The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave™ Molar Handpiece, the System is indicated for 1 and 200 molar teeth. When used with the Sonendo GentleWave™ Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.

Device Description

The Sonendo GentleWave System (Console and Handpiece) delivers a stream of degassed treatment fluids into the tooth. The treatment fluids delivered to the tooth include a 3% Sodium Hypochlorite (NaOCI) solution and an 8% Ethylenediaminetetraacetic (EDTA) solution which are commonly utilized in traditional endodontic treatments. The stream of solutions delivered into the tooth come in contact with accumulated fluid and are redirected by a deflection plate, creating hydroacoustic and hydrodynamic effects which result in removal of organic and inorganic debris from the root canals. The Console collects the treatment fluid from the tooth into a waste collection canister.

The GentleWave System requires use with a Sonendo Handpiece which is used to treat 1* and 20 molar teeth or the Anterior/Premolar Handpiece which is used to treat anterior and premolar teeth. The Molar and Anterior/Premolar Handpieces are hand held dental instruments which are connected to the Console and provide treatment fluid delivery and waste fluid recovery. The Molar Handpiece is used with various accessories provided with the System. Both the Molar and Anterior/Premolar Handpieces are provided sterile and intended for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the Sonendo GentleWave™ System, an ultrasonic scaler intended for root canal therapy. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and validation study results for a new AI/software component.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI device cannot be entirely extracted from this document, as it describes a physical medical device.

However, I can extract information related to the software validation which is mentioned and could be considered a component of the device's overall performance.

Here's the closest possible interpretation of your request based on the provided text, focusing on the software component where applicable, and noting limitations:

Description of Acceptance Criteria and Study for Sonendo GentleWave™ System

The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. The 510(k) summary indicates that "all necessary performance testing has been conducted... to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended."

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category (where applicable to AI/Software)	Acceptance Criteria/Test	Reported Device Performance	Reference
Software Validation	Validated per FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005."	Passed all validation tests.	Performance Data section
Other Device Performance Tests	Sterility	Sterile per ISO 11137-1,-2	Performance Data section
	Biocompatibility	Biocompatible per ISO 10993-1, -5, -10, -11	Performance Data section
	Electromagnetic Compliance and Electrical Safety	Certified per IEC 60601-1 and IEC 60601-1-2	Performance Data section
	Thermal Test (External Tooth Surface)	Determined temperature generated on the external surface of the tooth.	Performance Data section (Internal Test Method)
	Cavitation Test	Evaluated transient cavitation bubbles which clean root canals.	Performance Data section (Internal Test Method)
	Hydroacoustics Test	Demonstrated hydroacoustic characteristics of the device.	Performance Data section (Internal Test Method)
	Cleaning Test	Demonstrated cleaning efficacy of the device on extracted teeth.	Performance Data section (Internal Test Method)
	Apical Pressure Test	Determined hydraulic pressure exerted at the apical terminus.	Performance Data section (Internal Test Method)
	Apical Extrusion Test	Measured relative volume of treatment fluid extruded through the apical terminus.	Performance Data section (Internal Test Method)

2. Sample Size Used for the Test Set and Data Provenance

For Software: The document states "Software: Validated per FDA Guidance." This generally implies that testing was performed on the software, but the specific sample size (e.g., number of test cases, scenarios, or patients if applicable to clinical data in this context) and data provenance (country, retrospective/prospective) are not provided in this summary.
For Cleaning Test: The cleaning efficacy was demonstrated on "extracted teeth." The number of extracted teeth used for this test is not specified. The provenance (e.g., country of origin) of these extracted teeth is also not provided. This was a retrospective test on non-living material.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For Software: This information is not provided. Software validation typically involves system engineers and test specialists, but not necessarily medical experts for ground truth establishment in the same way as, for example, diagnostic imaging AI.
For Other Tests: For the physical device tests (e.g., Cleaning Test), experts (e.g., endodontists or dental researchers) would likely be involved in assessing cleaning efficacy, but the number of experts and their specific qualifications are not mentioned in this summary.

4. Adjudication Method for the Test Set

Not explicitly stated for any of the tests. The document indicates passage of internal test methods and compliance with standards, implying that results met predefined specifications, but the specific adjudication process (e.g., 2+1, 3+1 consensus) for subjective assessments (like cleaning efficacy) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done as described in the document. This type of study is specifically relevant for diagnostic or interpretive AI systems where human readers' performance with and without AI assistance is evaluated. The Sonendo GentleWave™ System is a treatment device, not a diagnostic imaging AI.

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

Given it is a physical device with an embedded software component for control, the "standalone" performance would refer to the device operating according to its specifications. The tests listed (Thermal, Cavitation, Hydroacoustics, Cleaning, Apical Pressure, Apical Extrusion) are demonstrations of the device's function in a standalone manner (without a "human-in-the-loop" influencing its intrinsic operation, though a human operates the device).
However, if "standalone" refers to an AI purely making decisions without human oversight, this is not applicable to this device.

