This software device, Quiescence™, is indicated for use by otolaryngologists, and hearing-aid dispensers (collectively referred to as healthcare professionals) for generating custom masking sounds to mask timitus as part of a tinnitus management program. The target population of the device is adults (18 years and over) who report experiencing timitus, which may or may not be accompanied with hearing loss. Patients should receive a medical evaluation by a licensed physician who specializes in diseases of the ear to rule-out medically or surgically reatable diseases for which tinaitus is a symptom before proceeding with non-medical tinnitus management.

Device Description

Quiescence provides a means for healthcare professionals to custom-make masking sounds for tinnitus patients. This software allows the healthcare professional to try different masking sounds on the patients until one or more suitable ones are found. The masking sounds will be stored to the computer hard disk. This allows the stored masking sound to be written or recorded into other convenient formats such as CD and MP3 player for playback.

AI/ML Overview

The Quiescence Software (K040330) is a tinnitus masker. The information provided in the 510(k) summary focuses on comparing the device to a predicate device (TinniTech ANMP System, K030791) and discussing its technical specifications and intended use. The provided document does not contain explicit acceptance criteria in a quantitative format, nor does it detail a clinical study with a test set, expert ground truth establishment, or sample sizes typically associated with performance evaluations of AI/ML-based medical devices.

Instead, the submission relies on a "brief discussion and conclusion of non-clinical tests and their results" to demonstrate the device's accuracy in producing masking sounds.

Here's an attempt to structure the available information regarding acceptance criteria and the "study":

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly related to the accuracy of the generated masking sounds. The performance is reported as meeting these implicit criteria.

Acceptance Criteria (Implicit)	Reported Device Performance
The masking sound produced by the Quiescence software should match the intended output.	"The results indicated that all the masking sounds generated matched the intended masking sound output."
The algorithms generating the masking sound should be analyzed.	"The algorithms that generate the masking sound were analysed..."
The generated sound should be analyzed before and after passing through the sound output device (headset).	"...and the generated sound was also analysed before and after it passed through the sound output device (headset)."
Spectrum analysis should be used to ensure the proper frequency content in the masking sound.	"When analyzing the masking sound, spectrum analysis was used to ensure the proper frequency content in the masking sound."
The generated masking sound should be as effective as what other masking devices would generate (implied by substantial equivalence claim).	"This clearly indicates the masking sound generated by the Quiescence software will be as effective as what other masking devices would generate." (This is a conclusion drawn from the technical accuracy, not a direct clinical effectiveness study against other devices in this document).
The device must include warnings/alerts for output levels exceeding user-defined limits (default 85 dBA, alert at 80 dB SPL) to prevent hearing damage.	"The software will also display a warning message to alert healthcare professional when the output is going to exceed a user-defined limit. The default limit of the software ensures that the output is below 85 dBA."
User's guide must include permissible noise exposure duration and corresponding noise level.	"The user's guide of Quiescence includes the list of permissible noise exposure duration and the corresponding noise level."
Final recording of masking sounds must include specific warning labels as proposed.	"The following warning label is proposed to be included with the recording of the masking sounds generated by Quiescence:" [Warning text provided]
Healthcare professionals should provide adequate instruction to the patient. Appendix A of the User's Guide should contain cautionary and usage information for patients.	"Furthermore, the healthcare professional should provide the patient with adequate instruction to use the masking sound(s) at home. Appendix A of the Quiescence User's Guide contains cautionary and usage information for tinnitus patients that healthcare professionals should distribute..."

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

The provided document describes non-clinical engineering tests, not a clinical study involving patients or a test set of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this device's submission as described. The testing focused on the device's technical output accuracy.

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

Not applicable. This was a non-clinical engineering test of sound output accuracy, not a clinical evaluation requiring expert-established ground truth on patient data. The "ground truth" was the intended sound output specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or human adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study was not performed or referenced in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device based on intended use, technology, and non-clinical performance (accuracy of sound generation).

6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, in a way. The "brief discussion and conclusion of non-clinical tests" can be considered a standalone performance evaluation of the algorithm's output, without direct human-in-the-loop performance influencing the sound generation itself. The software's ability to produce the correct sounds according to its design specifications was tested.

