .
device integrity testing (packaging/transport) (ISTA 2 Series: Partial Simulation . Performance Tests- Procedure 2A)
biocompatibility assessment (IEC 10993-1:2009) .
software verification and validation testing and (IEC 62304: 2006) .
risk analysis (ISO 14971: 2009) .

All of these tests confirmed that the Tanda Pearl performs as intended.

Clinical Performance Data

In addition to the non-clinical data that supports the high degree of similarity between the Tanda Pearl and its predicates, the results of a single site IRB clinical study performed under the original technology developer, Fluorinex Active Ltd., further support a finding of substantial equivalence:

The following key results of the study further support the efficacy and safety of the Tanda Pearl device:

The Tanda Pearl device produced significantly greater improvement in tooth . whitening than the control, as measured using both the Vita Shade scores and the Vita Shade Delta-E scores. Significant results were maintained through 6 months.
With respect to safety, no significant safety concerns were noted and all reported . events associated with the Tanda Pearl device were rated as mild in severity and all were followed to resolution.

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Substantial Equivalence

The Tanda Pearl is substantially equivalent to the Glo Science LLC's Glo Brilliant Whitening Device (510(k)-Exempt), Dentovations Inc.'s South Beach Smile Light Whitening System (K042153) and the CAO Group Inc.'s SonX 35 Ultrasonic Bleaching System (K041392).

The Tanda Pearl has similar intended use, similar technological characteristics, and principles of operation as its predicate devices. The technological differences between the Tanda Pearl and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that these minor differences do not adversely impact the safety of the device for its intended use. The Tanda Pearl is substantially equivalent.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Syneron Beauty, Incorporated C/O Janice M. Hogan, Esq. Partner Hogan Lovells US, Limited Liability Partnership 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

NOV 2 7 2012

Re: K122725

Trade/Device Name: Tanda Pearl Regulation Number: 21 CFR 872.6475 Regulation Name: Heat Source for Bleaching Teeth Regulatory Class: I Product Code: EEG Dated: November 16, 2012 Received: November 20, 2012

Dear Ms. Hogan:

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.

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Page 2 - Ms. Hogan

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,

Kwame O. Ulmer ------

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

Radiological Health

Enclosure

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Indications for Use Statement

K122725

510(k) Number (if known):

Device Name: Tanda Pearl

Indications for Use: The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Robert S. Betz 2012.11.21 12:13:21=05'00'

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

Page of

K 22.725 510(k) Number:_

Regulation Number and Section

§ 872.6475 Heat source for bleaching teeth.

(a)
Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.