The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, documentation and diagnosis of auditory and hearing related disorders. The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.

The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.

Device Description

The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.

Novus features a touch-screen display and user-friendly software in a compact hardware design. Novus can be purchased with various licenses allowing you to perform different hearing screening tests.

Novus uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp", of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity.

The EEG is processed and analyzed automatically using the Novus's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned.

Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.

Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.

Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.

The Novus consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports Bluetooth® communication with a label printer for the purpose of printing screening results.

AI/ML Overview

This document does not contain an acceptance criteria table or a study proving the device meets specific acceptance criteria in the format requested. The document is a 510(k) premarket notification letter from the FDA to Grason-Stadler Inc. for their GSI Novus device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical trial results or specific performance metrics against pre-defined acceptance criteria.

However, based on the provided text, I can extract information related to the device's intended use, general performance claims, and the type of non-clinical testing performed to support its safety and effectiveness.

Here's an attempt to answer your questions based only on the provided text, noting where information is explicitly not present:

Acceptance Criteria and Device Performance Study for GSI Novus (K172403)

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

The document does not provide a table of explicit acceptance criteria with corresponding device performance metrics. Instead, it asserts that the GSI Novus meets performance specifications by complying with international standards and through non-clinical design verification and validation. The "reported device performance" is primarily qualitative, stating that the device is "safe and effective" and that its performance characteristics are comparable to predicate devices.

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

The document explicitly states: "No clinical tests were performed" and "Summary of Clinical Testing: Not applicable. Not required to establish substantial equivalence." Therefore, there is no test set sample size, data provenance, or information on retrospective/prospective studies from clinical testing. The "data collection" mentioned in Phase 2 refers to data collected during non-clinical verification and validation activities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical tests were performed and no "test set" in the context of human data was used to establish ground truth for clinical performance, this information is not applicable and not provided.

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

Not applicable, as no clinical test set was used for ground truth establishment.

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

Not applicable. The document states "No clinical tests were performed." Furthermore, the GSI Novus is described as an auditory testing device with an automatic response detection algorithm ("Novus's response detection algorithm"), implying it functions as a standalone diagnostic aid rather than an AI assistance tool for human "readers" (in the typical sense of image interpretation).

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

Yes, the device relies on an automated analysis algorithm. The description mentions:

"The EEG is processed and analyzed automatically using the Novus's response detection algorithm."
"When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned."
"The detailed information about the validation and verification of PASS/REFER algorithms for the OAE and ABR modules is provided in the GSI Novus Manual, e.g., PASS/REFER Criteria, Sensitivity and Specificity etc."

This indicates that a standalone algorithm performance was assessed for the automated PASS/REFER results during the non-clinical design verification and validation activities, although specific performance metrics (like sensitivity, specificity) are referenced as being in the manual but not provided in this document.

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

For the non-clinical verification and validation of the "PASS/REFER algorithms," the "ground truth" would have been established by comparing the algorithm's output to expected or reference values derived from recognized audiological principles and potentially a "gold standard" reference measurement or simulation. The document mentions "Phase 3 then went into the algorithm descriptions for each TEOAE, DPOAE and ABRIS measurements modes," implying that the ground truth for validating the algorithms themselves would be based on established audiological standards and the device's ability to accurately detect "responses" or "no responses" against these standards. Specifics of how this "ground truth" was established (e.g., against a known simulated signal, against a predicate device's output, or against expert analysis of raw data) are not detailed here.

8. The sample size for the training set

The document does not mention a "training set" or "training data" in the context of machine learning, nor does it specify any sample size for such a set. Given the context of a 510(k) for an audiometer with an automated algorithm, it's possible the algorithm logic was developed based on established audiological principles and signal processing, rather than a large-scale data training approach commonly associated with AI/ML.

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

Not applicable, as no training set is described or referenced in the document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 20, 2017

Grason-Stadler Inc. Amy Yanta Director of Regulatory Affairs 10395 West 70th Street Eden Prairie, MN 55344

Re: K172403

Trade/Device Name: GSI Novus Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: August 9, 2017 Received: August 9, 2017

Dear Amy Yanta:

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.

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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 contact the Division of Industry and Consumer Education (DICE) 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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.