7. The Type of Ground Truth Used

The ground truth used was technical specifications/intended output parameters for the generated masking sounds. The tests aimed to verify that the software's output (frequency content, etc.) matched these predefined engineering targets.

8. The Sample Size for the Training Set

Not applicable. This device is described as software that "creates custom masking sounds" using "algorithms." There is no indication that it is an Machine Learning (ML) algorithm that requires a "training set" of data in the conventional sense. It appears to be a deterministic sound generation software.

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

Not applicable, as there is no apparent training set for an ML algorithm. The "ground truth" for the software's functionality resides in its design specifications for generating various types of sounds (pure tone, FM tone, etc.) with specific parameters.

Summary

{0}------------------------------------------------

K040330

APR 1 2 2004

510(k) Summary for Quiescence Software

Date summary was prepared	November 13, 2003
Applicant's Name & Address	Spectral Visualization and Development (SVD) Inc921 College Hill Road,Fredericton, NB E3B 6Z9Canada
Establishment Number:	3004176728
Contact Person, Telephone andemail address:	Dennis Woo506-460-1625dwoo@svdinc.com
Device Trade or Proprietaryname:	Quiescence
Classification name:	Tinnitus masker
Classification of Device	Class II
Product Code:	KLW
Marketed device to which theclaim of substantial equivalence ismade:	K030791TinniTech ANMP System

{1}------------------------------------------------

Comparison to equivalent device Quicscence vs. TinniTech ANMP System (K030791):

	Quiescence SoftwareK040330	TinniTech ANMP SystemK030791
Intended Use	Creating masking sound to masktinnitus as part of tinnitusmanagement program.	Continuously and intermittentlymask tinnitus as part of a tinnitusmanagement program with maskingnoise.
Target Population	The software is targeted forhealthcare professionals to createcustom masking sounds for tinnituspatients.The masking sound created by thehealthcare professional may be usedby adult (age 18 years and over) thatare participating in a tinnitusmanagement program.	Adults (18 years and over) with andwithout high frequency loss, withtinnitus who are participating in atinnitus management program.
	Quiescence SoftwareK040330	TinniTech ANMP SystemK030791
Operation
Audio Signal Technology	Digital	Digital
Available noises/sounds	Pure tone, FM tone, pulse pure tone,narrowband noise, speech noise andwhite noise. Except for speechnoise, and white noise, the centerfrequency of other sounds isadjustable from 100 Hz to 20000 Hz.	Pre-adapted to the patient's hearingcharacteristics, a wide selection ofmusical sounds incorporatingTinnitus Masking noise (20Hz - 20kHz) digitally recorded on minicompact disc in MP3 format.
Medium	Healthcare professional will use thesoftware to generate the desiremasking sound(s). The resultingsound(s) can be saved in anymedium that is convenient to thepatient. A common medium wouldbe an audio digital compact disc(CD).	Two mini CDs and can be expandedby providing a variety of music onadditional discs.
Volume Control	Volume is controlled by the patient.Healthcare professionals areprovided with warning messages tobe included with the maskingsounds.	User controlled with warning in theUser Instruction Manual.
Distribution	The Quiescence software is onlyavailable to otolaryngologists,audiologists and hearing-aiddispensers. The masking sound(s)created by the healthcareprofessional is directed to thetinnitus patient under the directsupervision of the healthcareprofessional.	To be sold via direct and indirectchannels involving an appropriatelyqualified healthcare professional.
	Quiescence SoftwareK040330	TinniTech ANMP SystemK030791
Energy delivered	The output of most computer soundcard can provide an outputexceeding 85 dBA which requiresthe proper observation of the OSHApermissible noise exposure standard.The user's guide of Quiescenceincludes the list of permissible noiseexposure duration and thecorresponding noise level. Thesoftware will also display a warningmessage to alert healthcareprofessional when the output isgoing to exceed a user-defined limit.The default limit of the softwareensures that the output is below 85dBA.	Max. output could exceed 85 dBA
Characteristic	New device	Predicate device
Where used	The healthcare professional will useQuiescence to generate suitablemasking sound(s) for the tinnituspatient to use at home underdirection supervision of thehealthcare professional.	Home used under the management ofan appropriately qualified healthcareprofessional.
Instructions	The Quiescence device comes with aUser's Manual.	The TinniTech ANMP Systemcomes with a User's Guide.
Risk	There is no risk associated to the masking sounds\ that Quiescence createdif they are used as directed by the healthcare professional.
Hearing HealthcareProfessional diagnosis	The masking sound is only available though qualified healthcareprofessionals such as audiologist or otolaryngologist.
Benefits	Like other tinnitus maskers, the masking sound generated by the Quiescencesoftware may provide relief to tinnitus symptoms when utilized properlyunder the directions of the healthcare professional.
Warnings	The Quiescence software is capable of delivering sound output level of over85 dBA which exceed the OSHA standard. To avoid hearing damage,Quiescence will alert the healthcare professional when the output level is setbeyond 80 dBSPI. This output level is chosen to ensure that the

