The Peace N Quiet device is indicated for use in the temporary relief of tinnitus symptoms. The device plays customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is for patients who are 18 years or older. This device should only be used with the advice of a physician, audiologist or other healthcare professional.

Device Description

The Peace N Quiet tinnitus device is software as a medical device implemented as a mobile application for patients suffering from tinnitus. The Peace N Quiet tinnitus mobile app can be downloaded from the Apple Store onto a personal Apple iPhone device facilitates a qualified healthcare professional (HCP). i.e., physician or audiologist, to provide professional counseling or education to the patient. The HCPs can direct and assist patients to self-administer customized treatments using the Peace N Quiet tinnitus device.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a device called "Peace N Quiet (0.7.0)", which is a software as a medical device (SaMD) intended for the temporary relief of tinnitus symptoms.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Crucially, the document states: "SUMMARY OF CLINICAL TESTING: Clinical testing was not performed as part of this submission." This means there is no clinical study described in this document to demonstrate the device's performance against acceptance criteria for clinical efficacy or human user performance.

The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical testing (software verification and validation). It does not present acceptance criteria or a study that proves the device meets clinical performance criteria in the way one might expect for a diagnostic or therapeutic AI/ML device that generates specific outputs for classification or prediction.

Therefore, for many of the requested points, the answer will be "Not applicable" or "Not specified in this document" because the submission is not focused on proving clinical effectiveness through a new clinical trial, but rather on demonstrating equivalence based on existing device classifications and non-clinical software testing.

Here's the breakdown based on the request and the provided text:

1. A table of acceptance criteria and the reported device performance:

The document does not specify performance acceptance criteria in terms of clinical outcomes (e.g., reduction in tinnitus severity by X%). Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to the predicate devices and by successfully completing software verification and validation.

The closest to "reported device performance" are the technological characteristics listed in the comparison table, which show it operates similarly to the predicates.

Feature	Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (Peace N Quiet)
Intended Use	Temporary relief of tinnitus symptoms in patients 18 years or older, used with advice of HCP, as part of a tinnitus management program using customized sounds. (Matches predicate K161562 and reference K163094)	Indicated for use in the temporary relief of tinnitus symptoms. Plays customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. Target population 18 years or older, used with advice of physician, audiologist, or other healthcare professional. (Identical to primary predicate)
Output Maximum Volume	85 dB (Matches primary predicate K161562)	85 dB
Output Frequency Range	Within normal human hearing frequency ranges, similar to predicates. (Primary predicate: "Dependent on patient headphones (commercial)"; Reference predicate: 50Hz~15,000Hz)	500 Hz~16,000Hz
Stimuli Type	Provide sound customization for tinnitus masking (Implied: similar functionality/effect to predicates' amplitude-modulated, broadband or sinusoidal sounds). Differences in specific modulation types or noise options are considered not to raise new risks.	Supports Periodic Signal Type (Sine, Triangle, Sawtooth, Square with Amplitude, Frequency, Phase, Duty Cycle), Pseudorandom Type (Random, Pseudorandom), Random Noise Type (White, Pink with Amplitude, Frequency Limits), and Modulation (Amplitude, Frequency, Pulse). Sounds are customized to the patient by a qualified HCP.
Volume Control	Individual volume control per ear of application software, or ability to adjust via personal music player (Matches reference predicate K163094, and conceptually similar to primary predicate K161562 which uses external device volume).	Individual volume control per ear of the application software.
Software Conformance	Adherence to recognized software lifecycle process standard. (Predicate K161562 to IEC 62304:2006)	IEC 62304:2015 Medical device software – Software life cycle processes.

Essentially, the "acceptance criteria" here are that the device is demonstrably substantially equivalent to legally marketed predicate devices, and that its software development conforms to relevant standards for safety and performance (i.e., it is well-engineered and functions as intended without introducing new risks).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No clinical test set or patient data for performance evaluation is described in this submission, as "Clinical testing was not performed as part of this submission." The testing referred to is software verification and validation.

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

Not applicable. As no clinical test set for performance evaluation was involved, no experts were needed to establish ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As no clinical test set for performance evaluation was involved, no adjudication method was relevant.

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:

No. The document explicitly states "Clinical testing was not performed as part of this submission." Therefore, no MRMC study or assessment of human reader improvement was conducted or reported.

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

No. The document explicitly states "Clinical testing was not performed as part of this submission." While the device is "software only," its function is to provide customized sounds for a patient to use with the advice of a healthcare professional as part of a management program. Its performance is relative to its ability to play sounds as intended and match the utility of equivalent predicate devices, not as a standalone diagnostic algorithm. The "testing" primarily involved software verification and validation per IEC 62304:2015.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the software verification and validation testing, the "ground truth" would be the software requirements specifications and design documents. The tests verify that the software functions as designed and meets these specifications. There is no clinical or biological "ground truth" (like pathology or outcomes data) established for device performance in this submission.

