The Levo 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 Levo System is designed to assist the qualified health care professional in evaluating the patient's tinnitus and preparing a customized sound therapy to be delivered to the patient during treatment. The Levo System provides idiopathic tinnitus masking treatment based upon sound stimulation during sleeping or waking hours. The Levo System consists of two proprietary software applications that are pre-installed on commercially available, off-the shelf consumer electronics (i.e., Apple® iPad® or iPad Air™ and iPod®. Custom-fit ear buds are provided with the device. The Levo System uses amplitude modulated tinnitus pitch matched tones, narrow-band noise centered at the tinnitus frequency, and broad-band noise.

AI/ML Overview

The provided text describes a 510(k) submission for the Otoharmonics® Levo® System, a tinnitus masker device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for clinical efficacy.

Therefore, many of the requested details about acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided because the regulatory pathway for this device, at this stage, relies on demonstrating comparable technical and safety characteristics to a legally marketed predicate device.

Here's an attempt to extract and infer information based on the provided text, addressing each point as much as possible:

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

The document does not present a table of specific clinical acceptance criteria for relief of tinnitus symptoms or quantifiable performance metrics in that regard. Instead, it focuses on demonstrating that the Levo System meets safety and technical performance requirements comparable to its predicate device.

Acceptance Criteria (Inferred from regulatory guidance/testing)	Reported Device Performance
Safety:
Biocompatibility (ISO 10993 standards)	Demonstrated per ISO 10993-1, ISO 10993-5, and ISO 10993-10 for limited duration contact with intact skin.
Electrical Safety (AAMI/ANSI ES 60601-1)	Meets the safety performance requirements.
Electromagnetic Compatibility (IEC 60601-1-2)	Meets the electromagnetic compatibility requirements.
Risk Management	Potential risks identified, evaluated, and determined to be acceptable or addressed with risk control measures.
Technical Performance:
Software Verification & Validation (As intended/specifications)	Demonstrated that the software performs as intended and in accordance with specifications.
Acoustic Output Specifications (Various tests)	The acoustic outputs of the device meet specifications, including testing for: - Frequency response of ear buds, patient device, and software - Amplitude of generated output - Software/firmware performance - Amplitude modulation of signal - Independent volume control of left and right channel.
General Functionality (Substantial Equivalence):
Intended Use/Indications for Use (Same as predicate)	Same intended uses and similar indications as the predicate.
Technological Characteristics (Similar to predicate)	Very similar technological characteristics in device design and specifications. Generates same general types of sounds and amplitude modulated tones.
Principles of Operation (Similar to predicate)	Similar principles of operation as the predicate device.

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

The document describes nonclinical testing for validation and verification, primarily focusing on engineering and software performance. It does not mention a "test set" in the context of patient data, clinical trials, or clinical endpoints for the device's efficacy in relieving tinnitus symptoms. Therefore, information about sample size, data provenance, and study type (retrospective/prospective) for a clinical test set is not provided.

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)

Not applicable. The document does not describe a clinical test set requiring expert-established ground truth for performance evaluation of tinnitus relief. The "ground truth" here is primarily against pre-defined engineering specifications and regulatory standards.

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

Not applicable, as no clinical test set for performance evaluation is described.

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

Not applicable. This device is a tinnitus masker, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" interpreting data. An MRMC study is not relevant to the described device and its regulatory submission.

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

The primary performance studies described are standalone technical and software verification/validation tests. These confirm that:

The software performs as intended and in accordance with specifications.
The acoustic outputs meet specifications (frequency response, amplitude, modulation, volume control).
Biocompatibility, electrical safety, and electromagnetic compatibility standards are met.

The device itself is designed to be used with the advice of a physician, audiologist or other hearing healthcare professional, who prepares the customized sound therapy. So, while the underlying technical components are tested in a standalone manner, the overall system functions as a tool within a human-guided tinnitus management program.

