The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.

Device Description

The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). It is used to deliver induction energy to the Smileloc Sleeve. The Smilekey consists of a tip and handle that uses induction (alternating electromagnetic field) to deliver precise energy to the Smileloc. Only the end of the tip is inserted inside the patient's mouth while the handle is hand-held by the operator. The Smilekey is powered by a rechargeable lithium battery inside the handle. The handle also contains an electronic control board that regulates the entire operation, including LED indicators that let the operator know when energy is being applied to the Smileloc Sleeve and when the unlocking procedure has been completed.

AI/ML Overview

The given text describes the Rodo Smilekey, a dental device intended for removing prostheses compatible with the Smileloc Sleeve using induction heating. The document focuses on demonstrating the substantial equivalence of the Rodo Smilekey to a predicate device, the Smileloc Activator, rather than establishing distinct acceptance criteria with specific performance thresholds for a novel diagnostic or treatment outcome.

Instead of traditional accuracy, sensitivity, or specificity metrics often seen in AI/ML performance studies, the performance data provided focuses on safety and functional performance compared to established standards and the predicate device.

Here's an attempt to structure the information based on your request, acknowledging that the nature of the device (a tool for heating/removing dental prostheses) means some of your requested categories may not have direct equivalents:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for a Class II medical device, the "acceptance criteria" are primarily related to safety, functional performance, and substantial equivalence to a predicate device, rather than diagnostic accuracy. No explicit numerical acceptance criteria are provided, but the document states compliance with relevant standards and demonstrates that performance meets safe limits and is equivalent to the predicate.

Acceptance Criteria (Implied by Testing)	Reported Device Performance
Electrical Safety: Compliance with AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012.	Electrical safety testing was conducted according to the specified standard. (Implied compliance).
EMC Testing: Compliance with AAMI/ANSI/IEC 60601-1-2:2014.	EMC testing was conducted according to the specified standard. (Implied compliance).
Biocompatibility: Patient-contacting materials are biocompatible (handle and tip housing). Compliance with ISO 10993-1 and ISO 10993-5 (cytotoxicity).	Biocompatibility evaluation performed. Handle material identical to predicate (K160786). Cytotoxicity testing of tip housing material according to ISO 10993-5:2009. (Implied compliance).
Cleaning and Disinfection: Effective cleaning and disinfection with simulated challenge soiling and organism. Compliance with FDA guidance and AAMI TIR12:2010.	Cleaning and disinfection testing was performed with simulated challenge soiling and organism, following FDA guidance and AAMI TIR12:2010. (Implied effectiveness).
Software Verification and Validation: Compliance with FDA guidance for software in medical devices.	Software verification and validation testing was conducted according to the FDA guidance document "Content of Premarket Submission for Software Contained in Medical Devices." (Implied compliance).
Battery Testing: Compliance with IEC 62133:2012.	Battery testing was conducted according to IEC 62133:2012. (Implied compliance).
Usability: Compliance with IEC 60601-1-6 Edition 3.1 2013.	Usability testing was conducted according to IEC 60601-1-6 Edition 3.1 2013. (Implied compliance).
Thermal Safety: Temperatures during unlocking procedure do not exceed established safety limits (e.g., those in AAMI/ANSI ES60601-1 and Eriksson, AR et al.).	Thermal safety testing (using ASTM F2182-11 guidelines, gel media, and simulated use conditions) demonstrated that temperatures were within safe limits. Maximum implant and abutment temperatures reached during activation remained below safety limits established by AAMI/ANSI ES60601-1:2005/® 2012 and A1:2012, c1:2009/® 2012 and a2:2010/® 2012 and Eriksson, AR et al. Activation times: 5 seconds for acrylic restorations, 9 seconds for non-acrylic restorations. (This is considered safe and effective for its purpose).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing (e.g., electrical safety, EMC, biocompatibility, cleaning, software V&V, battery, usability, thermal safety). These types of tests typically do not involve "test sets" of patient data in the way a diagnostic AI would.

