The NAS-1000 System is a medical acoustic system intended as an adjunct to standard clinical practice for use in non-invasively monitoring, detecting, recording and displaying acoustic signals in the brain. It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.

Device Description

The NAS-1000 System is a non-invasive, non-energy emitting device indicated for monitoring and recording of acoustic signals from the brain. The earbud passively receives the acoustic signal from the brain and the result is graphically displayed as an acoustic waveform on the monitor (NAS-1000M).

The NAS-1000 System consists of two components: a non-sterile, disposable, single patient use Headset (NAS-1000H) with four different sized earbuds (XS, S, M, L), and a tablet-based Monitor (NAS-1000M) which contains the software (NAS-1000S).

AI/ML Overview

The provided text describes the Neuro Assessment System (NAS-1000) and its substantial equivalence to a predicate device, the 3M™ Littmann® Electronic Stethoscope, Model 3200 (K083903). While it details non-clinical and clinical testing, it does not explicitly provide an acceptance criterion table with reported device performance or information typically found in a comparative effectiveness study with AI assistance.

Here's a breakdown of the information available and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding performance metrics. Instead, it describes general findings from phantom bench testing and clinical testing on volunteers. The core comparison is framed around "substantial equivalence" to the predicate device, K083903.

The document states:

Phantom Bench Testing: "The NAS-1000 System and the 3M Littmann e-Stethoscope performed comparably and were able to graphically display the simulated systolic pulse from the phantom."
Clinical Testing: "The study demonstrated the ability of the NAS-1000 System to detect and generate waveforms from the brain to provide a tool for monitoring brain acoustic signals / sounds over various time intervals." and "The tablet outputs demonstrate the ability of the NAS-1000 System to display brain acoustic signals / sounds of in the volunteers based on the analysis of waveform data."

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

Sample Size for Test Set: 50 volunteers.
Data Provenance: The document states "A performance testing study of the NAS-1000 System was conducted on volunteers" and "A total of 50 volunteers were measured and monitored." This indicates a prospective clinical study on human subjects, but the country of origin is not specified. It is implied to be a direct collection for the device's validation.

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

This information is not provided in the document. The study aimed to demonstrate the device's ability to detect and generate waveforms from the brain, implying the ground truth was the actual detection of acoustic signals rather than a diagnostic interpretation by experts. The device is for "monitoring, detecting, recording and displaying acoustic signals," not for providing a diagnosis based on an expert's assessment.

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

This information is not provided and is not applicable given the reported nature of the study as a technical performance validation rather than a diagnostic accuracy study requiring expert adjudication of ground truth labels.

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

An MRMC comparative effectiveness study was not conducted or described. The NAS-1000 System is presented as an acoustic monitoring device that displays waveforms, not an AI-powered diagnostic tool that assists human readers in making diagnoses. Thus, there is no mention of human reader improvement with AI assistance.

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

The device itself is a standalone system for monitoring and displaying acoustic signals. The clinical testing described directly assesses the system's ability to "detect and generate waveforms" and "display brain acoustic signals," which aligns with a standalone performance assessment of the device's core functionality.

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

The ground truth for the clinical study was the presence and characteristics of brain acoustic signals/sounds in volunteers. The study demonstrated the device's ability to detect and generate waveforms from these signals. For the phantom bench testing, the ground truth was a "simulated systolic pulse" generated by a peristaltic pump, and the device's output was compared to this known input signal.

8. The sample size for the training set

This information is not provided. The document focuses on regulatory submission and doesn't detail the development and training of potential machine learning models, if any are employed beyond signal processing. Given the device's description as a system for monitoring, detecting, recording, and displaying acoustic signals, it's more likely relying on signal processing algorithms rather than a trained AI model in the typical sense that would require a large training set for diagnostic purposes.

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

This information is not provided as the concept of a "training set" for an AI model is not discussed in the context of this device's validation.

