The Tinnitus Phase-Out consists of a personalized sound recorded onto a patient treatment device. The recorded sound is equivalent to that generated by the Tinnitus Rx. The treatment regimen for the Phase-Out is identical to that of the Rx. The only difference is the use of a patient treatment device instead of a customized CD.

AI/ML Overview

This document is a 510(k) summary for the Tinnitus Phase-Out device, which is a tinnitus masker. The core claim is substantial equivalence to a predicate device, Tinnitus Rx (K030791). The document describes the device, its intended use, and the performance testing conducted to support the substantial equivalence claim.

Here's an analysis of the provided text with respect to your questions:

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

Based on the provided text, the primary "acceptance criteria" is demonstrating substantial equivalence to the predicate device, Tinnitus Rx. The device performance reported is audio equivalence and meeting specific certifications/guidances.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence to Tinnitus Rx (K030791)	- Device generates sound equivalent to Tinnitus Rx
UL electrical certification	Met
FDA Guidance: Special 510(k)s: The New 510(k) Paradigm	Met
Class II Special Control Guidance, 21 CFR 874.3400(b)	Met
Conformance to the EU Medical Device Directive	Met

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 mentions "bench testing demonstrating audio equivalence." However, it does not specify the sample size used for this bench testing, nor does it provide details about the data provenance (e.g., country of origin, retrospective/prospective). This testing appears to be focused on the technical characteristics of the sound generated by the device, rather than patient data.

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)

The document does not describe any expert-based ground truth establishment for a test set. The "audio equivalence" appears to be based on technical measurements, not human perception or clinical outcomes evaluated by experts.

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

No adjudication method is mentioned as there is no indication of a test set involving human assessment or expert review.

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 such MRMC study was performed or described. The Tinnitus Phase-Out is a Tinnitus Masker, not an AI diagnostic or assistance tool for human readers.

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

The device is a Tinnitus Masker. The "standalone performance" is implicitly its ability to generate an "equivalent" sound to the predicate device for temporary relief of tinnitus symptoms. The bench testing focused on this technical equivalence. There's no "algorithm only" performance study in the context of a typical AI/ML medical device.

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

For the "audio equivalence" testing, the ground truth is the sound generated by the predicate device, Tinnitus Rx. The new device's sound production is compared directly to this existing, cleared device. There is no mention of clinical outcomes data, pathology, or expert consensus serving as ground truth for this technical performance claim.

8. The sample size for the training set

This is not applicable. The Tinnitus Phase-Out is a sound-generating device, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above.

Summary

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1 6 2008

Attachment 5

510(k) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes Timitus Control. Inc.'s summary for the Tinnitus Phase-Out.

SUBMITTER'S NAME ADDRESS:

CONTACT PERSON TELEPHONE NUMBER FAX NUMBER: DATE OF SUBMISSION

Tinnitus Control, Inc. 66 East 80th Street, Suite 1 A New York, New York 10021 _ Calvin Yee 212-535-6160 (official number) 212-517-3728 April 20, 2006

1. Identification of device

Proprietary Name: Tinnitus Phase-Out Common Name: Tinnitus Masker Classification Status: Class II per Regulation §874.3400 Product Code: KLW - Tinnitus Masker.

2. Equivalent device

Tinnitus Rx - K030791.

3. Description of the Device

The device description of the Tinnitus Phase-Out is as follows:

The Tinnitus Phase-Out consists of a personalized sound recorded onto a patient treatment device. The recorded sound is equivalent to that generated by the Timitus Rx. Performance testing demonstrating this equivalence is presented in the 510(t).

The treatment regimen for the Phase-Out is identical to that of the Rx. The only difference is the use of a patient treatment device instead of a customized CD.

4. Intended Use

The Tinnitus Phase-Out's intended use is to provide temporary relief of tinnitus symptoms. This is the same intended use as previously cleared for themitis
V.020701 K030791.

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5. Discussion of Performance Testing

Bench testing demonstrating audio equivalence has been provided in the 510(k). Additionally, the following have been met:

. UL electrical certification
FDA Guidance describing Special 510(k)s: The New 510(k) Paradigm .
Class II Special Control Guidance, 21 CFR 874.3400(b) .
Conformance to the EU Medical Device Directive.. .

6. Conclusion

In summary, the Tinnitus Phase-Out described in the submission is substantially equivalent to the predicate device, the Tinnitus Rx. The Tinnitus Phase-Out is substantially equivalent to the device already on the market, and presents no new concerns about safety and effectiveness. Additionally, the new device has identical indications to the predicate device, and the labeling is consistent-both with FDA guidance as well as current medical practice.

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Image /page/2/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 an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2005

Tinnitus Control, Inc. c/o Russell P. Pagano, Ph.D. M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002

Re: K061111

Trade/Device Name: Tinnitus Phase-Out Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: April 20, 2006 Received: April 21, 2006

Dear Dr. Pagano:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

M.B. Egelston - M.D.

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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Attachment 2

Indications for Use Statement

510(k) Number (if known)

406111

Device Name

Tinnitus Phase-Out

Indications The Tinnitus Phase-Out is intended to provide the temporary relief of tinnitus symptoms. For Use

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

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

510(k) Number K061111

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.