{2}------------------------------------------------

{3}------------------------------------------------

Description of Device

{4}------------------------------------------------

more suitable ones are found. The masking sounds will be stored to the computer hard disk. This allows the stored masking sound to be written or recorded into other convenient formats such as CD and MP3 player for playback.

Intended Use of Device Creating masking sounds to mask tinnitus as part of a tinnitus management program.

Brief discussion and conclusion of non-clinical tests and their results.

The key to a tinnitus masker is the accuracy of the masking sound. There is no better way to qualify the accuracy of the masking sound using engineering tests. The masking sound produced by the Quiescence software was tested repeatedly to ensure that the sound matched the intended output. The algorithms that generate the masking sound were analysed and the generated sound was also analysed before and after it passed through the sound output device (headset). When analyzing the masking sound, spectrum analysis was used to ensure the proper frequency content in the masking sound.

The results indicated that all the masking sounds generated matched the intended masking sound output. This clearly indicates the masking sound generated by the Quiescence software will be as effective as what other masking devices would generate.

Information required under Title 21, Section 874.3400 and not already provided above

{5}------------------------------------------------

corresponding dBA-weight output level will not be exceeded throughout the frequency range of Quiescence. The following warning label is proposed to be included with the recording of the masking sounds generated by Quiescence:

CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF AN OTOLARYNGOLOGIST, AUDIOLOGIST OR HEARING-AID DISPENSER. FURTHEREMORE, THIS DEVICE MAY HARM YOUR HEARING IF IT IS NOT USED AS DIRECTED BY YOUR OTOLARYNGOLOGIST, AUDIOLOGIST OR HEARING-AID DISPENSER.

Furthermore, the healthcare professional should provide the patient with adequate instruction to use the masking sound(s) at home. Appendix A of the Quiescence User's Guide contains cautionary and usage information for tinnitus patients that healthcare professionals should distribute before handing out the hard copy of the masking sounds to patients.

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the bird symbol placed inside the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2004

Spectral Visualization Ndd Development (SVD) Inc. c/o Dennis Woo, Ph.D., P.Eng. 921 College Hill Road Fredericton, NB E3B 6Z9 Canada

Re: K040330

Trade/Device Name: Quiescence™ Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: February 9, 2004 Received: February 25, 2004

Dear Dr. Woo:

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 cither 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{7}------------------------------------------------

Page 2 - Dennis Woo, Ph.D., P.Eng.

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) 594-594-4613. 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/cdrh/dsma/dsmamain.html

Sincerely yours,

David Th. Whizzle

A. Ralph Rosenthal, M.D.

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

Enclosure

{8}------------------------------------------------

040330

Indications for Use

510(k) Number (if known): K040330

Device Name: Quiescence

Prescription Use: (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use:

(21 CFR 807 Subpart C)

starite below this line - continue on another page if needed) (Division Sign-Off) Division of Ophthalmic Er Concurrence of CDRH, Office of Device Evaluation ODE Nose and Throat-Devises 510(k) Numbe TOTAL P.03

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.