The UltraQuiet™ device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuiet™ device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuiet™ is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.

Device Description

The UltraQuiet™ consists of (1) a compact disc (CD) with recorded sound or an MP3 player, (2) an audio amplifier with AC adapter power supply, and (3) a headband/bone-conduction transducer assembly.

AI/ML Overview

The UltraQuiet™ device, a tinnitus masker, did not undergo a study with specific acceptance criteria and reported device performance in the provided document. The submission is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices rather than proving performance against specific quantitative criteria.

The document highlights the intended use and technological characteristics of the UltraQuiet™ device and how they are substantially equivalent to existing predicate devices. The equivalence is based on similar principles of operation, general intended use, and technological features, rather than a clinical study demonstrating a specific level of performance or efficacy.

Here's a breakdown of the requested information based on the provided text, indicating where information is present and where it is not applicable for a 510(k) submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Applicable (No specific quantitative acceptance criteria or performance metrics were defined or reported in the document for FDA clearance for this 510(k) submission. The clearance is based on substantial equivalence to predicate devices.)	Not Applicable (The document asserts functional equivalence to predicate devices based on shared features, such as providing broadband masking sound, delivering sound via bone conduction, tunability of sound, and using recorded noise. It does not provide quantitative performance data against acceptance criteria.)

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. No test set or clinical study was conducted or reported in this 510(k) submission to demonstrate performance against specific criteria.
Data Provenance: Not applicable. As no test set was used, there is no corresponding data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment by experts was reported for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No adjudication method was reported as no test set was used.

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 interpretative tool. Therefore, an MRMC study and effects on human reader performance are not relevant.

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

Not applicable. This is a medical device (tinnitus masker), not an AI algorithm. Its function is to produce masking noise, not to interpret data or make a diagnosis independently.

7. The type of ground truth used

Not applicable. No ground truth was established as part of this 510(k) submission’s review process. The submission focuses on substantial equivalence to predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the 510(k) Approach:

The K021202 submission for the UltraQuiet™ device sought clearance by demonstrating substantial equivalence to several predicate tinnitus maskers (Siemens TCI, ADM Tronics Aurex-3, Starkey TM-3/TM-5, and TTC's GHI-T & TN3-T-T). This approach, common for Class II medical devices, does not typically involve extensive clinical trials with pre-defined acceptance criteria and performance metrics for the new device. Instead, the focus is on showing that the new device has:

The same intended use.
Similar technological characteristics.
Similar principles of operation.
Does not raise different questions of safety and effectiveness compared to the legally marketed predicate devices.

The document states that UltraQuiet™ is "functionally equivalent" to its predicates in terms of providing broadband masking sound, bone conduction delivery, tunability, and use of recorded noise. This "functional equivalence" is the basis for its clearance, not a study demonstrating new performance metrics.

Summary

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K021202

'JUL 1 3 2002

Attachment 7

510(k) SUMMARY

Sound Technique Systems, LLC: UltraQuiet™

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

Sound Technique Systems, LLC 710 Denbigh Boulevard, Suite 2C Newport News, VA 23608

Phone: (757) 833-6794 Facsimile: (757) 833-7406

Contact Person: Martin Lenhardt

Date Prepared: March 27, 2002

Name of Device and Name/Address of Sponsor

UltraQuiet™

Sound Technique Systems, LLC 710 Denbigh Boulevard, Suite 2C Newport News, VA 23608

Common or Usual Name

Tinnitus Masker

Classification Name

Tinnitus Masker Product Code: KLW

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Predicate Devices

K003559	Siemens TCI Tinnitus Control Instrument
K981704	ADM Tronics Aurex-3 tinnitus masker
K964216	Starkey TM-3, TM-5 High Frequency Tinnitus Masker
K982451	TTC's GHI-T & TN3-T-T tinnitus masker

Intended Use

Technological Characteristics and Substantial Equivalence

The Company's UltraQuiet™ device covered by this submission is substantially equivalent to other legally marketed tinnitus maskers. Specifically, the UltraQuiet™ device is substantially equivalent to Siemens' Tinnitus Control Instrument (TCI) (K003559), ADM Tronics' Aurex-3 Tinnitus Masker (K9817040), Starkey Laboratories' Starkey TM-3, TM-5 High Frequency Tinnitus Masker (K964216), and the Tinnitus Treatment Centers' TTCGHI- and TTCTN3-T-T devices (K982452).

UltraQuiet™ has the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices (K003559, K981704, K964216 and K982452). The UltraQuiet™ device and its predicate devices are all tinnitus maskers. The UltraQuiet™ is functionally equivalent to the Siemens' TCI (K003559) in that it provides broadband masking sound at a similar level of intensity (<76 dB SPL equivalent). It is functionally equivalent to the Aurex-3 (K9817040) in that it delivers the masking sound through bone conduction via the mastoid. It is functionally equivalent to Starkey's TM-5 (K964216) because the masking sound included

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is tunable (1 kHz - 15 kHz) and provides high frequencies in the audible range (≤15 kHz). Finally, UltraQuiet™ is functionally equivalent to the Tinnitus Treatment Centers' tinnitus masker (K982452) because both devices use recorded noise (the former on a CD and the latter on an audio cassette).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2002

Hogan & Hartson L.L.P. c/o Howard M. Holstein Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Re: K021202

Trade/Device Name: UltraQuiet™ Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: April 15, 2002 Received: April 16, 2002

Dear Mr. Holstein:

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.

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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Page 2 -- Howard M. Holstein

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Attachment 8

Indications for Use Statement

Applicant: Sound Technique Systems, LLC

510(k) Number (if known): not yet assigned

Device Name: UltraQuiet™

510(k) Number K021202

Prescription Use (Per 21 CFR 801.109)

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.