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

For the nonclinical performance testing, the "ground truth" used are:

Engineering specifications: For frequency response, amplitude, software/firmware performance, etc.
Regulatory standards: Such as ISO 10993 for biocompatibility, AAMI/ANSI ES 60601-1 for electrical safety, and IEC 60601-1-2 for electromagnetic compatibility.
Predicate device characteristics: To demonstrate substantial equivalence in intended use, technological characteristics, and principles of operation.

No clinical outcomes data or expert consensus on patient response to treatment is detailed in this 510(k) summary, as it falls under demonstrating substantial equivalence, not clinical efficacy through new trials.

8. The sample size for the training set

Not applicable. The document does not describe any machine learning or AI models that would require a "training set" in the conventional sense. The software's functionality is based on pre-defined algorithms for generating sound therapies, not learning from data.

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

Not applicable, as no training set for an AI/ML model is mentioned.

Summary

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JUL 1 8 2014 510(k) SUMMARY Otoharmonics® Levo® System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Otoharmonics Corp 411 SW 6th Ave Portland, Oregon 97204 Phone: 503.336.9906

Contact Person: Michael Baker, President/CEO

Date Prepared: July 11, 2014

Name of Device

Levo System

Common or Usual Name/Classification Name, Classification

Tinnitus Masker Device, 21 CFR 874.3400 (Product Code KLW), Class II

Predicate Devices

SoundCure, Inc.'s Serenade Tinnitus Treatment System (K111293)

Intended Use / Indications for Use

Device Description

The Levo System is designed to assist the qualified health care professional in evaluating the patient's tinnitus and preparing a customized sound therapy to be delivered to the patient during treatment. The Levo System provides idiopathic tinnitus masking treatment based upon sound stimulation during sleeping or waking hours. The Levo System consists of two proprietary software applications that are pre-installed on commercially available, off-the- shelf consumer electronics (i.e., Apple® iPad® or iPad Air™ and iPod®. Custom-fit ear buds are provided with the device. The Levo System uses amplitude modulated tinnitus pitch matched tones, narrow-band noise centered at the tinnitus frequency, and broad-band noise.

Technological Characteristics

The Levo System presents very similar technological characteristics as the predicate Serenade Tinnitus Treatment System in device design and specifications. Both devices are designed to assist in the evaluation of a patient's tinnitus, and can be used by the healthcare professional to prepare a customized sound therapy for each patient. Both devices include software components that operate on designated hardware platforms, although the specific hardware used are not the same (i.e., offthe-shelf consumer electronics versus customized hardware). In addition, the Levo System transmits data wirelessly between the devices, whereas the predicate device

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utilizes a USB cord. However, these differences do not raise any new types of safety or effectiveness questions for the Levo device. Robust risk analysis and verification and validation testing further support the substantial equivalence of the devices. In addition, for both devices, the customized sound therapy is delivered to patients through a hand-held audio device. The devices both generate sounds that can be confiqured from broad band to narrow band, and provide for amplitude modulated tinnitus pitch matched tones. The Levo System can be used to generate the exact same type of amplitude modulated sounds as the predicate device. Therefore, the similar technological characteristics of the devices support substantial equivalence.

Performance Data

Nonclinical testing was conducted to validate the performance of the Levo System and ensure the device performs as intended and meets the design specifications. consistent with FDA's "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices" (2005). The biocompatibility of the patient-contacting materials of the Levo System has been demonstrated per ISO 10993-1, ISO 10993-5, and ISO 10993-10 for a device with limited duration of contact with intact skin.

Consistent with FDA's guidance document, the Levo System meets the safety performance requirements of AAMI/ANSI ES 60601-1 and electromagnetic compatibility requirements of IEC 60601-1-2.

Software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. The potential risks of the Levo System have been identified and evaluated, and the risks were determined to be acceptable, or have been addressed with risk control measures. Performance testing further demonstrated that the acoustic outputs of the device meet specifications, including the following testing:

· Frequency response of the ear buds, patient device, and software
· Amplitude of generated output
· Software/firmware performance
· Amplitude modulation of signal
· Independent volume control of left and right channel of device

Therefore, in all instances of performance testing, the Levo System functioned as intended.

