The TinniTech ANMP System comprises two (2) mini compact disks and a portable, stereo, MP3 mini compact disc player with earphones. The discs have been prerecorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient's spectral hearing thresholds as shown by their audiogram. The sounds on the discs are reproduced by the mini compact disc player and delivered to the ears by the earphones supplied with the player. The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program.

The TinniTech ANMP System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist, an audiologist, or a licensed hearing aid dealer.

Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surqically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.

The Tinnitech ANMP System may be used to completely mask and intermittently mask tinnitus.

Device Description

The TinniTech ANMP system consists of:

One CD pre-recorded in the MP3 format with selected relaxation music and superimposed low amplitude, wide spectrum noise that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss. This CD is intended for the complete masking of tinnitus.

One CD pre-recorded in the MP3 format with selected relaxation music that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss however this CD has been recorded such that the dynamic characteristics of the sound allow the tinnitus to intermittently break through during the quieter passages of the recorded music.

A commercially available, battery powered, stereo, MP3 mini compact disc player with earphones with a performance specification that TinniTech has tested and shown to be suitable for the delivery of the ANMP treatment sounds or waveforms. At this time Tinnitech will supply the Phillips eXpanium 401™ MP3 mini compact disc player. Other suitable players will be offered as TinniTech tests and approves them for the ANMP System.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the TinniTech ANMP System, based on the provided 510(k) summary:

Important Note: The provided 510(k) summary is for a tinnitus masker, which is a device designed to provide temporary relief by masking the sound of tinnitus. It is not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device testing (like sample sizes for test and training sets, expert consensus for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of traditional medical device. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving performance against specific quantitative acceptance criteria through clinical studies in the way an AI/ML device would.

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission for a traditional tinnitus masker, the "acceptance criteria" are primarily met through demonstrating similarity in intended use, technological characteristics, and safety/performance to legally marketed predicate devices. The "reported device performance" is descriptive and qualitative rather than quantitative metrics from a clinical trial.

Characteristic/Acceptance Criteria (as implied by substantial equivalence)	Reported TinniTech ANMP System Performance
Intended Use Equivalence: Continuously and intermittently mask tinnitus as part of a tinnitus management program with masking noise and selected relaxation music.	Met: Indicated to completely mask and intermittently mask tinnitus as part of a tinnitus management program. Music added to promote relaxation. (Matches predicate K974501 for relaxation, and K011364 for continuous/intermittent masking).
Target Population Equivalence: Adults (18 years and over) with tinnitus, with or without high frequency loss, participating in a tinnitus management program.	Met: Adults (18 years of age 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. (Broader than K974501, similar to K011364 for adults).
Audio Signal Technology: Digital audio.	Met: Digital (MP3 format on mini CDs). (Matches both predicates).
Available Noises/Sounds: Custom-tailored (spectrally adapted) and includes relaxation music.	Met: Pre-adapted to the patient's hearing characteristics, a wide selection of musical sounds incorporating Tinnitus Masking noise (20Hz - 20KHz) digitally recorded on mini compact discs in MP3 format. Custom-tailors sounds based on audiogram. (Matches K011364 for custom-tailoring; K974501 for masking noise + relaxation).
Medium: Portable digital storage medium (CDs).	Met: Two mini CDs (MP3 format). (Similar to K974501's four CDs/audio tapes; different from K011364's solid state memory but functionally equivalent for portability and delivery).
Volume Control: User-controlled with warnings.	Met: Yes, user controlled with warning in the User Instruction Manual stating "To prevent the possible damage to your hearing the volume setting of the disc player should not be set at levels where you are uncomfortable with the sound". (Similar to both predicates).
Distribution: Through qualified healthcare professionals.	Met: To be sold via direct and indirect channels involving an appropriately qualified healthcare professional. (Similar to K011364, more controlled than K974501).
Components: Sound files on storage, player, earphones, user manual.	Met: Sound files on digital mini CDs, high quality digital MP3 mini CD player, earphones, User's Manual. (Similar to K974501 components; K011364 is an in-the-ear device).
Energy Delivered/Safety (Acoustic Output): Maximum output considered, warnings provided if exceeding OSHA limits.	Met: Philips eXpanium 401 has a maximum power output per channel of 5mW. Maximum output from earphones could exceed 85 dBA (OSHA standard). Warnings included in User's Manual and on player. (Similar to K011364's warning; K974501 has no stipulated max).
Energy Used: Battery or mains powered.	Met: Operates from either one AA cell or 110 VAC mains adapter. (Similar to both predicates).
Transducer Type: Headphones/earphones.	Met: Use the earphones provided with the mini disc player. (Similar to K974501's headphones; K011364 is an in-the-ear device).
Where Used: Home use under professional management.	Met: Home use under the management of an appropriately qualified healthcare professional. (Similar to K011364; K974501 is home use only).
Safety: Warnings about preventing hearing damage and inability to hear external cues.	Met: ANMP therapy should never be undertaken when sounds might prevent hearing warnings of danger. Warnings about uncomfortable volume levels. (Similar safety considerations as K974501).
Materials: Typical audio product materials.	Met: Typical audio product materials such as plastic and diecast metals. (Similar to K974501).
Performance (User Determination): Enables user to determine if therapy assists in tinnitus management.	Met: The TinniTech ANMP system enables the user to determine whether the delivered therapy assists in the management of their tinnitus. (Similar to both predicates).
Instructions: User's Guide provided.	Met: The TinniTech ANMP System comes with a User's Guide. (Similar to K974501's Workbook).