8. The sample size for the training set:

Not applicable. The document does not describe a machine learning model that requires a training set. The "Peace N Quiet" device is described as "software as a medical device" that plays customized sounds. It's not presented as an AI/ML diagnostic or predictive algorithm that learns from data.

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

Not applicable. As there is no described training set for a machine learning model, the establishment of ground truth for such a set is not relevant.

Summary

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February 27, 2024

PNQ Health % Alexia Haralambous Senior Principal Ram+ 2251 San Diego Avenue Suite B-257 San Diego, California 92110

Re: K233435

Trade/Device Name: Peace N Quiet (0.7.0) Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: January 29, 2024 Received: January 29, 2024

Dear Alexia Haralambous:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K233435

Device Name

Peace N Quiet (0.7.0)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

DATE PREPARED

February 23, 2024

MANUFACTURER AND 510(k) OWNER

PNQ Health, Inc. 110 Cheshire Lane, Ste 385 Minnetonka, MN 55305 Telephone: +1 (651) 280-7624 Official Contact: Kurtis Goos, Chief Executive Officer

REPRESENTATIVE/CONSULTANT

Alexia Haralambous, MS, RAC Hrishikesh Gadagkar, Ph.D. ROM+ 2251 San Diego Ave, Suite B-257 San Diego, CA 92110, USA Telephone: +1 (267) 778-5114 Email: aharalambous@rqmplus.com hgadagkar@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name: Peace N Quiet Common Name: Tinnitus masker Regulation Number: 21 CFR 874.3400 Class: II Product Code: KLW Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1), Division of Dental and ENT Devices (DHT1B) Review Panel: Ear, Nose, and Throat

PREDICATE DEVICE IDENTIFICATION

The Peace N Quiet device is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	PrimaryPredicate	ReferenceDevice
K161562	Sound Options Tinnitus Treatment / Sound OptionsTinnitus Treatments, Inc.	✓
K163094	TinniLogic Mobile Tinnitus Management Device /Jiangsu BetterLife Medical, Ltd.		✓

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DEVICE DESCRIPTION

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

PNO Health. Inc. believes that the Peace N Ouiet device is substantially equivalent to the predicate device based on the information summarized here:

The subject device has the same intended use as the primary predicate, the Sound Options Tinnitus Treatment (K161562), i.e., software intended for the temporary relief of tinnitus symptoms, with a target population of patients who are 18 years or older and suffering from tinnitus. The subject device shares several technological characteristics with the primary predicate (K161562). Both are software-only medical devices that provide audio sound outputs customized to the patient to mask tinnitus as part of a tinnitus management program, and both systems are compatible with pre-specified earbuds (non-medical device). The subject device differs in that its sounds are customized to the patient by a qualified HCP, whereas the primary predicate (K161562) has sounds that are primarily customized by the device manufacturer (Sound Options Tinnitus Treatments, Inc.) in addition to the HCP. Both allow for physical volume control and maintain the same output maximum. 85 dBA, with similar output frequency ranges that fall within normal human hearing frequency ranges. In addition, both utilize primarily amplitude-modulated stimuli. The primary predicate (K161562) relies on broadband frequency sound prescribed and customized to the patient by the HCP, whereas the subject Peace N Quiet device includes frequency modulation (in addition to amplitude modulation) that is customized to the patient within the device by a qualified HCP. The periodic signal types offered by the subject device provide additional options for HCP and patient customization of timitusmatched sounds. To allow the HCP and patient to further tailor the customized sounds to match the patient's perceived tinnitus, the primary predicate (K161562) uses broadband noise adjustments, while the subject device offers the user the option of additive pseudorandom noise adjustments such as white or pink noise. Both sets of options offer the user ways to tailor the customized sounds to come as close as possible to the patient's perceived tinnitus, with the subject device offering a higher number of adjustable parameters as compared to the primary predicate.

The TinniLogic Mobile Tinnitus Management Device (K163094) device was used as a reference device to support the technology of temporary relief of tinnitus symptoms through customized

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masking sounds. The reference device (K163094) utilizes sinusoidal amplitude-modulated sounds with a combination of narrow-band noise, broad-band noise, and other types of noise such as white noise and natural sounds, to allow the user ways to tailor the customized sounds. These options differ slightly from the additive noise options of the subject device, but both the reference device (K163094) and primary predicate noise options offer the user a variety of options intended to allow them to match the patient's perceived tinnitus as closely as possible. These differences do not present new or modified risks, and therefore they do not raise different questions of safety and effectiveness. This information is summarized in the following table.