Srinivas Nandkumar -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K172403

Device Name GSI Novus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in light blue on the left. To the right of the sound wave is the company's acronym "gsi" in bold, black letters. Below the acronym is the full company name, "Grason-Stadler," in a smaller, sans-serif font.

Section 5: 510(k) Summary as required by 21 CFR 807.92.

Administrative Information

Submitter: Grason-Stadler Inc. 10395 West 70th Street Eden Prairie, MN 55344 Tel: 952-947-6097 Fax: 952-278-4401
Contact Person: Amy Yanta Director of Regulatory Affairs 10393 West 70th Street Eden Prairie, MN 55344 952-947-6097 amyy@diagnostic-group.us

Date Summary Prepared: August 7, 2017

Device Identification

Trade Name: Novus Common Name: otoacoustic emission device/evoked response auditory stimulator and measurements Device Classification Name: Audiometer/Stimulator, Auditory, Evoked Response Device classification: Class II Panel: Ear Nose & Throat / Neurology Classification Regulation: 874.1050/882.1900 Product Code: EWO/GWJ

Predicate Device 1: Titan (with DPOAE440 and ABRIS440), cleared on 05/05/2011 via K103760 Predicate Device 2: Titan (with TEOAE440), cleared on 06/20/2013 via K130795

Device Description

The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.

Novus features a touch-screen display and user-friendly software in a compact hardware design. Novus can be purchased with various licenses allowing you to perform different hearing screening tests.

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Image /page/4/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in blue, followed by the letters "gsi" in bold, black font. Below the letters, the words "Grason-Stadler" are written in a smaller, sans-serif font, also in black. The logo is clean and modern, reflecting the company's focus on technology and innovation in the field of audiology.

Device Intended Use

The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.

Technological Characteristics

A comparison between the new and predicate devices shows that the technological characteristics and indications for use are equivalent. The device employs similar technology to accomplish the same tasks as the predicates. A detailed table is provided below.

Description	Titan with TEOAE440 (K130795)	Novus
Type	Audiometer	Audiometer
Regulation Number	21 CFR 874.1050(otoacoustic emission device)	21 CFR 874.1050(otoacoustic emission device)
Classification Product Code	EWO	EWO
Regulatory Class	Class II	Class II
Indications for Use	The Titan with TEOAE440 is intendedfor use in the audiologic evaluationand documentation of ear disorders	The GSI Novus is intended tobe used for the measurementand automated analysis of
	using Transient Evoked OtoacousticEmissions.The target population for Titan withTEOAE440 includes all ages.	auditory evoked responses(auditory brainstemresponses, ABR) and/orotoacoustic emissions(distortion product, DPOAEand transient evoked, TEOAE).These measures are useful inthe screening evaluation,identification, documentationand diagnosis of auditory andhearing related disorders.The auditory evoked response(ABR) measurement isintended for newborns andinfants up to 6 months of age.The otoacoustic emissions(DPOAE and/or TEOAE)measurement is intended foruse in patients of all ages.The GSI Novus is intended tobe used by a healthcareprofessional such as an ENTdoctor, nurse or audiologist orby a trained technician underthe supervision of aprofessional. The device isintended to be used in ahospital, clinic, or other facilitywith a suitable quiet testingenvironment.Intended use differs due tothe device encompassing allfunctions into one device.
Target Population	The devices are suitable for allpopulations including new-borninfants	The device are suitable for allpopulations including new-born infants
Intended User	The Titan System is to be used bytrained personnel only such asaudiologists, ENT surgeons, doctors,hearing healthcare professionals orpersonnel with a similar level ofeducation.	To be used by trainedpersonnel only such asaudiologists, ENT surgeons,doctors, hearing healthcareprofessionals or personnelwith similar level of education.(or trained user withsupervision of a professional)
TEOAE Stimulus
Frequency Range	500 to 5500Hz	500 to 5500Hz
Stimuli Type	Non-Linear and LinearShort duration signal (Click)According to IEC 60645-3	Non-Linear and LinearShort duration signal (Click)According to IEC 60645-3
Level	30 to 90 dB peSPL	30 to 90 dB peSPL
Level Step	1 dB SPL	1 dB SPL
Transducer	Dedicated OAE Probe	Dedicated OAE Probe
Probe Detection	Auto detection	Auto detection
Recording
A/D Resolution	24 bit	24 bit
Artifact Reject System	0 -> +60 dB SPL or off	0 -> +60 dB SPL or off
Automatic test with displayof PASS-REFER	Yes	Yes

Equivalence Predicate Chart 1:

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Image /page/5/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in blue, followed by the letters "gsi" in bold, black font. Below the letters, the words "Grason-Stadler" are written in a smaller, lighter font.