7. The Type of Ground Truth Used

For Software: Ground truth for software validation would typically be defined by the pre-established functional and performance requirements of the software, and whether its outputs (e.g., control signals, UI responses, calculations) match expected values during testing.
For Cleaning Test: The ground truth for "cleaning efficacy" (on extracted teeth) would likely be established through quantitative or qualitative assessment methods (e.g., microscopic evaluation, dye penetration, or histological analysis) to determine the removal of debris or bacteria within the root canal system. The specific method is not detailed, but it would presumably be an expert-determined assessment based on established dental evaluation techniques.
For Other Tests: Ground truth is typically derived from physical measurements (e.g., temperature, pressure, flow rate) according to engineering and scientific principles.

8. The Sample Size for the Training Set

This information is not provided. For a device cleared via 510(k), especially one not primarily an AI/machine learning diagnostic tool, details about a "training set" (in the machine learning sense) are typically not included in this type of summary. The software validation is likely based on traditional software engineering testing rather than AI model training.

9. How the Ground Truth for the Training Set was Established

Not applicable or not provided, as details of an AI-specific training set or its ground truth establishment are absent from this 510(k) summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.

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

May 1, 2015

Sonendo, Inc. Ms. Jenny Fam Senior Director of Regulatory Affairs 26061 Merit Circle, Suite 101 Laguna Hills, California 92653

Re: K143448

Trade/Device Name: Sonendo GentleWave™ System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 30, 2015 Received: March 31, 2015

Dear Ms. Fam:

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. Jenny Fam

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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5.0 Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __K143448

Device Name: Sonendo GentleWave System

Indications for Use:

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use_ (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)

Page 1 of 1_

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510(k) Summary K143448

This 510(k) summary information is being submitted in accordance with 21 CFR 807.92

Applicant	Sonendo, Inc.
Date Prepared	April 28, 2015
Contact	Jenny FamSenior Director, Regulatory Affairs26061 Merit Circle, Suite 101Laguna Hills, CA 92653949-766-3636
Trade Name	Sonendo GentleWave™ System
Common Name	Sonic Cleaning and Irrigation SystemUltrasonic Scaler
Classification	Ultrasonic Scaler
Device Classification	Class II per 21 CFR 872.4850
Product Code	ELC
Predicate Devices	Primary: Sonendo OmniClean Endotherapy System (K133752)Reference: EMS Piezon Master 700 (K093000)

Substantial Equivalence:

The Sonendo GentleWave System is substantially equivalent in intended use, principle of operation and technological characteristics to the Sonendo OmniClean Endotherapy System (K133752) and the EMS Piezon Master 700 (K093000).

Description of the Device Subject to Premarket Notification:

Indications for Use:

The Sonendo GentleWave System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Handpiece, the System is indicated for 1st and

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Image /page/4/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized blue wave-like design on the left, followed by the word "SONENDO" in bold, black capital letters. The wave design is made up of several parallel curved lines, and the word "SONENDO" is in a sans-serif font, with a registered trademark symbol next to the "O".

2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.

Technological Characteristics:

The Sonendo GentleWave System has similar physical and technological characteristics to the predicate devices. The differences in physical (weight, dimensions) and electrical (power usage) characteristics when compared to the EMS Piezon Master do not affect substantial equivalence.

