The CST system is a CD with software that enables a qualified healthcare professional to identify, with the patient's verbal input, the sounds that most closely match the patient's tinnitus. The device is indicated to mask and intermittently mask tinnitus as part of a tinnitus management program. The target population for the device is adults (18 years and over) who present with timitus, that may or may not be accompanied with hearing loss at the higher frequencies, and who are participating in a tinnitus management program.

Device Description

The Tinnitus Otosound Products LLC (TOP-LLC), Customized Sound Therapy (CST), falls under devices described in 21 CFR 874.3400 Class II, product code KLW. The device is a CD comprised of software with two components: a graphic user interface and cmusic program. The software can be used on a notebook or desktop computer with at least Windows XP (SP2) having at least a 1.2 GHz Pentium III CPU (or equivalent), 256 MB of RAM, 1 GB of free disk space, a CD drive, and an available USB port.

The Customized Sound Therapy software produces, and transfers sounds to a sound wave file. This sound file can be stored on any commercially available computer hard drive or portable audio device (PAD) like an iPod.

AI/ML Overview

The provided text is a 510(k) summary for the "Customized Sound Therapy (CST)" device, a Tinnitus Masker Device. It aims to establish substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving those criteria are not explicitly present in the document in the format usually associated with performance studies against pre-defined metrics.

However, I can extract information related to the device's characteristics and the basis for its approval.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not present specific quantitative acceptance criteria or a performance table in the way a clinical study typically would. The basis for approval is Substantial Equivalence to legally marketed predicate devices. This means the FDA determined that the CST device is as safe and effective as the predicate devices. The "performance" in this context is implicitly considered equivalent to the predicates.

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness (Implicit through Substantial Equivalence)	The CST device is believed to be as safe and effective as the predicate devices: 1. Petroff Audio Technologies Inc. Dynamic Tinnitus Mitigation System, DTM-6 (K974501) 2. Neuromonics (formerly TiniTech) TinniTech ANMP System (K030791) The device's intended use is to "mask or intermittently mask the patient's tinnitus as part of a tinnitus management program." Warnings regarding playing sounds at uncomfortable levels and not using if it prevents hearing warning sounds of danger are explicitly stated as safety measures.
Functional Equivalence	The CST software produces and transfers sounds to a sound wave file, which can be stored on a computer or portable audio device. This function is analogous to the sound-producing and delivery mechanisms of existing tinnitus maskers.
Intended Use Equivalence	The intended use of CST is consistent with that of existing tinnitus maskers: to provide temporary relief from the disturbance of tinnitus by masking or intermittently masking it.
Technological Characteristics Equivalence	The device is a CD with software that uses a "cmusic acoustic compiler and a proprietary graphic user interface" to create individualized sounds. This technological approach is deemed comparable to the sound generation methods employed by predicate devices. Standard commercially available computer and audio equipment is used.

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

The 510(k) summary does not mention a specific test set, sample size, or data provenance (country of origin, retrospective/prospective) for a performance study. 510(k) submissions focusing on substantial equivalence often rely on comparative analysis to predicates rather than new clinical data, especially for Class II devices like this one.

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

This information is not provided in the document. As there's no mention of a dedicated test set or ground truth establishment for a performance study, the number and qualifications of experts for this purpose are not applicable in this context.

4. Adjudication Method for the Test Set

This information is not provided in the document, as no specific test set requiring adjudication is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not described in the provided 510(k) summary. The document does not discuss human reader performance, AI assistance, or an effect size.

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

No, a standalone performance study of the algorithm is not explicitly described in the document. The device description emphasizes the role of a "qualified audiologist or other qualified professional" in controlling the software and sound matching with the patient's verbal input. This implies a human-in-the-loop system for creating the personalized sound files, rather than a fully standalone algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in performance studies (e.g., pathology, outcomes data) is not applicable here in the context of proving specific device performance metrics against a gold standard. The "ground truth" for the device's function is the patient's subjective perception of their tinnitus and the effectiveness of the generated sound in masking it, as determined through the interaction with a qualified professional. The professional, with patient input, identifies sounds that "most closely match the patient's tinnitus."

8. The Sample Size for the Training Set

There is no mention of a training set sample size. The software is described as based on the cmusic acoustic compiler and a proprietary graphic user interface, implying it's a tool for sound generation rather than a machine learning model trained on a dataset to make predictions.

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

Not applicable, as there is no mention of a training set or ground truth establishment for a machine learning model. The software's functionality seems to be based on acoustical principles for sound generation and a user interface for customization, rather than being "trained" on a dataset with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K070599" in a handwritten style. Below this, the text "JUL 13 2007" is printed in a simple, sans-serif font. The text appears to be part of a document or label, possibly indicating a date or identification number.

