The Multiflex Tinnitus Technology™ is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.

The Multiflex Tinnitus Technology™ is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The ncating patients barrering from themnology™ must be done by a hearing professional participating in a Tinnitus Management Program.

Device Description

The Starkey Multiflex Tinnitus Technology™ provides the hearing care professional with an option to treat those patients suffering from tinnitus. It is a firmware functionality option embedded in the signal processing stage of a digital hearing aid. The Multiflex Tinnitus Technology™ firmware generates broadband white noise that periodically fluctuates in amplitude and frequency to provide relief for those suffering from timitus.

The Multiflex Tinnitus Technology™ functionalities and parameters are enabled and adjusted by a hearing care professional to meet the individual needs of the patient.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, study methodologies, or performance results for the Starkey Laboratories Multiflex Tinnitus Technology. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone performance study with detailed acceptance criteria and results.

Here's a breakdown of what can be extracted and what is missing:

The submission states:
"Starkey Laboratories has conducted a risk analysis and performed the necessary verification and validation activities to demonstrate that the design outputs meet the design inputs. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."

However, no specific acceptance criteria or quantitative performance data from these verification and validation activities are provided in the extracted text. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given input.

Regarding the other requested information:

A table of acceptance criteria and the reported device performance: Not available in the provided text. The document only generally states that testing was performed and confirmed the device meets design inputs for its intended use.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text. The 510(k) summary doesn't disclose details about sample sizes or data provenance for any testing.
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/available. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnoses). Since the device is a tinnitus masker generating sound, the "ground truth" would likely relate to objective sound characteristics or subjective patient feedback, though no details are provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/available. See point 3.
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 sound generator for tinnitus, not an AI-assisted diagnostic tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is a "firmware functionality option embedded in the signal processing stage of a digital hearing aid" that "generates broadband white noise." Its performance as a standalone algorithm would likely involve objective acoustic measurements (e.g., frequency response, amplitude stability, output levels) and potentially subjective patient feedback studies. However, no specific details of such standalone performance studies are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available. For a tinnitus masker, ground truth could involve objective acoustic properties of the generated sound, or validated patient-reported outcome measures for tinnitus relief. The document generically mentions "verification and validation activities" but doesn't specify the ground truth used.
The sample size for the training set: Not applicable/available. This sounds like an AI/machine learning term. While the device has "firmware functionality," the description doesn't suggest it's a machine learning algorithm that requires a "training set" in the typical sense. It seems to be a more deterministic signal generation process.
How the ground truth for the training set was established: Not applicable/available. See point 8.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, as well as general statements about risk analysis and verification/validation. It explicitly states: "The schedule of use is supported by an FDA consensus standard with amplitude/frequency fluctuation being supported by a number of research studies included in this submission." However, the details of these research studies, their methodologies, acceptance criteria, or quantitative results are not included in the extracted text.

Summary

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122876

Starkey Laboratories Multiflex Tinnitus Technology 510(k) Submission

OCT 31 2012

Section 7 - 510(k) Summary

Submission By:	Starkey Laboratories6600-6700 Washington Avenue So.Eden Prairie, MN. 55344Phone: 952-941-6401Fax: 952-828-9121
Contact:	Ken MeyerRegulatory ManagerStarkey World Headquarters6600-6700 Washington Avenue So.Eden Prairie, MN. 55344Phone: 952-947-4734Fax: 952-828-9121
Date Prepared:	July 20, 2012
Device Name:	Multiflex Tinnitus TechnologyTM
Device Trade/Proprietary Name:	Multiflex Tinnitus TechnologyTM
Device CommonName:	Tinnitus Masker
Device Class:	Class II
Classification Name: 21 CFR 874.3400 Tinnitus Masker
Classification Panel: Ophthalmic and Ear, Nose, and Throat Division
Product Code:	KLW
Predicate Device:	K110932, GN Resound Tinnitus Sound Generator Module

Device Description

Section 7 510(k) Summary

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122.876

Tinnitus Technology™ firmware generates broadband white noise that periodically fluctuates in amplitude and frequency to provide relief for those suffering from timitus.

The Multiflex Tinnitus Technology™ functionalities and parameters are enabled and adjusted by a hearing care professional to meet the individual needs of the patient.

Intended Use

The Multiflex Tinnitus Technology™ is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders.

The fitting of the Multiflex Tinnitus Technology™ must be done by a hearing professional participating in a tinnitus management program.

Technological Characteristics Comparison

The Starkey Multiflex Tinnitus Technology uses the same basic technology used by the predicate device. It shares the following similarities to the predicate devices:

The Starkey Multiflex Tinnitus Technology has a similar platform, similar . functionality, similar color of sound, similar number of programs, similar circuit type, similar overall stimulus level, similar maximum output characteristics, similar volume/level control approach, and a similar power source as the predicate device.
The technological characteristics of the Starkey Multiflex Tinnitus Technology that differ from the predicate device are:
Schedule of use .
Amplitude/frequency fluctuation .

The schedule of use is supported by an FDA consensus standard with amplitude/frequency fluctuation being supported by a number of research studies included in this submission.

The methodology of such implementation in the Multiflex Tinnitus Technology™ introduces no new energies, frequencies or levels of such that may introduce risk or effectiveness concerns.

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K122876

Starkey Laboratories Multiflex Tinnitus Technology 510(k) Submission

Performance Data

Starkey Laboratories has conducted a risk analysis and performed the necessary verification and validation activities to demonstrate that the design outputs meet the design inputs. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.

Conclusions

Based on the similar indications for use, technical characteristics and results from performance testing, Starkey Laboratories considers the Starkey Multiflex Tinnitus Technology substantially equivalent to the GN ReSound Tinnitus Sound Generator under K110932.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

OCT 31 2012

Starkley Laboratories c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K122876

Trade/Device Name: Multiflex Tinnitus TechnologyTM Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: September 18, 2012 Received: September 19, 2012

Dear Mr. Job:

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 - Mr. Mark Job

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eakm for

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

Enclosure

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Section 5 Indications for Use

Section 5. Indications for Use

510(k) Number: Reference Document K12xxxx

Device Name: Multiflex Tinnitus Technology™

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K122876

Prescription Use (Per 21 CFR 801.109)

Page 1 of 1 -

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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.