Characteristics	Sonendo GentleWaveSystem (K143448)	Primary Predicate:Sonendo OmniCleanEndotherapy System(K133752)	Reference Predicate:EMS Piezon Master 700(K093000)
Indication for Use	The Sonendo GentleWaveSystem is intended toprepare, clean and irrigateteeth indicated for rootcanal therapy. Whenused with the MolarHandpiece, the System isintended to prepare, cleanand irrigate 1st and 2ndmolar teeth indicated forroot canal therapy. Whenused with theAnterior/PremolarHandpiece, the System isintended to prepare, cleanand irrigate anterior andpremolar teeth indicatedfor root canal therapy.	The Sonendo OmniCleanSystem is intended toprepare, clean and irrigate1st and 2nd molar teethindicated for root canaltherapy.	Intended for use in thefollowing dental andperiodontal applications:● Preparing, cleaning andirrigating root canals● Retrograde preparationof root canals● Removing supra andsub-gingival calculusdeposits and stains fromteeth● Periodontal pocketlavage with simultaneousultrasonic tip movement● Scaling and root planning● Releasing crowns,bridges, inlays and postsas well as condensinggutta percha● Plugging for amalgamcondensation● Cavity preparation,cementing inlays andonlays
Principle of Operation	Generation ofhydroacoustic waves andfluid motion. The tip of thedevice is placed in or ontop of the tooth duringcleaning. Hydroacousticsare created by thetreatment fluid streamflowing through theenclosure and coming intocontact with the fluidinside the tooth at thedistal tip. The fluid streamis dispersed and deflectedby the deflection plate ofthe enclosure creatinghydrodynamics (fluidmotion) within the tooth.	Generation ofhydroacoustic waves andfluid motion. The tip of thedevice is placed in or ontop of the tooth duringcleaning. Hydroacousticsare created by the watertreatment fluid streamflowing through theenclosure and coming intocontact with the fluidinside the tooth at thedistal tip. The fluid streamis dispersed and deflectedby the deflection plate ofthe enclosure creatinghydrodynamics (fluidmotion) within the tooth.	Generation of hydroacousticwaves and fluid motion
Characteristics	Sonendo GentleWaveSystem (K143448)	Primary Predicate:Sonendo OmniCleanEndotherapy System(K133752)	Reference Predicate:EMS Piezon Master 700(K093000)
Treatment Site	Root canal	Root canal	Various, including Rootcanal
Components	Console (Control Unit),Irrigation Fluid Reservoirs,Foot Pedal, Handpieceand Accessories	Console (Control Unit),Irrigation Fluid Reservoirs,Foot Pedal, Handpieceand Accessories	Control Unit, Irrigation FluidReservoirs, Foot Pedal,Handpiece and Instruments
Irrigation Fluids	3% Sodium Hypochlorite(NaOCI) solution and 8%EDTA solution	3% Sodium Hypochlorite(NaOCI) solution and 8%EDTA solution	Various, including 0.3%Sodium Hypochlorite(NaOCI) solution and lowgrade acids
Handpiece Type	Two (2) Offered: MolarHandpiece andAnterior/PremolarHandpiece	One (1) Offered: MolarHandpiece	Universal Handpiece withvarious attachments.
Sterility: Handpiece	Sterile, Single Use Only	Sterile, Single Use Only	User sterilized, Reusable
Sterility: Console	Non-Sterile, UserDisinfected, Reusable	Non-Sterile, UserDisinfected, Reusable	Non-Sterile, UserDisinfected, Reusable
Materials	Medical Grade Materials	Medical Grade Materials	Medical Grade Materials
Flow rate	With Molar Handpiece:45±10 ml/minWith Anterior/PremolarHandpiece: 35±10 ml/min	With Molar Handpiece:50±10 ml/min	50 ml/min
Maximum UltrasonicOutput	21 watts	21 watts	12 watts
Frequency range	With Molar Handpiece:0.5-14 kHzWith Anterior/PremolarHandpiece: 0.5-32 kHz	Molar Handpiece: 0.5-14kHz	24-32 kHz
Supply voltage	100-240V, 50-60Hz	100-120V, 50-60Hz120-240V, 50-60Hz	100-240 VAC/ 50-60 Hz
Power usage	6 VA	6 VA	80 VA
EN 60601-1classification	Class I Applied Part, TypeB, IP 20, unit	Class I Applied Part, TypeB, IP 20, unit	Class I Applied Part, TypeBF, IP 20, unit
Weight	60 kg	59 kg	2.4 kg
Unit Dimensions (mm)	305 x 584 x 1066	305 x 584 x 1066	225 x 280 x 295
Operating conditions	10°-40°C, 30-75% Rh	10°-40°C, 30-75% Rh	10°-40°C, 30-75% Rh

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Image /page/5/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized blue wave-like design on the left, followed by the word "SONENDO" in bold, black letters. The wave design is made up of several curved lines that create a sense of movement. The word "SONENDO" is in a sans-serif font, and there is a small circle to the right of the word.

The differences do not impact substantial equivalence as the differences in the indications and technical specifications are within the range of the identified predicates.

Performance Data:

All necessary performance testing has been conducted on the Sonendo GentleWave System to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests, which were conducted in accordance with noted standards:

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Image /page/6/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized "S" made up of several curved lines on the left, followed by the word "SONENDO" in a bold, sans-serif font. A small circle, likely a registration mark, is present to the upper right of the "O" in "SONENDO". The logo is simple and modern.

Test	Consensus Standard/FDA Guidance/Description
Sterility	Sterile per ISO 11137-1,-2, Sterilization of health care products - Radiation Sterilization
Biocompatibility	Biocompatible per ISO 10993-1, -5, -10, -11, Biological Evaluation of Medical Devices
ElectromagneticCompliance andElectrical Safety	Certified per IEC 60601-1 General Requirements for Basic Safety and EssentialPerformance and IEC 60601-1-2 Medical Electrical Equipment: Safety, RadiofrequencyEmissions and Electromagnetic Immunity.
Software	Validated per FDA Guidance: Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices, 2005.
Thermal Test	Internal Test Method: Determined the temperature generated on the external surface ofthe tooth when receiving treatment with the device.
Cavitation Test	Internal Test Method: Evaluated transient cavitation bubbles which clean root canals.
Hydroacoustics Test	Internal Test Method: Demonstrated hydroacoustic characteristics of the device.
Cleaning Test	Internal Test Method: Demonstrated cleaning efficacy of the device on extracted teeth.
Apical Pressure Test	Internal Test Method: Determined the hydraulic pressure exerted at the apical terminusof the root canal during use of the device.
Apical Extrusion Test	Internal Test Method: Measured the relative volume of treatment fluid extruded throughthe apical terminus during use of the device.

Basis for Determination of Substantial Equivalence:

Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the Sonendo GentleWave System is substantially equivalent to existing legally marketed devices.

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.