The SoundCure® Serenade® Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).

This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Device Description

The SoundCure® Serenade® Tinnitus Treatment System (Serenade System) is a personalized sound therapy system designed specifically to evaluate a patient's tinnitus, to create customized audio stimulus, and to deliver and monitor/data log the audio stimulus. The Serenade System is intended to provide relief from the debilitating effects of tinnitus through the use of a hand-held customized digital audio device (Serenade Patient Device) that generates sound therapy/masking. The Serenade System uses modulated tinnitus pitch matched tones (S-Tones) and narrow-band noise centered at the tinnitus frequency and provides broad-band noise. The Serenade System consists of the following components: Serenade Treatment Software, Earphones, Serenade Patient Device as well as the following Accessories: power supply, power cord and USB cable.

The Serenade System with Remote Programming modification is limited to changes to components of the Serenade Treatment Software (Web, PC & addition of Communications Software Component on patient's home computer), modifications to user interface and updates to labeling (Professional, Patient and Patient Remote Connection Quick Start Guide). The Serenade Patient Device and accessories are unchanged.

AI/ML Overview

The provided document is a 510(k) summary for the SoundCure® Serenade® Tinnitus Treatment System. It details the device's characteristics, comparison to a predicate device, and performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets for clinical performance and corresponding "reported device performance." Instead, the clinical study was designed to demonstrate "substantial equivalence" of the remote programming model to the in-office programming model, rather than achieving specific performance metrics against a defined standard.

The general acceptance criterion for the clinical study can be inferred as:

Acceptance Criterion: The remote programming model for the Serenade System should not introduce new safety concerns and should result in successfully programmed devices, with parameters not significantly differing from the known test-retest variability of in-person programming.
Reported Device Performance: "The results from this study demonstrated that the SoundCure Serenade Tinnitus Treatment System can be successfully programmed remotely without introducing new safety concerns."

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

Sample Size: The document states "a non-significant risk, prospective site study involving patients with confirmed tinnitus." However, the exact number of patients (sample size) used in the clinical study for the remote programming evaluation is not explicitly stated in the provided text.
Data Provenance: "prospective site study." The country of origin of the data is not specified.

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

The document does not describe the use of "experts" to establish a ground truth for the test set in the traditional sense of diagnostic accuracy studies (e.g., radiologists interpreting images). Instead, the clinical study focused on comparing programming parameters between in-office and remote methods.

The study involved "hearing healthcare professionals (HHP)" who performed the programming. Their qualifications are generally implied by the requirement that the device "should only be used with the advice of a physician, audiologist or other hearing healthcare professional," but specific details on their experience or number for establishing a ground truth are not provided.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not describe an adjudication method for the test set as it would pertain to resolving discrepancies in expert interpretations. The study's focus was on the equivalence of programming methods, not on diagnostic accuracy requiring adjudication of interpretations.

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

No MRMC study was performed in the context of improving human reader performance with or without AI assistance.
The device (SoundCure Serenade Tinnitus Treatment System) is a sound therapy system for tinnitus and not an AI-based diagnostic tool that would typically involve human readers interpreting AI output. The clinical study focused on the equivalence of remote programming functionality.

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

The device is a "personalized sound therapy system" that involves the assessment and programming by "hearing healthcare professionals." The "Serenade Patient Device" generates sound, but its customization and setup require human-in-the-loop interaction from an HHP. The clinical study specifically evaluated the remote programming model which still involves a human (HHP) accessing the patient's PC for programming. Therefore, a standalone (algorithm only) performance study, without human interaction, does not appear to have been performed or would be relevant for this type of device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document mentions that the purpose of the study was to determine if "Differences between parameters obtained from in-person (local) evaluation or remote evaluation should not differ from the known test-retest variability with in-person (local) testing." This implies that the "ground truth" or reference for comparison were parameters obtained through established in-person (local) evaluation methods, and the variability known from those methods. It is not an expert consensus on a diagnosis, pathology, or direct outcomes data in the usual sense for a diagnostic device.

8. The Sample Size for the Training Set

The document focuses on a clinical study for the remote programming model's equivalence to the in-office model. There is no mention of a separate training set as would be used for training a machine learning algorithm. The "Serenade System" itself (the predicate device) was previously cleared, suggesting its underlying programming logic was developed, but the details of that development (e.g., training data) are not part of this 510(k) summary for a modification.

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

As no training set is discussed or implied for the specific modification described in the 510(k), this information is not provided.

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

April 13. 2015

Ms. Diana DeGregorio Regulatory Affairs Consultant SoundCure, Inc. 560 S. Winchester Blvd, Suite 500 San Jose, CA 95128

Re: K150065

Trade/Device Name: SoundCure Serenade Tinnitus Treatment System Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: January 12, 2015 Received: January 13, 2015

Dear Ms. DeGregorio:

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

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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 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 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,

Kesia Y. Alexander -A

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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Indications for Use Statement

150065 510(k) Number (if known): K_

Device Name: SoundCure® Serenade®Tinnitus Treatment System

Indications for Use:

This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Prescription Use	X
Or	Over-The-Counter Use

(per 21 CFR 801.109)

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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510(k) Summary

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

l. SUBMITTER

SoundCure, Inc. 560 S. Winchester Blvd Suite 500 San Jose, CA 95128 Phone: (408) 938-5745 Fax: (408) 938-5746

Contact Person: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 ddegregorio@linceconsulting.com

Alternate Contact: Nancy Lincé, RAC Lincé Consulting Clinical and Regulatory Affairs Consultant (650) 759-6186 nlince@linceconsulting.com

Date Prepared January 9, 2015

II. DEVICE

Trade Name: Common Name: Classification Name: Classification: Product Code: Device Class:

SoundCure® Serenade® Tinnitus Treatment System Tinnitus Masker Tinnitus Masker 21 CFR §874.3400 KLW Class II

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lll. PREDICATE

SoundCure, Inc. SoundCure® Serenade® Tinnitus Treatment System (K111293) This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Serenade System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).

