The ANM T30 CR® Tinnitus Therapy System is intended to provide relief from the disturbance of tinnitus while using the system, and with regular use (over several months) may provide relief to the patient when not using the system.

The ANM T30 CR® Stimulator is a patient device for home use.

The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.

Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age.

Device Description

The ANM T30 CR® is a computer-controlled system for tinnitus therapy is provided to the patient by individualized, ambient acoustic tones. The system consists of four components:

ANM T30 CR® Programmer (computer) including the tinnitus analysis software ANM T30 CR® SW: The ANM T30 CR® Software is used to measure the tinnitus, adjust the individual therapeutic stimulation signals and program the patient device (ANM T30 CR® Stimulator).

ANM T30 CR® Patient Console: The ANM T30 CR® Patient Console is connected to the ANM T30 CR® Programmer and is used by the patient to adjust the parameters specific to his/her tinnitus (frequency and loudness) during tinnitus measurement and stimulation signal adjustment.

ANM T30 CR® Stimulator (patient device): The stimulator is used by the patient for the application of the therapeutic stimulation signal. It has a rechargeable battery for the energy supply and electronic components to generate the stimulation signal.

ANM T30 CR® Earphones: The ANM T30 CR® Earphones are to be connected either to the ANMT30 CR® Patient Console to measure the tinnitus and adjust the stimulation signal or to the ANM T30 CR® Stimulator to apply the stimulation signal.

AI/ML Overview

The provided 510(k) summary for the ANM T30 CR® Tinnitus Therapy System does not contain acceptance criteria or a study that proves the device meets specific performance criteria through clinical data.

Instead, it relies on nonclinical verification and validation testing to establish substantial equivalence to predicate devices. This type of submission generally aims to demonstrate that a new device is "as safe, as effective, and performs as well as or better than" devices already on the market, rather than proving a specific clinical efficacy threshold.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, there are no explicit quantitative acceptance criteria or detailed reported device performance in terms of clinical outcomes. The submission focuses on demonstrating equivalence to predicate devices through technical specifications and intended use.

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
Not explicitly stated in terms of measurable clinical outcomes or performance thresholds.	"The testing shows that the ANM T30 CR® System is as safe, as effective and performs as well as or better than the predicate devices identified in the above Comparison Table."
Compliance with ISO-10993 biocompatibility requirements for patient contact parts	Patient contact parts are manufactured from materials that meet ISO-10993 requirements (tested by suppliers).
Compliance with general electrical safety requirements	Meets applicable general electrical safety requirements of IEC 60601-1 and IEC 60601-1-2.
Maximum output within safety limits (with professional oversight)	Maximum output is 80 dB(A) (software-controlled), can be exceeded to 115 dB(A) with consent of a qualified healthcare professional. Warnings for OSHA 1910.95 given.
Frequency Range	90 Hz - 13 kHz
Audio Signal Technology	Digital
Medium	Flash Memory

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

Sample Size for Test Set: Not applicable / Not provided. The submission focuses on nonclinical testing and comparison to predicate devices, not on a clinical test set with human subjects.
Data Provenance: Not applicable / Not provided. The "testing" mentioned is described as "nonclinical verification and validation testing activities," implying laboratory or engineering tests, not clinical data from patients.

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

Number of Experts: Not applicable / Not provided. Since there's no clinical test set with human subjects requiring ground truth establishment, this information is not relevant to the presented data.
Qualifications of Experts: Not applicable / Not provided.

4. Adjudication method for the test set

Adjudication Method: Not applicable / Not provided. No clinical test set requiring adjudication is described.

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

MRMC Study: No. This device is a tinnitus therapy system that delivers acoustic tones, not an AI-powered diagnostic device requiring human reader interpretation or assistance.
Effect Size: Not applicable.

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

Standalone Performance Study: Not explicitly described in terms of clinical outcomes. The device itself is designed for "standalone" operation by the patient after programming by a healthcare professional, but there's no clinical study described that evaluates the device's performance in isolation without human interaction in a research context. The "Summary of performance data" refers to nonclinical verification and validation testing.

7. The type of ground truth used

Type of Ground Truth: Not applicable / Not provided for clinical performance. For the nonclinical verification, the "ground truth" would likely be engineering specifications, compliance standards (e.g., ISO, IEC), and functional requirements for hardware and software.