Study Information (Not applicable for this type of device seeking substantial equivalence via comparison to predicates for performance validation)

As this is a substantial equivalence submission for a non-AI/ML medical device, the typical "study" to prove performance is a comparison to legally marketed predicate devices, not a clinical trial with acceptance criteria for quantitative metrics. The document explicitly states it is claiming substantial equivalence to two predicate devices, leveraging their established safety and effectiveness.

Sample size used for the test set and the data provenance: Not applicable. Performance is established through comparison of technological characteristics and intended use to predicate devices, not a separate test set. The submission does not describe a new clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance in this context is established by the existing regulatory approval and market history of the predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices through their own regulatory clearance and market experience. The demonstration of equivalent intended use and technological characteristics to these predicates serves as the basis for substantial equivalence.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary of Approach:

The TinniTech ANMP System did not undergo a formal clinical study with quantifiable performance metrics and acceptance criteria in the way a novel diagnostic or therapeutic device would. Instead, its acceptance was based on demonstrating substantial equivalence to two previously cleared predicate devices:

K974501 (Dynamic Tinnitus Mitigation System, DTM-6): Used to establish equivalence for the masking function, inclusion of relaxation sounds, and overall concept of CD-based delivery.
K011364 (Custom TCI Instrument): Used to establish equivalence for the custom-tailoring of sounds (spectral adaptation based on audiogram) and the concept of intermittent masking for habituation.

The 510(k) summary provides a detailed comparison table showing the technological characteristics, intended use, target population, and safety considerations of the TinniTech ANMP System against these two predicate devices. The successful clearance (K030791) by the FDA indicates that the agency found these comparisons sufficient to demonstrate substantial equivalence, meaning the new device is as safe and effective as the legally marketed predicates.

Summary

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KO30791

APR 1 7 2003

510(k) SUMMARY

TinniTech ANMP System

Applicant:	TinniTech LtdLevel 2, 55 Market StreetSydney NSW 2000AustraliaPhone: +61 2 9283 0601Fax: +61 2 9283 0602
Date ofSubmission:	28 February 2003
Manufacturing Site:	ResMed Ltd.97 Waterloo RoadNorth Ryde NSW 2113Australia
EstablishmentRegistrationNumber:	8020057
Distributor:	Mr R West, Go West, Inc.2502 Tournament CourtCastle Rock, CO 80104Phone/Fax: (303) 663-8089
Contact Name forSubmission:	Lachlan James(contact address as per Applicant)
Trade orProprietary Name	ANMP (Acoustic Neuro Modulation Protocol)
Common or UsualNames	Tinnitus Masker
Classification Name(FDA)	KLW : Masker Tinnitus
Classification	Class II device

Comments of the comments of

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Indications for Use:

The TinniTech ANMP System comprises two (2) mini compact disks that have been prerecorded with selected relaxation music and other sounds spectrally adapted to suit the particular patient's hearing thresholds. The device is indicated to mask and intermittently mask tinnitus as part of a tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus masking process.

The spectral adaptation of the sound is determined by the patient's audiogram measured by a qualified audiologist; the patient's tinnitus therapy is managed by an appropriate healthcare professional. The target population for the device is adults (18 years of age and over) who present with tinnitus that may or may not be accompanied with hearing loss at the higher frequencies.

Intended use

The ANMP System is intended to completely mask and intermittently mask tinnitus as part of a tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus masking process. The initial hearing and tinnitus tests are conducted by a qualified audiologist familiar with the treatment of tinnitus: the subsequent management of the treatment is carried out by an appropriate healthcare professional.

Target population

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.

Device description

The TinniTech ANMP system consists of:

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Substantial equivalence

TenniTech is claiming substantial equivalence to two devices:

Equivalence is claimed to the Dynamic Tinnitus Mitigation System, DTM-6 manufactured by Petroff Audio Technologies Inc. 510k number; K974501

Equivalence is also claimed to the Custom TCI Instrument manufactured by Siemens Hearing Instruments, 510k number; K011364.

