The SmartScreener-Plus2 device is indicated for use in the recording and automated analysis of human physiological data (auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearingrelated disorders. The device is especially indicated for use in the screening of infants to determine hearing loss.

Sites appropriate for use include the well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, outpatient clinic, audiologist's office, or doctor's office. The device is simple to operate. It does not require special technical skills or interpretation of results by the device operator. Basic training with the device is sufficient to learn how to operate it.

The SmartScreener-Plus2 device can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults.

The possible anatomical sites of contact are the patient's ear, ear canal, and/or external skin surrounding the ear (with the contact object being a sound delivery eartip, headphone cushion, or an acoustic ear coupler such as a circumaural ear cup, intra-aural ear bud, or supra-aural ear patch), the patient's head (with the contact object being a bone vibrator), and the patient's head, nape of the neck and shoulder (with the contact object being electrodes that are capable of measuring biopotentials).

The SmartScreener-Plus2 device is for prescription use.

Device Description

The SmartScreener-Plus2 is a noninvasive device used to test for hearing and related neurological abnormalities. The device is especially indicated for use in the screening of infants to determine hearing loss.

The SmartScreener-Plus2 device records and detects auditory evoked potentials (AEPs) and otoacoustic emissions (OAEs) which are generated in response to a series of auditory stimuli delivered to the patient. AEPs are electrical signals produced by the patient's nourological activity and are picked up by electrodes attached to the patient's skin. The portion of the AEP that originates from the anatomical structures of the inner ear to the auditory brainstem is commonly called the Auditory Brainstem Response (ABR). Otoacoustic emissions are acoustic signals produced by the patient's inner ear and are picked up by a sensitive microphone located in an OAE probe. The SmartScreener-Plus2 device is capable of recording Transient Evoked OAEs (TEOAEs or TrOAEs), and Distortion Product OAEs (DPOAEs)

The SmartScreener-Plus2 uses advanced signal processing technology to separate AEPs and OAEs from background noise and other physiological activity. The device uses proven statistical algorithms to automatically determine if there is an AEP or OAE response present to the auditory stimuli delivered to the patient. A user, with device administrator approved password security clearance, is able to set the output level of the stimulus. AEP stimulus levels between 30 to 40 dB nHL, and TEOAE stimulus level of 85 dB SPL, and DPOAE stimulus levels of 65 and 55 dB SPL are commonly used for newborn hearing screening applications.

The SmartScreen-Plus2 device is simple to operate. It does not require any special technical skills or interpretation of results. Basic training is sufficient to learn how to use the device.

AI/ML Overview

Here's an analysis of the provided text regarding the SmartScreener-Plus2 device, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device submitted to the FDA in 2009. These summaries are designed to establish substantial equivalence to predicate devices, not necessarily to detail comprehensive clinical trial results in the same way a new drug application or a more recent medical device submission might. Therefore, some of the requested information, particularly regarding detailed study methodologies, sample sizes, and expert qualifications for ground truth establishment, is not explicitly present in this type of document.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or other performance metrics. Instead, "acceptance" is framed around demonstrating substantial equivalence to existing, legally marketed predicate devices. The core acceptance criterion for this 510(k) submission is that the SmartScreener-Plus2 device is as safe and effective as its predicate devices for its intended use.

The "reported device performance" is largely presented through a comparative table with predicate devices, highlighting similarities in design, materials, indications for use, and compliance with safety standards.

Acceptance Criterion (Implied)	Reported Device Performance
Safety	- Meets Electrical Safety Standards: IEC60601-1, UL2601-1, CSA-C22.2 No. 601.1, AAMI.ES1, EN60601-1, EN60601-1-2, EN60601-2-40, EN55011, EN61000-3-2, EN61000-3-3. - Biocompatible (materials are completely biocompatible). - No chemicals involved. - No mechanical parts in contact with patient.
Effectiveness (Functional Equivalence)	- Records and detects Auditory Evoked Potentials (AEPs) and Otoacoustic Emissions (OAEs) for diagnosis of auditory/hearing-related disorders and infant hearing screening. - Uses advanced signal processing and proven statistical algorithms for automated response determination. - Operates simply, without special technical skills or result interpretation. - Stimulus levels (AEP: 30-40 dB nHL, TEOAE: 85 dB SPL, DPOAE: 65 and 55 dB SPL) are commonly used for newborn screening.
Substantial Equivalence to Predicate Devices	- Target Population: Same (all ages). - Where Used: Same (clinical setting). - Anatomical Sites: Same (scalp, ear, and other skin sites). - Sterility: Same (none required). - Biocompatibility: Same (completely biocompatible). - Design: Same (main hardware unit connected to patient cables/transducers and portable computer with software). - Components/Materials: Same (main hardware unit, transducers, acoustic couplers, electrodes, cables, computer, printer, cart). - Human Factors: Same (simple, easy-to-follow instructions and software user interface). - Standards: Same (none known explicitly for performance, but electrical/thermal safety standards met). - Energy Used/Delivered: Same (stimulation of auditory system). - Chemical Safety: Same (no chemicals). - Mechanical Safety: Same (no mechanical parts in contact with patient). - Thermal Safety: Same (device not thermal in nature).

