REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Device Description

KW EAR LAB'S REVE134 consists of software installed in PC (desktop or laptop computer). REVE134 is fitted to the patient by the hearing healthcare professional. The software enables qualified professional to create customized sounds with specific frequency range for sound therapy/masking. REVE134 software can generate either modulated white noise (233~12912 Hz) or modulated narrow band noises or tones with specific frequency range. One narrow band noise has a frequency range of approximately 1/3 octave.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for a device called REVE134, a Tinnitus Masker. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or statistical acceptance criteria for the device itself.

Based on the provided text, here's an analysis regarding acceptance criteria and performance studies:

Key Takeaway: The submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than providing comparative effectiveness studies or detailed quantitative performance metrics of REVE134 itself. The "Performance Data" section states that the software "functioned properly as intended and the performance observed was as expected" based on verification and validation against software and risk management standards, but no specific performance metrics or acceptance criteria are detailed.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, and expert involvement are not explicitly provided or are not applicable in the context of this 510(k) submission, which focuses on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, explicit numerical acceptance criteria and a table of reported device performance metrics are NOT presented. The submission states: "KW EAR LAB's REVE134 software installed and embedded in PC has been verified and validated according to relevant standards for medical device software and risk management procedure (Fig. 1). In all verification and validation process, KW Ear lab's REVE134 functioned properly as intended and the performance observed was as expected."

This indicates that while internal verification and validation were performed against standards, the specific quantitative "acceptance criteria" for clinical performance (e.g., reduction in tinnitus perception, user satisfaction scores) and the measured performance against those criteria are not detailed in this regulatory filing.

Acceptance Criteria (Not Explicitly Stated in Document)	Reported Device Performance (Not Explicitly Stated in Document)
The document does not specify quantitative clinical performance acceptance criteria (e.g., specific thresholds for tinnitus reduction, sound generation accuracy beyond "proper functioning").	The document states the device "functioned properly as intended and the performance observed was as expected" based on internal verification and validation against IEC 62304 and ISO 14971:2007. No specific quantitative performance data (e.g., sound output precision, masking effectiveness scores) is provided.

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

Not applicable for a clinical performance test set, as no such clinical test set is described. The "Performance Data" section refers to software verification and validation against standards, which typically involves testing and debugging, but not a "test set" in the sense of patient data for clinical performance evaluation. The data provenance is also not relevant here as clinical data is not presented.

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

Not applicable. Since no clinical performance test set with a ground truth is described, there's no mention of experts establishing ground truth. The submission focuses on software engineering and risk management standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is a Tinnitus Masker, a sound-generating software, not an AI-powered diagnostic or assistive tool for human readers (like in medical imaging). Therefore, an MRMC study or AI-assistance evaluation is not relevant to this device's function or the information provided.

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

Partially relevant, but not in the context of clinical "performance." The device is essentially "algorithm only" in generating sounds. However, the evaluation described is one of functional verification and validation against software standards (IEC 62304) and risk management (ISO 14971), not a "standalone performance" study measuring efficacy of tinnitus relief in patients or comparing it to a control. The document states: "KW EAR LAB's REVE134 software installed and embedded in PC has been verified and validated according to relevant standards for medical device software and risk management procedure (Fig. 1). In all verification and validation process, KW Ear lab's REVE134 functioned properly as intended and the performance observed was as expected."

7. The Type of Ground Truth Used

Not applicable in a clinical sense. For a device like a Tinnitus Masker, clinical ground truth would typically refer to objective measures of tinnitus (if available) or patient-reported outcomes. However, the performance data provided in the document focuses on internal software verification and validation, where "ground truth" relates to the software meeting its functional specifications and risk management requirements. No clinical ground truth on patient outcomes is presented.

8. The Sample Size for the Training Set

Not applicable. This device is not described as using machine learning or needing a "training set" in the context of AI model development. It's software that generates sounds based on pre-programmed parameters.

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

Not applicable. As no training set for a machine learning model is mentioned, there's no ground truth established for it.

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 stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

October 8, 2015

KW Ear Lab, Inc. Mr. Sungwoo Cho Vice President/General Counsel 18655 South Bishop Ave Carson, CA 90746

Re: K151719

Trade/Device Name: Reve134 Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: June 25, 2015 Received: July 1, 2015

Dear Mr. Cho:

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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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 devicerelated 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 Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit 5 Indications for Use Statement

K151719 510(k) number (if known):

Device Name: REVE134

Indications for Use:

REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing timitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 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)

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Exhibit 6 510(k) Summary

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510(k) Summary (REVE134)