Substantial Equivalence

The Levo System is as safe and effective as the SoundCure predicate device. The Levo System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The Levo System provides the same general types of sounds and amplitude modulated tones as the predicate device. Although the Levo System and the predicate device operate with different patient device hardware, data transmission (i.e., wireless versus USB cable), and output ranges, these minor technological differences between the Levo System and its predicate device do not raise any new issues of safety or effectiveness. Thus, the Levo System is substantially equivalent to the SoundCure

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predicate. Further details regarding the comparison of the device and the predicate are providing in the following table.

Trade Name	Otoharmonics Levo System	SoundCure Serenade TinnitusTreatment System (K111293)
Indicationsfor use	The Levo System is indicated for use inthe temporary relief of tinnitussymptoms. The device is a tool togenerate customized sounds to relievepatients suffering from tinnitus and canbe used in a tinnitus managementprogram. The target population is adults(18 years or older). This is a medicaldevice and should only be used with theadvice of a physician, audiologist orother hearing healthcare professional.	The SoundCure Serenade TinnitusTreatment System is indicated for use inthe temporary relief of tinnitus symptoms.The device is a tool to generatecustomized sounds to relieve patientssuffering from tinnitus and can be used ina tinnitus management program. Thetarget population is adults (18 years orolder).This is a medical device and should onlybe used with the advice of a physician,audiologist or other hearing healthcareprofessional.
PatientMedium	Hand-held audio device (iPod touch®)for use with custom headphones	Hand-held audio device (Serenadepatient device) with headphones
Components	Levo Manager software supplied pre-installed on iPad® or iPad Air ™Levo Patient software supplied pre-installed on iPod touch®Ear budsAccessories (standard Apple® chargerwith Apple® device)	Serenade Treatment Software (to beused with user's commercially availablecomputer)Serenade patient device with softwarepre-installedEarphonesAccessories (power supply, power cord,USB cable)
Sounds	Sounds customized to the patient byqualified health care professional.From 1 to ten (10) combinations of thefollowing sounds:• Pure Tone• White Noises• Narrow Band Noises (bandwidthselectable by HCP)Includes the ability to create sinusoidalamplitude modulated (SAM) tones.	Sounds customized to the patient byqualified health care professional.Individually patient selectable from thefollowing sounds:• Sinusoidal amplitude modulated(SAM) tones (S-Tones) (choice of 2predefined by HCP)• White Noises• Band Noises
DataLogging	Data logging of patient use	Data logging of patient use
VolumeControl	Individual volume control per ear	Individual volume control per ear
Features inSleep	Help to Sleep (optional) - Music playedto help patient relax	SleepAssist technology - Sleep ModeTimer to help the patient fall asleep
MaximumOutput	85 dB SPL	92 dB SPL
OutputFrequency	100Hz - 16KHz	1 kHz to 14 kHz
Power	Rechargeable lithium-Ion (Li-Ion)Battery, external power supply (100-250VAC to 5V DC) with power cord forrecharging. (Battery and chargerprovided by Apple for Apple® devices)	Rechargeable lithium-Ion (Li-Ion) Battery,external power supply (100-250VAC to5V DC) with power cord for recharging.

Otoharmonics and Levo are registered trademarks of Otoharmonics Corporation.

Apple, iPod touch and iPad are registered trademarks of Apple Inc.

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Conclusions

In conclusion, the Levo System is substantially equivalent to the SoundCure predicate device and software verification and validation testing further demonstrate that the software performs as intended and in accordance with specifications.

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Public Health Service

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

July 18, 2014

. .

Otoharmonics c/o Ms. Yarmela Pavlovic Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103

Re: K140845

Trade Name: Otoharmonics LEVO Tinnitus Masking Software Device Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II, Product Code: KLW Dated: June 17, 2014 Received: June 17, 2014

Dear Ms. Pavlovic:

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. Yarmela Pavlovic

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 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" (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/ReportalProblem/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

LEVO Tinnitus Masking Software Device

Indications for Use (Describe)

The LEVO Tinnitus Masking Device 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Ting Zhang -S 2014.07.14 08:58:36 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.