Sample size for test set: Not applicable in the context of patient data for diagnostic/prognostic evaluation. For bench tests, "samples" would refer to the number of devices or materials tested. This specific number is not provided, but the statement implies sufficient units were tested to meet the requirements of the standards.
Data provenance: Not applicable. These are laboratory-based bench tests, not clinical data.

3. 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. The "ground truth" for these types of engineering and safety tests is adherence to established international standards (e.g., ISO, IEC, AAMI/ANSI) and regulatory guidance. Expert clinical opinion for ground truth in a diagnostic sense is not relevant for this device's performance claims.

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

Not applicable, as there is no "test set" of clinical cases requiring expert adjudication.

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 device is a tool for removing dental prostheses, not a diagnostic AI system assisting human readers.

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

This refers to the inherent performance of the device itself (e.g., its ability to heat the Sleeve safely and effectively). The entire "Performance Data" section describes standalone testing of the Rodo Smilekey. It functions as an algorithm itself in the sense of regulating energy delivery and time, and its performance was evaluated independently through bench testing.

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

The "ground truth" for the device's acceptable performance is defined by:

Compliance with internationally recognized engineering and safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 10993-5, IEC 62133, IEC 60601-1-6).
Adherence to FDA guidance documents (e.g., for reprocessing, software validation).
Demonstrating that thermal output (maximum implant/abutment temperature) remains below established safety limits determined by physiological studies (e.g., Eriksson, AR et al.).
Substantial equivalence to a legally marketed predicate device (Rodo Abutment System K160786) based on similar intended use and demonstration that technological differences do not raise new safety or effectiveness concerns.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data. Its function is based on principles of induction heating and electronics, not learned patterns from data.

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

Not applicable, as no training set is used.

Summary

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Rodo Medical, Inc. % Randy Prebula Partner Hogan Lovells US LLP 555 Thirteen Street NW Washington, District of Columbia 20004 May 23, 2018

Re: K180609

Trade/Device Name: Rodo Smilekey Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 8, 2018 Received: March 8, 2018

Dear Randy Prebula:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

Tina Kiang, Ph.D. Acting 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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510(k) Number (if known) K180609

Device Name

Rodo Smilekey

Indications for Use (Describe)

The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY Rodo Medical, Inc.'s Rodo Smilekey (K180609)

Submitter

Company:	Rodo Medical, Inc.
Address:	6399 San Ignacio AvenueSuite 100San Jose, CA 95119
Phone:	408-245-7636
Facsimile:	408-338-6940
Contact Person:	Michael Parsons
Date Prepared:	May 10, 2018

Subject Device

Name of Device:	Rodo Smilekey
Classification Name:	Endosseous Dental Implant Abutment
Regulation:	21 C.F.R. § 872.3630
Regulatory Class:	Class II
Product Code:	NHA

Predicate Device

Company:	Rodo Medical, Inc.
Device Name:	Rodo Abutment System
510(k) Number:	K160786
Regulation:	21 C.F.R. § 872.3630
Product Codes:	NHA

Device Description

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Intended Use / Indications for Use

The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.

Performance Data

The following bench testing was conducted to demonstrate the performance of the Smilekey:

Electrical safety testing according to AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, ● C1:2009/(R)2012 And A2:2010/(R)2012
. EMC testing according to AAMI/ANSI/IEC 60601-1-2:2014
Biocompatibility evaluation of the patient contacting materials .
- Identical Handle material to predicate Smileloc Activator (K160786) O
- FDA guidance document titled, "Use of International Standard ISO 10993-1, O 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", issued on June 16, 2016
- o Cytotoxicity testing of the tip housing material according to ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. Cleaning and disinfection testing with simulated challenge soiling and organism
- FDA guidance document titled, "Reprocessing Medical Devices in Health Care O Settings: Validation Methods and Labeling", issued on May 2, 2011
- AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for O reprocessing in health care facilities: A quide for medical device manufacturers
Software verification and validation testing .
- FDA quidance document titled, "Content of Premarket Submission for Software O Contained in Medical Devices", issued on May 11, 2005
Battery testing according to IEC 62133:2012 .
Usability testing according to IEC 60601-1-6 Edition 3.1 2013
. Thermal safety testing to evaluate the temperature rise on implant, abutment and restoration during the unlocking procedure using the Smilekey induction activator, to ensure that temperatures do not exceed established safety limits.
- ASTM F2182-11 testing guidelines were used which included gel media and O simulated use conditions.
- The thermal safety limits were equivalent to the predicate Smileloc Activator O (K160786).
- The results demonstrated that the temperatures were within safe limits. O