This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

OF TECHNOLOGICAL CHARACTERISTICS VI. COMPARISON WITH THE PREDICATE DEVICE

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The Serenade System has similar features as compared to the predicate devices in the table below.

ManufacturerDevice Name	SoundCure, Inc.SoundCure® Serenade® TinnitusTreatment System	SoundCure, Inc.SoundCure® Serenade® TinnitusTreatment System
510(k) Number	K111293	Remote Programming Modification
Indications for Use	The SoundCure™ Serenade™Tinnitus Treatment System isindicated for use in the temporaryrelief of tinnitus symptoms. Thedevice is a tool to generatecustomized sounds to relievepatients suffering from tinnitus andcan be used in a tinnitusmanagement program. The targetpopulation is adults (18 years orolder).This is a medical device andshould only be used with theadvice of a physician, audiologistor other hearing healthcareprofessional.	Same
Product Code	KLWTinnitus Masker,21CFR874.3400 Class II	Same
Common Name	Tinnitus Masker	Same
DispensingProfessional	Hearing Healthcare Professional	Same
Programming Location	In office	In office or Remotely
Target Population	Adults with Tinnitus	Same
Use Location	May be used anywhere	Same
Physical Description	Handheld device with soundsdelivered through earphones	Same
Mechanism of Action	Uses noise that can be configuredfrom broad band to narrow band,and pure tones customized to thepatientStimulus can be amplitudemodulatedLevel of sound can be adjusted bya user volume controlIndependent volume parametersper earStimulus designed to be placed inthe background and ignored	Same
Maximum OutputCharacteristics	Maximum output fixed at 92dBSPLOutput Frequency Response:1kHz to 14 kHz	Same
ManufacturerDevice Name	SoundCure, Inc.SoundCure® Serenade® TinnitusTreatment System	SoundCure, Inc.SoundCure® Serenade® TinnitusTreatment System
510(k) Number	K111293	Remote Programming Modification
Target Anatomy	Ear	Same
Design Features	Patient Device Sound Generatorwith frequency shaped soundsSleep Mode Timer (60 min timer toshut-off when button is pressed)Amplitude modulationSounds customized to the patientHandheld device with earphones4 sound programs / tracks(memory for up to 8)Data logging of patient useIndividual volume control per ear	Same
Software ArchitecturalDesign	Serenade Patient Device(Embedded Software), hearinghealthcare professional's computer(PC Software), and SoundCureServer (Web Software)	Serenade Patient Device (EmbeddedSoftware), hearing healthcareprofessional's computer (PC Software),patient's home computer(Communications Software),SoundCure Server (Web Software)
Patient ContactMaterials	Silicone earphones	Same
Biocompatible forIntended Use	Yes	Same
Training Course	Specific Training course for hearinghealthcare professionalsIn office support	Specific Training course for hearinghealthcare professionalsSupplemental Training course (hearinghealthcare professionals) for remoteprogramming.In office support
Power	Rechargeable Lithium-Ion (Li-Ion)BatterySerenade System also includes anexternal power supply (100-250VAC to 5V DC) with powercord for recharging	Same
Meets ApplicableIEC60601-1 testing	Yes	Same

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The technological characteristics and principals of operation of the Serenade System are substantially equivalent to the named predicate device.

VII. PERFORMANCE DATA

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Performance Testing was performed in accordance to Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices dated November 8, 2005. The following performance testing was conducted on the Serenade System to support a determination of substantial equivalence to the predicate device.

· System Output Performance Testing • Electrical Safety & Electromagnetic
Compatibility Testing • Packaging Validation Testing
- Software Verification and Validation

Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the Serenade System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the Serenade System is substantially equivalent to the named predicate.

Clinical Performance Testing

A clinical study was conducted to demonstrate that the SoundCure Serenade Tinnitus Treatment System using the remote programming model is substantially equivalent to the Serenade Device using the current programming model (in-office). The study was a non-significant risk, prospective site study involving patients with confirmed tinnitus who did not have any previous experience with the Serenade System. Each patient underwent in-office and remote device programming. The purpose of the study was to determine if the patient labeling and remote HHP instructions and process using the patient's PC as an access port for HHP performed matching and device programming, resulted in a successfully programmed device. Differences between parameters obtained from in-person (local) evaluation or remote evaluation should not differ from the known test-retest variability with inperson (local) testing. The results from this study demonstrated that the SoundCure Serenade Tinnitus Treatment System can be successfully programmed remotely without introducing new safety concerns.

VIII. CONCLUSIONS

The Serenade System has been carefully compared to a legally marketed predicate device with respect to intended use/indications for use, technological characteristics, anatomical sites, performance, safety characteristics, and labeling. In addition, nonclinical and clinical testing was conducted to verify and validate the performance of the device and ensure the Serenade System performs as intended and meets the design specifications. The comparison, non-clinical and clinical performance testing

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results demonstrate that the device is substantially equivalent to the predicate device for its intended use and does not raise new issues of safety or effectiveness.

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.