8. The sample size for the training set

Sample Size for Training Set: Not applicable / Not provided. This device is not described as involving machine learning or AI that would require a "training set" in the conventional sense.

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

Ground Truth Establishment for Training Set: Not applicable / Not provided. As noted above, the device does not appear to utilize machine learning or AI requiring a training set.

Summary

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

K112752

DEC 1 6 2011

510(k) Summary 5

Company Name:Address:	ANM Adaptive Neuromodulation GmbHIm Mediapark 6d50670 CologneGermany
Telephone:FAX:	+49 (0)221 454-6300 Ext. 6340+49 (0)221 454-6302
Contact person:	Dr. Ingrid RohmQuality & Regulatory Manager
Date summary prepared:	September 9, 2011
Classification Name/Common Name:	Tinnitus Masker
Trade Name:	ANM T30 CR® Tinnitus Therapy System
Product Code:	KLW
Device Classification:	Class II
Predicate Devices:	Neuromonics Tinnitus Treatment System, K043274(Neuromonics PTY Ltd.)TinniTech ANMP System, K030791 (Tinnitech Ltd.)

Device Description:

The ANM T30 CR® is a computer-controlled system for tinnitus therapy is provided to the patient by individualized, ambient acoustic tones. The system consists of four components:

ANM T30 CR® Patient Console:

The ANM T30 CR® Patient Console is connected to the ANM T30 CR® Programmer and is used by the patient to adjust the parameters specific to his/her tinnitus (frequency and loudness) during tinnitus measurement and stimulation signal adjustment.

ANM T30 CR® Stimulator (patient device):

The stimulator is used by the patient for the application of the therapeutic stimulation signal. It has a rechargeable battery for the energy supply and electronic components to generate the stimulation signal.

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

ANM T30 CR® Earphones:

The ANM T30 CR® Earphones are to be connected either to the ANMT30 CR® Patient Console to measure the tinnitus and adjust the stimulation signal or to the ANM T30 CR® Stimulator to apply the stimulation signal.

Patient contact parts are manufactured from materials that meet the ISO-10993 biocompatibility requirement contact with intact skin, as tested by their suppliers. The ANM T30 CR® Tinnitus Therapy System meets the applicable general electrical safety requirements of IEC 60601 1, and the requirements of IEC 60601-1-2.

Intended Use:

The ANM T30 CR® Stimulator is a patient device for home use.

The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.

Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age.

Table 5.1: Comparison to Predicate Device:

