The Sonendo OmniClean Endotherapy System is a medical device intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy. The Sonendo OmniClean Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.

AI/ML Overview

The provided 510(k) summary for the Sonendo OmniClean Endotherapy System does not contain detailed acceptance criteria or a study dedicated to proving the device meets specific performance metrics in the way often seen in AI/ML performance studies. Instead, it relies on demonstrating substantial equivalence to predicate devices through various performance tests.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of explicit acceptance criteria with corresponding performance results in a quantitative manner (e.g., "Device must achieve X% flow rate accuracy, and it achieved Y%"). Instead, it lists performance data categories and implies that testing within these categories showed the device performs as intended and is similar to predicate devices.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
Simulated Use	Performed as intended, demonstrating substantial equivalence to predicate devices.
EMC and Electrical Safety	Complies with relevant standards, ensuring safe operation.
Thermal Safety	Complies with relevant standards, ensuring safe operation and preventing tissue damage.
Hydroacoustics	Similar hydroacoustic wave generation and fluid motion to predicate devices, confirming the reported Principle of Operation.
Apical Extrusion and Pressure	Demonstrated to be safe and effective, minimizing apical extrusion and maintaining appropriate pressure levels, similar to predicate devices.
Cleaning Effectiveness	Demonstrated effective cleaning of root canals, comparable to predicate devices for its intended use. (Note: Specific metrics or comparative results are not provided in this summary but are implied to be satisfactory for substantial equivalence).
Flow Rate	45 +/- 10 ml/min. (This is a specific technical characteristic, and the testing implicitly confirmed it met this specification.)
Duration of Application	Leak test = 1 minute, Treatment time = 7 minutes and 45 seconds. (These are specific technical characteristics, and the testing implicitly confirmed the device operates within these parameters.)
Irrigation Fluid Compatibility	Compatible with NaOCl, EDTA, and Water. (Testing implicitly confirmed compatibility with these specified fluids, similar to predicates.)

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

The summary does not specify sample sizes for any of the performance tests. It states that "All testing was performed on test units representative of finished devices," but the number of units or teeth/canals tested is not provided.

The data provenance is also not specified. It's generally assumed that such testing for a 510(k) submission would be conducted by the manufacturer (Sonendo, Inc.) in a controlled lab or simulated environment during device development, but details regarding external data, country of origin, retrospective or prospective nature are absent.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided in the context of this 510(k) summary. This device is an endotherapy system for preparing, cleaning, and irrigating root canals, not an AI/ML diagnostic or image analysis device that would typically rely on expert ground truth for test sets.

4. Adjudication Method

This information is not applicable and not provided for the same reasons as #3.

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

A MRMC comparative effectiveness study is not applicable and not mentioned. This type of study investigates the impact of AI assistance on human reader performance, which is not relevant for a physical endotherapy device.

6. Standalone (Algorithm Only) Performance

A standalone algorithm performance study is not applicable for this device, as it is a physical medical device, not an algorithm or software-only product.

7. Type of Ground Truth Used

The concept of "ground truth" in the AI/ML context doesn't directly apply here. The "ground truth" for a physical device like this would be derived from:

Engineering specifications and standards conformance: The device performs according to its design and meets relevant safety and performance standards (e.g., electrical safety, thermal safety).
Biomechanical/physiological effects: Demonstrating that the hydroacoustic waves and fluid motion effectively clean root canals without causing harm (e.g., minimal apical extrusion). This would likely involve in vitro or ex vivo models but not "expert consensus" in the diagnostic sense.
Comparison to predicate devices: The primary "ground truth" or benchmark is the performance of legally marketed predicate devices, demonstrating that the new device is "substantially equivalent" and "performs as intended."

The specific methods for establishing these "truths" (e.g., documented lab tests, measurements, comparative data) are summarized but not detailed.

8. Sample Size for the Training Set

This is not applicable and not provided. This device does not involve a "training set" in the machine learning sense. The development and testing of this device would involve engineering design, prototyping, and various verification and validation tests, not machine learning model training.

9. How Ground Truth for the Training Set Was Established

This is not applicable and not provided for the same reasons as #8.

In summary:

This 510(k) summary for the Sonendo OmniClean Endotherapy System primarily relies on demonstrating substantial equivalence to existing predicate devices. The performance data section lists various categories of testing (Simulated Use, EMC/Electrical Safety, Thermal Safety, Hydroacoustics, Apical Extrusion/Pressure, Cleaning) that were conducted to confirm the device performs as intended and is comparable to its predicates. However, it does not provide quantitative acceptance criteria, specific sample sizes for testing, or details about expert involvement or ground truth establishment in the manner applicable to AI/ML or diagnostic devices.