Summary

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March 8, 2018

HeadSense Medical Inc. % Kit Cariquitan Chief Regulatory Officer Experien Group. LLC 224 Airport Parkway Suite 250 San Jose, California 95110

Re: K172892

Trade/Device Name: Neuro Assessment System NAS-1000 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: QBE Dated: September 21, 2017 Received: September 22, 2017

Dear Kit Cariquitan:

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.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Kit Cariquitan

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172892

Device Name Neuro Assessment System NAS-1000

Indications for Use (Describe)

The NAS-1000 System is a medical acoustic system intended as an adjunct to standard clinical practice for use in noninvasively monitoring, detecting, recording and displaying acoustic signals in the brain. It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.

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) Notification K172892

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

HeadSense Medical Inc. 520 S. Main Street, Suite 2457 Akron, OH 44311 USA Phone: 234-678-3888

Company Contact Person:

Richard A. Lotti Executive Chairman and CEO HeadSense Medical Inc. USA Phone: 408-202-0637 Email: richard@head-sense-med.com

Regulatory Correspondent/Contact Person:

Kit Cariquitan Consultant, HeadSense Medical Inc. Chief Regulatory Officer Experien Group, LLC 11440 W Bernardo Ct., Ste. 253 San Diego, CA 92127 USA Phone: 408-656-5985 Email: kitc@experiengroup.com

Date Prepared: February 5, 2018

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

Neuro Assessment System, NAS-1000

Generic/Common Name:

Electronic Stethoscope

Classification:

21 CFR§870.1875

Product Code:

QBE

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PREDICATE DEVICE(S) [807.92(a)(3)]

The predicate device to support substantial equivalence of the NAS-1000 System is the 3M™ Littmann® Electronic Stethoscope, Model 3200 cleared under K083903.

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

Feature	HeadSense Neuro Assessment System,NAS-1000(K172892)	3MTM Littmann® ElectronicStethoscope, Model 3200,K083903(Primary predicate device)	Analysis of Differences
Regulation/Classification	21 CFR §870.1875	21 CFR §870.1875	No difference.
Regulation Name	Stethoscope, Electronic	$tethoscope, Electronic	No difference.
Classification	II	II	No difference.
Product Code	DQD	DQD	No difference.
Indications for use	The NAS-1000 System is a medicalacoustic system intended as an adjunct tostandard clinical practice for use in non-invasively monitoring, detecting,recording and displaying acoustic signalsin the brain. It is used for any subjectundergoing a physical examination andintended only for medical assessmentpurpose in a clinic or hospital.	3M™ LITTMANN®ELECTRONIC STETHOSCOPEMODEL 3200 is intended formedical diagnostic purposes only. Itmay be used for the detection andamplification of sounds from theheart, lungs, arteries, veins, andother internal organs with the use ofselective frequency ranges. It can beused on any person undergoing aphysical assessment.	Proposed intended use isthe same as K083903.The subject device and thepredicate device areintended for monitoring,detecting and recordingacoustic signals / soundselectronically.
Anatomical Location	Brain	Heart, lungs, arteries, veins, andother internal organs with the use ofa selective frequency.	Similar to K083903. Thepredicate device may beused for other internalorgans (i.e., brain). Thesubject device is to be usedfor the brain only.
Environment of use	Clinic, treatment center or hospital.	Clinic or hospital.	No difference.