K974501

The Dynamic Tinnitus Mitigation System, DTM-6 manufactured by Petroff Audio Technologies Inc. 510k number; K974501 is a four (4) CD set system capable of being played on any commercial CD player with headphones or speakers. CD#1 provides digital tinnitus masking sounds only, CDs #2, #3 and #4 provide digital tinnitus masking sounds plus relaxation messages, alpha rhythms (a gentle musical sound generated on electronic musical instruments), music and/or nature sounds. CDs #2. #3 and #4 add the indication of promoting relaxation during the tinnitus masking process to the indication of providing 'temporary relief of tinnitus symptoms'.

Like the predicate device K974501 the TinniTech ANMP sounds are recorded on mini CDs (in the MP3 format) capable of being played on any one of a number of good quality, portable MP3 mini disc players, the patient using appropriate earphones to listen to the sound recorded on the discs.

The TinniTech ANMP, like CDs #2. #3 and #4 of the predicate device includes on CD1 digital tinnitus masking sounds together with selected musical sounds to promote relaxation during the tinnitus continuous masking process.

K011364

The Custom TCI Instrument manufactured by Siemens Hearing Instruments, 510k number: K011364. is a fully digital. low level noise generator. The device is programmable, with selected noise and output levels and is indicated for use in the delivery of tinnitus habituation and tinnitus masking therapies.

The output noise in the Custom TCI Instrument can be custom-tailored to the user's individual requirements.

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Like the predicate device, K011364, the TinniTech ANMP custom-tailors the sounds on both CD 1 and CD 2 to suit the individual patients' hearing requirements. This is achieved analysing the patient's audiogram and boosting the amplitude of those sounds or tones where the patient has been shown to have a reduced hearing threshold.

The TinniTech ANMP also includes on CD 2 specially selected music with a dynamic characteristic that allows the patient's tinnitus sound to intermittently break through the masking effect of the music. This function, like the predicate device K011364, assists in enhancing the patient's habituation to the tinnitus sound.