Summary

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510(k) Summary

1. 510(k) 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:	December 4, 2013
CONTACT PERSON:	Dan W. MillerSonendo, Inc.26061 Merit Circle, Suite 101Laguna Hills, CA 92653Phone: (949) 766.3636 x544
TRADE NAME:	Sonendo OmniClean Endotherapy System
COMMON NAME:	Sonic Cleaning and Irrigation System
CLASSIFICATION NAME:	Ultrasonic Scaler
DEVICE CLASSIFICATION:	Class 2, per 21 CFR 872.4850
PRODUCT CODE	ELC
PREDICATE DEVICES:	Sonendo Endotherapy System (K130025)EMS Piezon Master 700 (K093000)Sonic Air MM 1500+ (MID) (K081268)

Substantially Equivalent To:

The Sonendo OmniClean Endotherapy System is substantially equivalent in intended use, principle of operation and technological characteristics to the Sonendo Endotherapy System (K130025), the EMS Piezon Master 700 (K093000) and the Sonic Air MM 1500+ (MID) (K081268).

Description of the Device Subject to Premarket Notification:

Indication for Use :.

The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 11 and 2nd molar teeth indicated for root canal therapy.

Page 1 of 3 Premarket Notification: K133752

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Technical Characteristics:

The Sonendo OmniClean Endotherapy System has similar physical and technical characteristics to the predicate devices. These characteristics are tabulated below:

Characteristics	SonendoOmniCleanEndotherapySystem (K133752)	SonendoEndotherapySystem (K130025)	EMS PiezonMaster 700(K093000)	Sonic Air MM1500 + (MID)(K081268)
Function	Preparation,cleaning andirrigation of rootcanals	Preparation,cleaning andirrigation of rootcanals	Various,includingpreparation,cleaning andirrigation of rootcanals	Preparation,cleaning andirrigation of rootcanals
Principle ofOperation	Generation ofhydroacoustic wavesand fluid motion.The tip of the deviceis placed inside thetooth duringcleaning.Hydroacoustics arecreated by the waterstream flowingthrough the guidetube and cominginto contact with thefluid inside the toothat the distal tip.The fluid stream isdispersed anddeflected by thedistal end plate ofthe tube creatinghydrodynamics(fluid motion)within the tooth.	Generation ofhydroacoustic wavesand fluid motion.The tip of the deviceis placed inside thetooth duringcleaning.Hydroacoustics arecreated by the waterstream flowingthrough the guidetube and cominginto contact with thefluid inside the toothat the distal tip.The fluid stream isdispersed anddeflected by thedistal end plate ofthe tube creatinghydrodynamics(fluid motion)within the tooth.	Generation ofhydroacousticwaves and fluidmotion	Generation ofhydroacousticwaves and fluidmotion
Treatment Site	Root canal	Root canal	Various,including Rootcanal	Root canal
Components	Control UnitIrrigation reservoirsFoot pedalHandpieceAccessories	Control UnitIrrigation reservoirsFoot pedalHandpieceAccessories	Control UnitIrrigationreservoirsFoot pedalHandpieceInstruments	HandpieceInstruments
Flow Rate	45 +/- 10 ml/min.	50-70 ml/min.	0-50 ml/min.	Unspecified.
Duration ofApplication	Leak test = 1minute.Treatment time = 7minutes and 45seconds.	Leak test = 1minute.Treatment time = 16minutes.	Unspecified.	Unspecified.
Irrigation Fluid	NaOCl	NaOCL	NaOCL	Water
	EDTA	Water	Water
	Water		Chlorhexidine
			Hydrogen
			peroxide
			Citric acid

Sonendo, Inc. Sonendo OmniClean Endotherapy System Page 2 of 3 Premarket Notification: K133752

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Performance Data:

All necessary performance testing has been conducted for the Sonendo OmniClean Endotherapy System to assure substantial equivalence to the predicate devices and to demonstrate the devices perform as intended. All testing was performed on test units representative of finished devices. Testing included:

Simulated Use ●
EMC and Electrical Safety .
Thermal Safety
Hydroacoustics .
Apical Extrusion and Pressure ●
. Cleaning

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Sonendo OmniClean Endotherapy System is determined by Sonendo, Inc., to be substantially equivalent to existing legally marketed devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60

Silver Spring, MD 20993-0002

Public Health Service

May 15, 2014

Sonendo, Incorporated Mr. Dan Miller Vice President of Regulatory, Clinical Affairs, and Quality Assurance 26061 Merit Circle, Suite 101 Laguna Hills, CA 92653

Re: K133752

Trade/Device Name: Sonendo OmniClean Endotherapy System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: April 15, 2014 Received: April 18, 2014

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.

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

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Page 2 - Mr. Miller

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 (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.

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/ResourcesforYou/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary|S|Bunner -S

Erin I. Keith, M.S. 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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Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K133752

Device Name: Sonendo OmniClean Endotherapy System

Indications for Use:

The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 181 and 2nd molar teeth indicated for root canal therapy.

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)

Sheena A. Green-S 2014.05.15 09:02:20 -04'00'

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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.