	ANM T30 CR® System	Neuromonics Tinnitus Treatment System	TinniTech ANMP System
Intended use	The ANM T30 CR®Tinnitus TherapySystem is intended toprovide relief from thedisturbance of tinnituswhile using the system,and with regular use(over several months)may provide relief tothe patient when notusing the system.The ANM T30 CR®Stimulator is a patientdevice for home use.The ANM T30 CR®Stimulator is fitted andprogrammed by aqualified healthcareprofessional familiarwith tinnitustreatment.Stimulation needs to beapplied for severalhours a day over aperiod of weeks ormonths.The target population isadults over 18 years ofage.	The Neuromonics TinnitusTreatment System isintended to provide relieffrom the disturbance oftinnitus while using thesystem, and with regularuse (over several months)may provide relief to thepatient when not using thesystem.The Neuromonics TinnitusTreatment System isintended to interact andintermittently interact withthe patients tinnitus as partof a tinnitus managementprogram. The addition ofthe music is to aid thepromotion of relaxationduring the tinnitusinteraction process.The initial hearing andtinnitus tests are conductedby a qualified audiologistfamiliar with the treatmentof tinnitus; the subsequentmanagement of thetreatment is carried out byan appropriate healthcare	The ANMP System isintended to completelymask and intermittentlymask tinnitus as part of atinnitus managementprogram. The addition ofthe music is to aid thepromotion of relaxationduring the tinnitus maskingprocess.The initial hearing andtinnitus tests are conductedby a qualified audiologistfamiliar with the treatmentof tinnitus; the subsequentmanagement of thetreatment is carried out byan appropriate healthcareprofessional.The target population forthe device is adults (18years and over) whopresent with tinnitus thatmay or may not beaccompanied with hearingloss at the higherfrequencies and who areparticipating in a tinnitus
	ANM T30 CR® System	Neuromonics Tinnitus Treatment System	TinniTech ANMP System
		professional.	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.
Physical dimensions	ANM T30 CR® Stimulator (1.85" x 1.65" x 0.91") with preprogrammed auditory stimuli delivered through earphones	iPod-like device (4.06" x 2.32" x 0.71") with prerecorded audio stimuli delivered through headphones	The Philips eXanium 401 mini MP3 mini CD player with earphones is supplied by TinniTechSize:3.6" x 4.7" x 1.1" (LxHxD)
Maximum Output Characteristics	Maximum output is 80 dB(A) (software-controlled).This maximum can be exceeded only with the consent of a qualified healthcare professional to 115 dB(A). As this maximum output exceeds the OSHA (Standard 1910.95) 8 hour time weighted average for the occupational workplace, warnings are included in the User Manual	Fixed at 80 dB SPL	The maximum output from the earphones could exceed 85 dBA, the OSHA (Standard 29CFR 1910.95) 8 hour time weighted average for the occupational workplace, and therefore a warning about setting the player volume setting at a comfortable (safe) level is included in the User's Manual and on the player
Frequency Range	90 Hz - 13 kHz	100 Hz - 12.5 kHz	20 Hz - 20 KHz
Audio Signal Technology	Digital	Digital	Digital
Medium	Flash Memory	SD Memory Card	Two mini CDs
Energy used	2.4V, 2 x rechargeable Ni-MH button, 1.2V	Lithium polymer, output 6V	The supplied mini disc player, the Philips eXpanium 401 operates from either one AA cell or a 110 VAC mains adapter provided with the player
Transducer (headphones type)	Use only earphones supplied with the ANM T30 CR® Tinnitus Therapy System. The	Use only earphones supplied with the Neuromonics device. Other earphones may not	Use the earphones provided with the mini disc player
	ANM T30 CR® System	Neuromonics TinnitusTreatment System	TinniTech ANMP System
	stimulation sequenceprogram has beenacoustically alignedspecifically for use withthese earphones	sounds that are essentialfor treatment
Where used	Home use under thesupervision of aqualified healthcareprofessional	Home use under thesupervision of a qualifiedclinician	Home use under themanagement of anappropriate qualifiedhealthcare professional
Safety	Avoid using the ANMT30 CR® TinnitusTherapy System whiledriving or otheractivities that requirethe patient's fullattention	Avoid using theNeuromonics device whiledriving, cycling, or whileperforming any otheractivity that requires thepatient's full attention	The ANMP therapy shouldnever be undertaken whentinnitus masking soundsmight prevent the patientfrom hearing cues orwarnings of likely harm ordanger

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

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

Summary of performance data:

Nonclinical verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the device. Testing involved verification of software requirement specifications from risk analysis. The testing shows that the ANM T30 CR® System is as safe, as effective and performs as well as or better than the predicate devices identified in the above Comparison Table.

Risks to health

With a maximum output of 115 dB(A) the ANM T30 CR® Stimulator could exceed the occupational workplace OSHA standard 29 CFR 1910.95. To avoid possible hearing damage the health care professional only can program the stimulator to allow for acoustic signals above 80 dB(A) for use by tinnitus patients who suffer from impaired hearing.

The User's Manual carries precautions to reduce the acoustic volume or stop the treatment if the auditory stimulation volume is uncomfortable. It also states that stimulation should not been done when undisturbed attention is required.

Hearing Healthcare Professional Diagnosis

The sale and fitting of the ANM T30 CR® system will only be conducted through a Hearing Healthcare Professional.

Benefits

Supported by appropriate counselling and/or tinnitus therapy, relief from tinnitus symptoms may be experienced by using the ANM T30 CR® Stimulator.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ANM Adaptive Neuromodulation GmbH c/o Dr. Ingrid Rohm Quality & Regulatory Manager Im Mediapark 6d 50670 Cologne Germany

DEC 1 6 2011

Re: K112752

Trade/Device Name: ANM T30 CR® Tinnitus Therapy System Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: September 9, 2011 Received: September 21, 2011

Dear Dr. Rohm:

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.

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

Page 2 - Dr. Ingrid Rohm

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Melvina R. Evdelman, M.D.

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

Enclosure

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

K//2+52

Indications for Use 4

510(k) Number (if known):

ANM T30 CR® Tinnitus Therapy System Device Name:

Indications For Use:

The ANM T30 CR® Stimulator is a patient device for home use.

The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.

Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Anne K. Kane Ph.D.

hsion Sign-Off) ision Sign-On)
sion of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number

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.