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Image /page/6/Picture/1 description: The image shows the logo for Grason-Stadler. The logo features a stylized letter 'g' with three curved lines emanating from it, followed by the letters 'si' stacked on top of the words 'Grason-Stadler'. The letter 'g' and the letters 'si' are in black, while the curved lines are in blue.

Equivalence Predicate Chart 2:

	Titan (K103760)		Novus
Description	With ABRIS440	With DPOAE440	With ABRIS	With DPOAE
Type	Auditory BrainstemResponse -Audiometricequipment	Audiometer	Auditory BrainstemResponse -Audiometricequipment	Audiometer
RegulationNumber	21 CFR 882.1900(Evoked responseauditorystimulator)	21 CFR 874.1050(otoacousticemission device)	21 CFR 882.1900(Evoked responseauditorystimulator)	21 CFR 874.1050(otoacoustic emissiondevice)
ClassificationProduct Code	GWJ	EWO	GWJ	EWO
RegulatoryClass	Class II	Class II	Class II	Class II
Indications forUse	The Titan withABRIS440 isintended for use inthe audiologicevaluation anddocumentation ofear and nervedisorders usingauditory evokedpotentials from theinner ear, theauditory nerve andthe brainstem.	The Titan withDPOAE440 isintended for use inthe audiologicevaluation anddocumentation ofear disorders usingDistortionProductOtoacousticEmissions.	The GSI Novus isintended to be usedfor the measurementand automatedanalysis of auditoryevoked responses(auditory brainstemresponses, ABR)and/or otoacousticemissions (distortionproduct, DPOAE andtransient evoked,TEOAE). Thesemeasures are useful inthe screeningevaluation,identification,documentation anddiagnosis of auditory	The GSI Novus isintended to be usedfor the measurementand automatedanalysis of auditoryevoked responses(auditory brainstemresponses, ABR)and/or otoacousticemissions (distortionproduct, DPOAE andtransient evoked,TEOAE). Thesemeasures are useful inthe screeningevaluation,identification,documentation anddiagnosis of auditory
			and hearing related	and hearing related
			disorders.The auditory evoked	disorders.The auditory evoked
			response (ABR)measurement is	response (ABR)measurement is
			intended for newbornsand infants up to 6	intended fornewborns and infants
			months of age. The	up to 6 months of age.
			otoacoustic emissions(DPOAE and/or	The otoacousticemissions (DPOAE
			TEOAE) measurementis intended for use in	and/or TEOAE)measurement is
			patients of all ages.The GSI Novus is	intended for use inpatients of all ages.
			intended to be used by	The GSI Novus is
			a healthcare	intended to be used
			professional such as anENT doctor, nurse or	by a healthcare
			audiologist or by a	professional such asan ENT doctor, nurse
			trained technicianunder the supervision	or audiologist or by a
			of a professional. Thedevice is intended to	trained technicianunder the supervision
			be used in a hospital,clinic, or other facility	of a professional. Thedevice is intended to
			with a suitable quiettesting environment.	be used in a hospital,clinic, or other facility
				with a suitable quiettesting environment.
			Intended use differsdue to the device
			encompassing all	Intended use differs
			functions into one	due to the device
			device.	encompassing all
				functions into one
				device.
Target	Children and	The patient group	Children and newborn	The patient group
Population	newborn	includes all ages		includes all ages and
		and sexes.		sexes.
Anatomical	Examination of Ear	Examination of Ear	Examination of Ear and	Examination of Ear
Sites	and hearing nerves		hearing nerves
Safety	IEC 60601-1	IEC 60601-1	IEC 60601-1	IEC 60601-1
Standards
Performance	IEC 60645-7	IEC 60645-6	IEC 60645-7	IEC 60645-6
standard
Device Type	Screening device	Screening and	Screening and	Screening and
	(PASS/REFER) result	diagnostic	diagnostic device	diagnostic device
			(PASS/REFER) result	(PASS/REFER) result
System	1 -channel ABR		1 -channel ABR system
Configuration	system operated		operated through a
	through a handheld		handheld base unit.
	base unit. The		The
	base unit can be
	operated stand
	alone or PCcontrolled throughUSB or Bluetooth.		base unit can beoperated as stand-alone device.This allows the freedom of flexibility.The data can be transferred to the PC via USB port for secure transmission.
DisplayInformation	PASS/REFER status, indicated with value between 0 and 100% where 100% indicates a pass. EEG peak or RMS value, rejection status, residual noise and what transducer(s) are detected.		Noise status, detected transducer, artifact %, PASS/REFER status.This creates simplicity for user use.
Stimulus	Click and Chirps	2 pure tones	Click and Chirps	2 pure tones
Electrodequality check	YES		YES
ImpedanceTest	Before recording: Electrode impedance is measured if they are above 10kOhm, below 10 kOhm or below 3 kOhm.		Similar impedance test; acceptable impedance <40kOhm.Below <40kOhm is acceptable value and one test value provides quicker values to reference.
Binauralscreening	YES		YES
Pre-amplifierchannels	1		1
Stimulus rate	90/s		90/s
Pre-amplifierGain	64 dB (fixed) + 64dB (Variable)		64 dB (fixed) + 64dB (Variable)
Stimulus Level	30,40 and 45dB HL	30 dB SPL to 80 dBSPL	30,40 and 45dB HL	30 dB SPL to 80 dB SPL
Masking	None		None
Transducers	Titan Probe (mono)Stereo headset:TDH39 and EAR3A		OAE probe, RadioEarIP30 insert earphoneTitan used different accessories but Novus accessories perform same functions.