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Characteristic	New Device	Predicate DeviceK974501	Predicate DeviceK011364
Intended Use	Continuously andintermittently masktinnitus as part of atinnitus managementprogram with maskingnoise and selectedmusic to promote therelaxation of thepatient during thedelivery of theTinnitech ANMPtherapy.	Temporary relief oftinnitus symptoms andthe promotion ofrelaxation during thetinnitus maskingprocess.	Continuously maskand partially masktinnitus as part of atinnitus managementprogram.
Target Population	Adults (18 years andover), both with andwithout highfrequency loss, withtinnitus who areparticipating in atinnitus managementprogram.	All tinnitus sufferers,including thatpercentage of severesufferers who are "un-maskable" through theapplication of amasking sound.	Adults and children(over 5 years of age)with tinnitus who areparticipating in atinnitus
Audio signaltechnology	Digital	Digital	Digital
Availablenoises/sounds	Pre-adapted to thepatient's hearingcharacteristics,a wide selection ofmusical soundsincorporating TinnitusMasking noise (20Hz- 20KHz) digitallyrecorded on minicompact discs in MP3format.	Proprietary dynamicformats of soundsincorporating DynamicTinnitus Mitigationtechnology (20Hz -20KHz) recorded ondigital storage meansthat are played ataudible levels.	Programmable noisespectrum with pre-selection of four noisetypes digitally storedin solid state memory.
Medium	Two mini CDs (butcould be expanded byproviding a variety ofmusic on additionaldiscs).	Four CDs/audio tapes	Solid state memory.
Characteristic	New Device	Predicate DeviceK974501	Predicate DeviceK011364
Operation - continued
Volume control	Yes, user controlledwith warning in theUser InstructionManual stating "Toprevent the possibledamage to yourhearing the volumesetting of the discplayer should not beset at levels whereyou are uncomfortablewith the sound".	Yes, user controlledwith a note statingthat the volumeshould always be setat a low level whenfirst trying any CD.	Yes, user controlledwithin limits pre-programmed by themanaging healthprofessional.
Distribution	To be sold via directand indirect channelsinvolving anappropriately qualifiedhealthcareprofessional.	Currently sold andsupported via mailorder.	The sale and fitting ofthe Siemens CustonTCI will only beconducted through aHearing HealthcareProfessional, such asan audiologist orotolaryngologist.
Components	The components ofthe completeTinniTech ANMPsystem include:Sound files onstorage means(digital mini CDs)A high quality,digital MP3 miniCD player, ofnormalcommercialsupplyUser's Manual	The components ofthe completepredicate devicesystem include:Sound files onstorage means(digital CDs orAudio tapes)A digital CD orAudio Tapeplayer, eitherportable or fixedof normalcommercialsupply or pre-existing in thehome or car.User's Manual (calledWorkbook)	The Siemens CustomTCI is a fully digital,programmable, lowlevel noise generatorthat is available in afull in-the-ear, halfshell, in-the-canal, orhelix shell.User's Manual.
Characteristic	New Device	Predicate DeviceK974501	Predicate DeviceK011364
Audio player device.	The Philips eXpanium401 mini MP3 mini CDplayer with earphonesis supplied byTinniTechSize3.6"L x 4.7" H x1.1" DWeight: 200 g (7.1ounces)Battery: 1 x 1.5V AAAccessories:Earphone	A standard Walkmantype digital player orequivalent player is acommonly usedlistening/deliverydevice.The Sony modelCDFV-15 isrecommended.Size:5.5" x 5.0" x 7/8"Weight: 105 g(3.6 ounces)Battery: 2 x 1.5V AAAccessories:headphones	Not applicable.
Energy delivered	The supplied mini discplayer, the PhilipseXpanium 401 has amaximum poweroutput per channel of5mW.The maximum outputfrom the earphonescould exceed 85 dBA,the OSHA (Standard29CFR 1910.95) 8hour time weightedaverage for theoccupationalworkplace, andtherefore a warningabout setting theplayer volume settingat a comfortable(safe) level is includedin the User's Manualand on the player	No Maximumstipulated orcontrolled. A homestereo system couldbe capable of morethan 200 Wattsoutput.	Maximum output is86dBA which exceedsthe OSHA (Standard29CFR 1910.95) 8hour time weightedaverage for theoccupationalworkplace thereforewarnings are includedin the User's Manual.
Energy used	The supplied mini discplayer, the PhilipseXpanium 401operates from eitherone AA cell or a 110VAC mains adapterprovided with theplayer.	The audio player willutilise mains voltage(1110 VAC) or batteryvoltage (typically upto 9 VDC)	Small hearing aid typebattery.
Characteristic	New Device	Predicate DeviceK974501	Predicate DeviceK011364
Transducer(headphones type)	Use the earphonesprovided with the minidisc player.	Recommended to useeither Radio Shackheadphones PRO-35orSony premiumheadphones orearbuds.	The Siemens CustomTCI is an "in-the-ear"device and isavailable in fourversions:full in-the-ear, halfshell, in the canal, orhelix shell.
Where used	Home use under themanagement of anappropriately qualifiedhealthcareprofessional	Home use	Home use
Safety	The ANMP therapyshould never beundertaken when thetinnitus maskingsounds might preventthe patient fromhearing cues orwarnings of likelyharm or danger.	External low-levelnoise may not beheard due to the factthat the soundwavesare played at audiblelevels to suppressTinnitus
Materials	Typical audio productmaterials such asplastic and diecastmetals.	Typical audio productmaterials such asplastic and diecastmetals.	Typical hearing ailproduct materialssuch as plastics.
Performance	The TinniTech ANMPsystem enables theuser to determinewhether the deliveredtherapy assists in themanagement of theirtinnitus.	The predicate deviceenables the user todetermine whether thesound therapy assiststhem manage theirtinnitus	The predicate deviceenables the end userto determine whetherthe sound therapyassists them tosuppress Tinnitus.
Instructions	The TinniTech ANMPSystem comes with aUser's Guide	The predicate devicecomes with a 23 pageWorkbook

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Treatment management and diagnosis

The TinniTech ANMP System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist, an audiologist, or a licensed hearing aid dealer.

Patients should 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 the TinniTech ANMP treatment.

Risks and warnings for safe use

The maximum output could exceed the occupational workplace OSHA standard 29CFR 1910.95 of 85 dBA. To avoid possible hearing damage the CD player and the User's Manual carry warnings stating that the sounds on the discs should not be played at uncomfortable volume levels.

The CD player carries a label warning against use of the ANMP system if such use prevents the user from hearing sounds warning of danger.

Benefits

Relief from the effects of tinnitus may be provided by the TinniTech ANMP system when used within a tinnitus management program.

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Image /page/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three parallel lines curving upwards, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2003

TinniTech Ltd c/o Lachlan S. James Level 2, 55 Market Street Sydney NSW 2000 Australia

Re: K030791

Trade/Device Name: ANMP (Acoustic Neuro Modulation Protocol) Regulation Number: 21 CFR §874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: February 28, 2003 Received: March 12, 2003

Dear Mr. James:

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 - Lachlan S. James

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) 594-4613. 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,

A. halyi 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

Enclosure

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3.2 Indications for Use

510(k) Number (if known): Device Name: TinniTech ANMP System:

KO30791

Indications for Use:

The TinniTech ANMP System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist, an audiologist, or a licensed hearing aid dealer.

The Tinnitech ANMP System may be used to completely mask and intermittently mask tinnitus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	X
---------------------------------------	---

Over-The-Counter Use
----------------------	--

Signature
(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number	K030791
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Page __ of __

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.