Substantial Equivalence

The proposed Rodo Smilekey and the predicate Smileloc Activator (part of the Rodo Abutment System K160786) have a similar intended use and similar indications of removing the Smileloc Sleeve from the Rodo Abutment. Both devices are intended to activate the Smileloc Sleeve to release a compatible prosthesis with the Rodo Abutment. Although the subject device uses induction heating instead of resistance heating, this difference in technological characteristics does not raise different questions of safety or effectiveness. Both devices deliver energy to increase the temperature of the Smileloc Sleeve. The induction energy is within safe levels for

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the oral application. In addition, the performance of the Rodo Abutment System and the thermal safety was verified and validated using the same scientific methodology as the predicate device. In addition, bench testing of the subject device has demonstrated substantial equivalent performance to the predicate device.

Conclusions

The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). Similar to the predicate Smileloc Activator, the Smilekey uses heat to activate and to remove the Smileloc Sleeve. Although the Smilekey has a different heating method when compared to the Smileloc Activator, this difference in technological characteristics does not raise different questions of safety or effectiveness. Performance bench testing of the Smilekey demonstrated equivalent performance as the predicate device. Thus, the Smilekey can be found substantially equivalent to the predicate device.

	Subject DeviceRodo Smilekey	Predicate DeviceSmileloc Activator of RodoAbutment System (K160786)	Comparison
Indications forUse	The Rodo Smilekey is intended tobe used with the Rodo AbutmentSystem for removing prosthesescompatible with Smileloc Sleeveby using induction heating.	Rodo Abutment System isintended to be used inconjunction with compatibleimplant systems in the maxillaryor mandibular arch to providesupport for crowns, bridges oroverdentures.	The Indications for Use ofthe subject device is derivedfrom the labeling of theSmileloc Activatorcomponent of theoverarching Rodo AbutmentSystem.
Heating Method	Induction heating	Resistance heating	Difference in heatingmethod does not raisedifferent questions of safetyor effectiveness
Type of batterycharge	Lithium Ion	Lithium Ion	Same
Is batteryrechargeable?	Yes	No	Battery rechargeability doesnot raise additionalquestions of safety oreffectiveness
Time needed fortip on crown toactivate	5 seconds for acrylic restorations,9 seconds for non-acrylicrestorations (e.g., lithiumdisilicate, zirconia)	15 seconds	Difference in activation timedoes not raise differentquestions of safety oreffectiveness. Maximumimplant and abutmenttemperatures reachedduring activation remainbelow safety limits.
Maximumimplant/abutmenttemperaturereached duringactivation	Maximum implant and abutmenttemperatures during activationremain below safety limitsestablished by AAMI/ANSIES60601-1:2005/® 2012 andA1:2012, c1:2009/® 2012 anda2:2010/® 2012 and Eriksson, ARet al.	Maximum implant and abutmenttemperatures during activationremain below safety limitsestablished by AAMI/ANSIES60601-1:2005/® 2012 andA1:2012, c1:2009/® 2012 anda2:2010/® 2012 and Eriksson, ARet al.	Same

Table 1: Comparison of Subject and Predicate Devices

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	Subject DeviceRodo Smilekey	Predicate DeviceSmileloc Activator of RodoAbutment System (K160786)	Comparison
Type ofindicators toinform the enduser	LED	LED	Same
Regulation ofenergy delivery	Internal timer	Internal timer	Same
Type of barrieremployed forinfection controlof device	FDA-cleared dental barrier sleeve	FDA-cleared dental barrier sleeve	Same

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)