Device Description	The NAS-1000 System is a non-invasive, non-energy emitting device indicated for monitoring and recording of acoustic signals from the brain. The earbud passively receives acoustic signals from the brain and the result is graphically displayed as an acoustic waveform on the monitor (NAS 1000M).The NAS-1000 System consists of two components: a non-sterile, disposable, single patient use Headset (NAS-1000H) with four different sized earbuds (XS, S, M, L), and a tablet-based Monitor (NAS-1000M) which contains the software (NAS-1000S).	The 3MTM Littmann® Electronic Stethoscope, Model 3200 is a healthcare device that picks up sounds of the heart, arteries, veins, lungs and other internal organs with the use of selective frequency ranges. After amplification and filtering, the sounds are transferred to the user's ears via an active speaker and passive sound tubes.The Model 3200 can also exchange audio data with a personal computing device (PC) using wireless Bluetooth link.The user interface includes a 5-button keypad and an LCD display. Sound processing is carried out with the aid of a digital signal processor. The Model 3200 does not incorporate any off-the-shelf (OTS) software. The Model 3200 operates on one (1) AA alkaline, lithium, or NiMH battery.	Similar to K083903. Both systems passively obtain acoustic signals / sounds generated by the patient's organ using a microphone.Both systems process the acoustic signals / sounds and present them to the user.The 3M Littmann Electronic Stethoscope presents the sounds in the form of audio signal to the user. The NAS-1000 System provides the acoustic signals / sounds in the form of a graphical (visual) output to the user.
Sterilization Method	Non-sterile	Non-sterile	No difference.
Biocompatible Blood, Body and Fluid Contacting Materials	Skin contact only	Skin contact only	No difference.
Power Source
Source Type	Battery	Battery	No difference.
Battery Type	Lithium ionCR 2032 Lithium IonCoin Cell (Headset)Lithium Ion, 4000 mAh(Tablet)	One AA battery	The systems use differentbattery types sufficient foroperation life for intendeduse.
Battery Operation Time	Up to 260 Hrs (Headset)Up to 74 Hrs (tablet)	50-60 Hours	The systems have similaroperation times and havesufficient operation life forintended use.
Functional
Binaural Headset	Yes	Yes	No Difference.
Chest-Piece	No	Yes	The NAS-1000 Systemutilizes an earbud designoptimized for use in thehead not the chest.
Sound Processing	Digital Signal Processor	Digital Signal Processor	No Difference.
Display Function	Yes	Yes	No Difference.
Display of Waveform	3 views of total energy from spectrogram(vertical axes: 0-15 Hz, 0-25 Hz, and 0-45Hz; horizontal axis: time (6 secondintervals for all charts)	Can Toggle between phonogramand spectrogram (vertical axes: 0-500 Hz, horizontal axis: time).	Both display axes forfrequency (Hz) and time(sec). The NAS-1000System displaysfrequencies specific toacoustic signals /soundsgenerated in the brain whilethe 3M Littmann displayssounds for pulmonary,cardiovascular, or generaluse.
Signal to Noise Ratio	23 dBv	20 dBv	The NAS-1000 Systemsignal to noise ratio is 3dBv higher than the 3MLittmann. Since the NAS-1000 System has ahigher signal to noise ratiothen the 3M Littmann, theNAS-1000 System wouldbe expected to be at least asgood as the 3M Littmann atdistinguishing signal fromnoise.
Display Type	LCD	LCD	No Difference.
Select Filter	There is no selectable filter for the NAS-1000 System.	Bell (20-1000 Hz)Diaphragm (20-2000 Hz)Extend range (50-500 Hz)	The NAS-1000 Systemdesign records pre-specified frequencies (0-15Hz, 0-25 Hz, 0-45 Hz) inthe brain. The 3MLittmann filters are specificfor frequency values forpulmonary, cardiovascularor general use.
Detect and DisplayHeart Rate Function	N/A	Yes	The NAS-1000 Systemdisplays acoustic signals /sound waveforms from thebrain and does not detect ordisplay heart rate function.
Detect and Display HeartRate Range	N/A	30-199 bpm	The NAS-1000 Systemdisplays acoustic signals /sounds from the brain and
			does not detect or displayheart rate function.
Record and PlaybackFunction	N/A	Yes	Not a required feature.
Number of Record andPlayback Sounds	N/A	Save up to twelve, 30-second soundtracks;Latest 12 sound tracks for playback.	Not a required feature
Sound Amplifier	N/A	Yes, up to 24X	No sound is outputted
Volume Control	N/A	Yes	No sound is outputted
Volume Control Level	N/A	1-9 level	No sound is outputted
AutomaticPower Off	Yes	Yes	The tablet automaticallypowers off after 10minutes.
Monitor BatteryLife Function	Yes	Yes	Monitored on tablet userinterface
Monitor BatteryLife Degrees	100 (percentage)	4 degrees	The tablet displays batterylife in increments of 1%,the Littman has anindicator for each ¼ ofremaining life (for the 3MLittmann, each indicator istermed a "degree": 4indicators represents fullcharge, 1 indicatorrepresents 1/4 charge, etc.,)
Sound Track TransferFunction	Yes	Yes	Wav files saved
Sound Track TransferInterface	USB Cable	Bluetooth	Wav files may betransferred from the tabletvia a USB cable