Submitter:	KW EAR LAB, INC.18655 South Bishop Ave, Carson, CA 90746Phone: (310)-747-1390
Contact Person:	Sungwoo ChoKW EAR LAB, INC.18655 South Bishop Ave, Carson, CA 90746Phone: (310)-747-1390
Date Prepared:	May 30, 2015
Device Name:	REVE134
Device Class:	Class II
Classification Name:	Tinnitus Masker
Classification Regulation:	21 C.F.R. 874.3400
Product Code	KLW
Predicate Devices:	K133308 Tinnitus SoundSupport, OticonK110932 Tinnitus Sound Generator, GN Resound
Intended Use / Indication for Use:	REVE134 is a sound generating software used in a TinnitusManagement Program designed to provide temporary relief forpeople experiencing tinnitus symptoms. It is intendedprimarily for adults over 18 years of age, but may also be usedfor children 5 years of age or older. REVE134 is for use byhearing healthcare professionals who are familiar with theevaluation and treatment of tinnitus and hearing losses. Ahearing healthcare professional should recommend that apatient listen to the REVE134 signal for 30 minutes twice aday at the barely audible level (minimally detectable level).
Technological Characteristics:	KW EAR LAB'S REVE134 consists of software installed in PC(desktop or laptop computer). REVE134 is fitted to the patient bythe hearing healthcare professional. The software enables qualifiedprofessional to create customized sounds with specific frequencyrange for sound therapy/masking. REVE134 software can generateeither modulated white noise (233~12912 Hz) or modulated narrow

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band noises or tones with specific frequency range. One narrow band noise has a frequency range of approximately 1/3 octave.

Performance Data:

KW EAR LAB's REVE134 software installed and embedded in PC has been verified and validated according to relevant standards for medical device software and risk management procedure (Fig. 1). In all verification and validation process, KW Ear lab's REVE134 functioned properly as intended and the performance observed was as expected.

Fig. 1

Standard No.	Standard Title
IEC 62304	Medical device software – Software life-cycleprocesses
ISO14971:2007	Medical devices- Application of riskmanagement to medical devices

Substantial Equivalence:

KW EAR LAB REVE134 is as safe and effective as Oticon's Tinnitus SoundSupport (K133308) and GN Resound's Tinntius Sound Generator (K110932). As shown in the table below, KW Ear lab's REVE134, Oticon's Tinnitus SoundSupport (K133308), and GN Resound's Tinntius Sound Generator (K110932) have the same intended use and similar indications, technological characteristics, and principles of operation. Minor technological differences do not present any new issues of safety or effectiveness. Thus, KW Ear lab's REVE134 is substantially equivalent to Oticon's Tinnitus SoundSupport (K133308), and GN Resound's Tinntius Sound Generator (K110932).

Comparison Table:

KW Ear lab Inc. REVE134

Substantial Equivalent Chart

Device	New	Predicate	Predicate
Manufacturer	KW Ear lab	Oticon	GN Resound
Name	REVE134	Tinnitus SoundSupport	Tinnitus Sound Generator
510(K) No.		K133308	K110932
Indicationfor Use	REVE134 is a tool togenerate sounds to be usedin a Tinnitus ManagementProgram to relieve patientssuffering from tinnitus.	Tinnitus SoundSupport is atool intended to generatesounds to provide temporaryrelief to patients sufferingfrom tinnitus as part of a	The Tinnitus SoundGenerator is a tool togenerate sounds to be usedin a Tinnitus ManagementProgram to relieve patients
	The target population isprimarily the adultpopulation over 18 years ofage. This product may alsobe used with children 5 yearsof age or older.REVE134 is targeted forhealthcare professionals who arefamiliar with the evaluationand treatment of tinnitus andhearing losses. A hearinghealthcare professionalshould recommend for apatient to listen to theREVE134 signal for 30minutes twice a day at thebarely audible level(minimally detectable level).A default starting level ofREVE134 is 54 dBr. Ahearing healthcareprofessional needs to adjustthis default value of '54 dBr'into patient's barely audiblelevel.	tinnitus managementprogram.The target population is theadult population (>18yrs).Tinnitus SoundSupport istargeted for licensed hearingprofessionals(audiologists, hearing aidspecialists, orotolaryngologists) who arefamiliar with the evaluationand treatment of tinnitus andhearing losses.The fitting of TinnitusSoundSupport must be doneby a hearing care professionalparticipating in a tinnitusmanagement program.	suffering from tinnitus.The target population isprimarily the adultpopulation over 18 years ofage. This product may alsobe used with children 5years of age or older.The Tinnitus SoundGenerator Module istargeted for healthcareprofessionals, which aretreating patients sufferingfrom tinnitus, as well asconventional disorders.
UserPopulation	Primarily adult population(>18yrs), can be used forpatients >5yrs	Adult population (>18yrs)	Primarily adult population(>18yrs), can be used forpatients >5yrs
Schedule of Use	All day	All day	All day in all environments
Mechanism	Volume is set by HCP andcan be adjusted by patients,when in use. Default levelfixed.Amplitude modulation noiseand frequency modulationpure tone	Volume is set by HCP and canbe adjusted by patients, whenin use. Default level fixed.Amplitude modulation andsteady noise.	Volume is set by HCP andcan be adjusted by patients,when in use. Default levelfixed.Amplitude modulation andsteady noise.
TechnologicalCharacteristics	Software module embeddedinto a digital hearinginstrument platform. Soundfiles generated by theREVE134 can be used onlyin a digital hearinginstrument platform whichprovides MP3 codec (e.g.,	Software module embeddedinto a digital hearinginstrument platform	Software module embeddedinto a digital hearinginstrument platform

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Regulation Number and Section

§ 874.3400 Tinnitus masker.

(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.