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Image /page/7/Picture/1 description: The image shows the logo for Grason-Stadler, also known as GSI. The logo features a stylized sound wave graphic in light blue, followed by the letters "gsi" in bold, black font. Below "gsi" is the text "Grason-Stadler" in a smaller, lighter font, indicating the full name of the company or brand.

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Image /page/8/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in blue, followed by the letters "gsi" in bold, black font. Below the letters, the words "Grason-Stadler" are written in a smaller, sans-serif font.

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Image /page/9/Picture/1 description: The image shows the logo for Grason-Stadler, also known as GSI. The logo features a stylized sound wave graphic in light blue on the left. To the right of the sound wave is the text "gsi" in bold, black font, with "Grason-Stadler" in a smaller font size underneath.

Summary of Non-Clinical Testing

Design verification and validation were performed according to current standards for OAE and ABR to assure the device meets its performance specifications. EMC and Safety was performed in compliance with recognized standards IEC 60601-1 series, Medical Electrical Equipment – General requirements for basic safety and essential performance. The product meets the requirements from the international standard for OAE measurements IEC 60645 series. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software for this device was considered as a "moderate" level of concern since a malfunction of, or a latent design flaw in, the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. The OAE and ABRIS measurements were divided into 3 phases. Phase included when optimization occurred and involved feedback to the operator so that they could adjust such as probe fit, electrode impedance, ambient electrical and acoustic noise etc. Once the pre-test conditions were optimized, phase 2 of data collection proceeded as rapid as possible to allow the maximum quantity of good quality data to be collected in the shortest possible time. Phase 3 proceeded into the data assessment and decision stage and this ran concurrently with Phase 2 once the predetermined minimum amount of data had been collected. Phase 3 then went into the algorithm descriptions for each TEOAE, DPOAE and ABRIS measurements modes. The detailed information about the validation and verification of PASS/REFER algorithms for the OAE and ABR modules is provided in the GSI Novus Manual, e.g., PASS/REFER Criteria, Sensitivity and Specificity etc. No clinical tests were performed, but based on the fulfillment of the international standards for OAE and ABR we believe the device is safe and effective. The auditory impedance testing characteristics and safety systems were compared and found to be comparable.

Summary of Clinical Testing

Not applicable. Not required to establish substantial equivalence.

Conclusion

We have compared the intended use and performance characteristics with the predicate devices. The Novus was tested according to current standards and the differences found between the devices were related to functionality, not in relation to safety and efficiency. The Novus conforms to the current standards. After analyzing bench testing, safety, EMC, and software validation (with risk analysis) testing we conclude that the Novus is found to be substantially equivalent to the predicate devices in technological characteristics and indications for use.

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.