Comparison of NAS-1000 System to Predicate Device

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510(k) SUMMARY

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SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the NAS-1000 System is substantially equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the NAS-1000 System is substantially equivalent to the predicate device.

PERFORMANCE DATA [807.92(b)]

All necessary nonclinical testing was conducted on the NAS-1000 System to support a determination of substantial equivalence to the predicate device.

[807.92(b)(1)] Nonclinical Testing Summary:

The nonclinical bench testing included:

. Performance bench and functional testing
. Software testing
Biocompatibility
. Electrical Safety and Electromagnetic Compatibility testing

Phantom Bench Testing was also performed to verify that the NAS-1000 System is able to monitor, detect, record and displaying an acoustic signal / sound. A Cranial Phantom Head test model was designed and used during this testing to compare the NAS-1000 System and the predicate device. A representative cyclic acoustic signal/sound was generated using a peristaltic pump in the phantom bench test model and the waveforms were recorded and compared for both the NAS-1000 System and the predicate to the known input signal from the phantom bench test model. The NAS-1000 System and the 3M Littmann e-Stethoscope performed comparably and were able to graphically display the simulated systolic pulse from the phantom. The "simulated systolic pulse" refers to the pulsations generated by the motor of the phantom bench test.

The collective results of the nonclinical testing demonstrate that the device meets its performance requirements and does not raise different questions of safety or effectiveness for measuring acoustic signals in the brain or presenting information to the clinician when compared to the predicate device.

[807.92(b)(2)] Clinical Testing Summary:

A performance testing study of the NAS-1000 System was conducted on volunteers to validate the measurement of acoustic data collected from recordings of brain acoustic signals / sounds. The study demonstrated the ability of the NAS-1000 System to detect and generate waveforms from the brain to provide a tool for monitoring brain acoustic signals / sounds over various time intervals.

A total of 50 volunteers were measured and monitored.

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510(k) SUMMARY

NAS-1000 System recording sessions were conducted for 20 minutes continuously with each volunteer, and raw data was passively recorded by the monitor software. The data was then analyzed retrospectively to display on the tablet in three frequency bands (0-15 Hz, 0-25 Hz, 0-45 Hz), and also converted and displayed the output into a 2D waveform. The tablet outputs demonstrate the ability of the NAS-1000 System to display brain acoustic signals / sounds of in the volunteers based on the analysis of waveform data.

CONCLUSIONS [807.92(b)(3)]

In summary, the NAS-1000 System and the 3M Littmann have the same intended use and similar technological characteristics. Differences in the technological characteristics have been evaluated and supported with appropriate testing. The collective performance testing including the phantom bench testing and clinical testing on volunteers demonstrate substantial equivalence to the predicate device. The NAS-1000 Systems meets its performance requirements and the differences in technological characteristics do not raise different questions of safety or effectiveness for displaying acoustic signals / sounds from the brain or presenting information to the clinician when compared to the predicate device.

SUMMARY

The NAS-1000 System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.