	Subject Device:Peace N Quiet	Primary Predicate:Sound Options TinnitusTreatment (K161562)	Reference Device:TinniLogic MobileTinnitus ManagementDevice (K163094)
Indications forUse	The Peace N Quiet deviceis indicated for use in thetemporary relief oftinnitus symptoms. Thedevice plays customizedsounds to relieve patientssuffering from tinnitusand can be used in atinnitus managementprogram. The targetpopulation is for patientswho are 18 years orolder. This device shouldonly be used with theadvice of a physician,audiologist or otherhearing healthcareprofessional.	The device, SoundOptions TinnitusTreatment, version SO2.0, is for the temporaryrelief of tinnitussymptoms. The device is asoftware application thatembeds sounds andspectral content intomusic to relieve patientssuffering from tinnitusand can be used as partof a tinnitus managementprogram for adults 18years and older. Thedevice is for prescriptionuse by a physician,audiologist or otherhealthcare professional.	The TinniLogic MobileTinnitus ManagementDevice is indicated foruse in the temporaryrelief of tinnitussymptoms. The device is aplayer to play customizedsounds and displayprofessional counselingor education to relievepatients suffering fromtinnitus and can be usedin a tinnitus managementprogram. The targetpopulation is adults (18years or older). This is amedical device andshould only be used withthe advice of a physician,audiologist or otherhearing healthcareprofessional.
Target Population	Adult (18 years andolder) tinnitus patients	Adult (18 years andolder) tinnitus patients	Adult (18 years andolder) tinnitus patients
Use Environment	At-home and healthcarefacilities	At-home and healthcarefacilities	At-home and healthcarefacilities
Patient Medium	Software only	Software only	Hand-held audio devicefor use with earphones
ProfessionalCounseling/Education	Guidance is provided viathe HCP and prompts onthe software app	Guidance is provided viathe HCP	Guidance is provided viathe HCP as well asprompts on the providedtablet
DeviceComponents	Peace N Quiet Software	● Sound Optionssoftware only device,SO 2.0	● TinniLogic MobileTinnitus ManagementDevice with softwarepre-installed
	Subject Device:Peace N Quiet	Primary Predicate:Sound Options TinnitusTreatment (K161562)	Reference Device:TinniLogic MobileTinnitus ManagementDevice (K163094)
			Earphones Accessories (adaptor, power cable, USB cable)
Sounds	Sounds customized to thepatient by a qualifiedhealth care professional.	Sounds customized bySound Options TinnitusTreatments, Inc.(manufacturer)Customized music tracksare available to patientsby download or on CD.	Sounds customized to thepatient by a qualifiedhealthcare professional.
Stimuli Type	Periodic Signal Type (Sine, Triangle, Sawtooth, Square) Amplitude Frequency Phase Duty Cycle (for square type only) Pseudorandom Type (Random, Pseudorandom) Random Noise Type (White, Pink) Amplitude Frequency Limits (Low & High) Modulation Amplitude (A signal played at various amplitudes) Frequency (A signal played at various frequencies) Pulse (A signal that is pulled on and off)	Amplitude-modulated tinnitus matching Broadband frequency sound Broadband noise	Sinusoidal amplitude modulated (SAM) tinnitus pitch matched sounds Narrow-band noise centered at the tinnitus frequency Broad-band noises Pure tone White noise Natural sounds Relax sounds
Volume Control	Individual volume controlper ear of the applicationsoftware	Patients are to listen tothe sound therapy at acomfortable volume level	Individual volume controlper ear of the applicationsoftware
	Subject Device:Peace N Quiet	Primary Predicate:Sound Options TinnitusTreatment (K161562)	Reference Device:TinniLogic MobileTinnitus ManagementDevice (K163094)
		by adjusting the volumecontrol on their personalmusic-playing device.	Physical volume controls
		Safe levels weredetermined through benchtesting for each of therecommendedcommercial deviceoptions described in theuser manuals.
Maximum Output	85 dB	85 dB	90 dB
Output Frequency	500 Hz~16,000Hz	Dependent on patientheadphones (commercial)	50Hz~15,000Hz
PerformanceTesting	● IEC 62304:2015	● IEC 62304:2006	● IEC 60601-1● IEC 60601-1-2

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SUMMARY OF NON-CLINICAL TESTING

Software verification and validation testing was performed per IEC 62304:2015 Medical device software – Software life cycle processes to demonstrate safety and performance based on current industry standards.

SUMMARY OF CLINICAL TESTING

Clinical testing was not performed as part of this submission.

CONCLUSION

Based on the verification and validation testing performed in accordance with IEC 62304:2015, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The Peace N Quiet device is demonstrated to be substantially equivalent to the predicate device.

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.