The Sonendo GentleWave(R) System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave(R) Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave(R) Anterior/Premolar Handpiece, the System is indicated for and premolar teeth.

Device Description

The Sonendo GentleWave® System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave® System is comprised of a Console, and a disposable single-use Handpiece. The Handpiece is offered in two versions: a Molar Handpiece which is intended to be used on 1st and 2nd molar teeth and an Anterior/Premolar Handpiece which is intended to be used on anterior and pre-molar teeth.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the Sonendo GentleWave® System, which is an ultrasonic scaler for root canal therapy. It does not describe a study involving specific acceptance criteria and device performance metrics in the way that would typically be done for a new AI/medical device with diagnostic or prognostic capabilities where accuracy, sensitivity, or specificity are key.

Instead, this document is a submission to demonstrate substantial equivalence to a legally marketed predicate device (Sonendo GentleWave® System K153157) under the FDA's 510(k) pathway. The primary "acceptance criteria" here relate to demonstrating that the modified device (K160905) is as safe and effective as the predicate device, despite a change in the ability to select treatment fluid concentrations.

Therefore, the information requested cannot be fully provided in the context of this document as it focuses on demonstrating equivalence rather than establishing performance against new clinical endpoints or diagnostic accuracy.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

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

The document does not present a table of specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for therapeutic efficacy or diagnostic output since it's an ultrasonic scaler. The "performance data" section states: "Based on the results of this testing, the modified GentleWave System performs as intended and is substantially equivalent to the predicate device." This implies the "acceptance criteria" are related to maintaining equivalence, not necessarily achieving specific clinical outcomes that are quantified in this document.

The key "performance data" criteria mentioned relate to software validation:

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Software validation	"Performs as intended" and "substantially equivalent to the predicate device" after validation in accordance with ANSI/AAMI/IEC 62304:2006
Safety & Effectiveness	Maintained substantial equivalence to predicate device with modified fluid concentration settings.

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

This information is not provided in the document. Software validation typically involves testing against requirements, but the specific "sample size" of test cases for software or the data provenance is not detailed.

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)

This information is not provided. The device is an ultrasonic scaler for root canal therapy; the concept of "ground truth" established by experts for a diagnostic output is not directly applicable in the context described here. The "ground truth" for a therapeutic device performance would typically relate to successful treatment, which is not quantified in this summary.

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

This information is not provided. Not applicable in the context of this 510(k) summary.

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

There is no indication of an MRMC study. This device is a therapeutic device (ultrasonic scaler), not a diagnostic device involving human readers or AI assistance in interpretation. The document explicitly focuses on changes to a therapeutic system and its software, not on interpretive capabilities.

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

This is not applicable for this type of device. The GentleWave System is a physical medical device that prepares, cleans, and irrigates root canals. It has "software-controlled user interface" and "software validation," but it is not an "algorithm" operating in a standalone diagnostic capacity.

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

As noted previously, the concept of a "ground truth" as typically understood for diagnostic devices is not directly applicable here. The substantial equivalence relies on the fundamental scientific technology and indications for use remaining the same, and the modifications (fluid concentration selection) not affecting safety or effectiveness. The "ground truth" for the software validation would be that the software performs according to its specifications. For the device as a whole, it relies on being "substantially equivalent" to a predicate device already deemed safe and effective.

8. The sample size for the training set

This information is not provided. The device is not an AI/ML algorithm that is "trained" on a dataset in the typical sense for a diagnostic device. Software validation tests are run against detailed specifications, not a "training set."

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

This information is not provided and is not applicable as there is no "training set" in the context of an AI/ML algorithm being developed or assessed here.

Summary

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

June 3, 2016

Sonenedo, Inc. Mr. Dan W. Miller Sr. Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance 26061 Merit Circle, Suite 102 Laguna Hills, Ca 92653

Re: K160905

Trade/Device Name: Sonendi Gentle Wave System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: May 2, 2016 Received: May 4, 2016

Dear Mr. Miller:

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 - Mr. Dan W. Miller

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Tina
Kiang -S

for Erin I. Keith, M.S. 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

510(k) Number (if known) K160905

Device Name Sonendo GentleWave(R) System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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6. 510(k) K160905 Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Sonendo, Inc.
DATE PREPARED:	March 31, 2016
CONTACT PERSON:	Dan W. Miller26061 Merit Circle, Suite 102Laguna Hills, CA 92653Phone: 949.766.3636Fax: 949.305.5201
TRADE NAME:	Sonendo GentleWave® System
COMMON NAME:	Sonic Cleaning and Irrigation System
CLASSIFICATIONNAME:	Ultrasonic Scaler
DEVICECLASSIFICATION:	Class 2, per 21 CFR 872.4850
PRODUCT CODE	ELC
PREDICATE DEVICES:	Sonendo GentleWave® System (K153157

Description of the Device Subject to Premarket Notification:

Indication for Use:

The Sonendo GentleWave® System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWaye® Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave® Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.

Substantially Equivalent To:

The Sonendo GentleWave® System is a modified device of the existing Sonendo GentleWave® System. The modified Sonendo GentleWave® System is substantially equivalent in intended use, principal of operation and technological characteristics to the Sonendo GentleWave® System cleared under premarket notification K153157.

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Technical Characteristics:

The Sonendo GentleWave® System has similar physical and technical characteristics to the predicate device. The software controlled user interface has been modified to allow for clinician-determined treatment fluid concentrations with the default fluid concentration setting identical to the concentrations for the predicate K153157 with three setting options to decrease the concentration of the fluids.

Technical Characteristics	Sonendo GentleWave®System (modified)	Sonendo GentleWave®System (K153157)
Function	Preparation, cleaning and irrigationor root canal	SAME
Principle of Operation	Generation of hydroacousticwaves and fluid motion. The tipof the device is placed inside thetooth during cleaning.Hydroacoustics are created by thewater stream flowing through theguide tube and coming intocontact with the fluid inside thetooth at the distal tip. The fluidstream is dispersed and deflectedby the distal end plate of the tubecreating hydrodynamics (fluidmotion) within the tooth.	SAME
Treatment Site	Root canal	SAME
Components	Control UnitIrrigation reservoirsFoot pedalHandpieceAccessories	SAME
Treatment times	Fixed or User selected	SAME
Treatment fluid concentration	Default mode at the concentrationvalue identical to the predicate or3 setting options to decrease theconcentrations of the fluids	Fixed

Each of the technical attributes are present in the predicate device. The modification to use treatment fluids at lower concentrations does not affect the substantial equivalent nature of the modified device, as this change merely allows for ability to select the treatment fluid concentration based on clinical evaluation of the treatment site. This change is consistent with traditional root canal procedures in that it enables the User to utilize treatment fluids with varying concentrations.

Performance Data:

Design control activities and risk analysis were performed in accordance with 21 CFR Part 820.30 and ISO14971:2007, respectively. Based on the changes being made and the risks associated with those changes, the following testing was determined to be necessary:

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Software validation in accordance with ANSI/AAMI/IEC 62304:2006, Medical . device software - Software life cycle processes
Based on the results of this testing, the modified GentleWave System performs as intended and is substantially equivalent to the predicate device.

Basis for Determination of Substantial Equivalence:

The indications for use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The Sonendo GentleWave® System is similar to the predicate device and is determined by Sonendo, Inc. to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.