510K Summary

APPLICANT: ADDRESS:

CONTACTS:

Geraldine Crean, Ph.D. Regulatory Liaison, Tinnitus Otosound Products, LLC gerldinecrean@yahoo.com 310-927-6151

Anthony Materna, Ph.D. CEO, Tinnitus Otosound Products, LLC tmaterna@top llc.net

Tinnitus Otosound Products, LLC

880 First Street, Suite 403

Los Angeles, CA 90012

DATE OF SUBMISSION:

February 28, 2007

310-273-8217

213-626-0927

TRADE OR PROPRIETARY NAME: Customized Sound Therapy

COMMON OR UNUSUAL NAME(S): CST

CLASSIFICATION NAME:

Tinnitus Masker Device (TMD) Described in 21 CFR 874.3400 Class II, product code KLW

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PREDICATE DEVICE(S)

Petroff Audio Technologies, Inc. Manufacturer: Tradename: Dynamic Tinnitus Mitigation System, DTM-6 510K Number: K974501

Manufacturer: Neuromonics (formerly TiniTech) Tradename: TinniTech ANMP System 510K Number: K030791

SUBSTANTIAL EQUIVALENCE

Customized Sound Therapy is claiming substantial equivalence to two devices.

Equivalence to the Dynamic Timitus Mitigation System, DTM-6, manufactured by Petroff Audio Technologies Inc. 510K number K974501.
Equivalence is also claimed to the TinniTech ANMP System, manufactured by Neuromonics (formerly TiniTech). 510K number K030791

DEVICE DESCRIPTION

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DESCRIPTION OF DEVICE DESIGN

The CST software consists of specialized programs for creating the CST sounds, which are matched as closely as possible to the tinnitus sensation experienced by the patient. The CST software is based on the cmusic acoustic compiler and a proprietary graphic user interface developed specifically for use during sound matching with CST [1; Chapter 3, pp. 150-214; Appendix D, pp. 490-546]. - Under control of a qualified audiologist or other qualified professional, the CST software writes the matching sound on the hard drive of the computer. A copy of this sound is transferred to a commercially available portable audio device for use by the patient during therapy. The volume control on the PAD is used to match that apparent level of the CST sound to the patient's tinnitus sensation as subjectively judged by the patient.

The system is intended to provide relief from the disturbance of tinnitus in an attempt to provide temporary relief of the effect of tinnitus

INTENDED USE

The TOP-LLC CST is intended for use by a qualified healthcare professional such as an otolaryngologist, an audiologist, or other qualified professional. It is intended to mask or intermittently mask the patient's tinnitus as part of a tinnitus management program.

Patients receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with CST. Initial hearing and tinnitus tests are conducted by a qualified audiologist familiar with the treatment of timitus; subsequent management of the treatment is carried out by an audiologist or other qualified professional.

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INDICATIONS FOR USE

The CST system is a CD with software that enables qualified professional to identify, with the patient's verbal input, the sounds that most closely match the patient's tinnitus. The device is indicated to mask and intermittently mask tinnitus as part of a tinnitus management program. The target population for the device is adults (18 years and over) who present with tinnitus, that may or may not be accompanied with hearing loss at the higher frequencies, and who are participating in a tinnitus management program.

RISKS AND WARNINGS FOR SAFE USE

The software packaging and the CD are clearly marked with two warnings: 1) the sounds on the discs should not be played at uncomfortable levels, and 2) the CST system should not be used if such use prevents the user from hearing sounds warning of danger (like the beeping of oncoming vehicles).

The following caution statement is also on the software packaging and the CD:

Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of this device.

DEVICE CHARACTERISTICS

The CST device consists of computer software, which identifies, produces and transfers custom sounds, CST, from a desktop or laptop to a PAD. The CST software is based on the cmusic acoustic compiler (standard in generating computer music) that includes a proprietary graphic user interface developed specifically for use during sound matching with CST [1]. CST software will be use with standard computer and audio equipment that is commercially available. The standard commercially available components are intended for use as designated by the manufacturer.

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CONCLUSIONS

CST is equivalent to tinnitus masking devices already approved for marketing.

REFERENCES

[1] Moore, F. R. Elements of Computer Music (Prentice-Hall, 1990)

[2} Folmer, R.L. Long-term reductions in tinnitus severity. BMC Ear, Nose, and Throat Disorders, 2002, 2(3): 1-9.

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Image /page/5/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 a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2007

Tinnitus Otosound Products, LLC c/o Geraldine Crean, Ph.D. 880 First Street, Suite 403 Los Angeles, CA 90012

Re: K070599

Trade/Device Name: Customized Sound Therapy (CST) Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: May 22, 2007 Received: May 24, 2007

Dear Dr. Crean:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egleston, MD

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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Indications for Use

KOZOS 510(k) Number: "

Device Name: Customized Sound Therapy (CST)

Indicaitons For Use:

Perscription Use: X (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use

(Part 21 CFR 801 Subpart D)

(12 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Drug Evaluation (ODE)

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Prescription rescription of CFR 801.109) Page 1 of

Elm Chen Peng
(Division Sign-Off)
Division of Ophthalmic Ear,

Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K01054

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.