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states: "The SmartScreener-Plus2 device specifications were verified and validated."
- However, no specific details about a clinical test set sample size, data provenance, or whether the study was retrospective or prospective are provided in this 510(k) summary. This type of detail is often summarized or cross-referenced to internal validation reports, which are not publicly disclosed in the 510(k) summary.
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):
- Not specified. The document focuses on the device's technical specifications and substantial equivalence, not a detailed clinical outcomes study involving expert interpretation for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Since no explicit clinical test set with human ground truth establishment is detailed, no adjudication method is mentioned.
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, an MRMC comparative effectiveness study was not done or described. This device is an automated screening tool, not an AI-assisted interpretation tool for human readers in the traditional sense. It automates the analysis of physiological data (AEPs and OAEs) directly, with a "pass/refer" outcome, meaning it eliminates the need for complex interpretation by the device operator. The text explicitly states: "It does not require any special technical skills or interpretation of results."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device is designed for standalone automated analysis. The "Performance Testing" section states, "The SmartScreener-Plus2 device specifications were verified and validated." While specifics are absent, this verification and validation would inherently test the algorithm's performance in automatically determining the presence or absence of AEP or OAE responses. The device is marketed as not requiring "interpretation of results by the device operator," indicating its standalone analytical function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document mentions the device uses "proven statistical algorithms to automatically determine if there is an AEP or OAE response present." For this type of device, ground truth would typically be established by:
  - Physiological standards/biomarkers: The presence or absence of a physiological AEP or OAE response based on established audiology and neurophysiology principles, often confirmed by expert audiologists or neurophysiologists using gold-standard diagnostic equipment.
  - Clinical diagnosis/outcomes: Correlation of screening results with definitive diagnostic tests (e.g., full audiometry, follow-up examinations) to determine actual hearing status.
- The specific method for establishing ground truth for validation is not detailed in this summary.
The sample size for the training set:
- Not specified. This pertains to the internal development and calibration of the "advanced signal processing technology" and "proven statistical algorithms." The 510(k) summary does not include details on the training set for these algorithms.
How the ground truth for the training set was established:
- Not specified. Similar to the training set size, the method for establishing ground truth for the training of the device's algorithms is not disclosed in this regulatory summary. It would typically involve large datasets of AEP and OAE recordings from individuals with known hearing status, often categorized by expert review or correlation with comprehensive diagnostic audiometric evaluations.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Intelligent Hearing Systems. The logo has a graphic to the left of the words "Intelligent Hearing" stacked on top of "Systems". The graphic is a square with rounded corners and a series of concentric arcs inside. The letters in "Systems" are each in their own square.

0(k) Summarv

JUL - 7 2009

Submitter:	Intelligent Hearing Systems6860 SW 81st StreetMiami, FL 33143
Telephone:FAX:Contact Person:	(305) 668-6102(305) 668-6103Edward Miskiel, Ph.D.
Date Summary Prepared:	June 18, 2009
Trade Name:	SmartScreener-Plus2
Common Name(s):	Auditory Evoked Potential Device, Otoacoustic Emissions Device,Automated Hearing Screener.
Classification Name:	Auditory Evoked Response Stimulator (per CFR.882.1900)& Audiometer (per CFR 874.1050)
Predicate Device(s):	Bio-logic ABaer Cub with integrated OAE and ABR functions510(k) #K021801Intelligent Hearing Systems SmartEP-ASSR 510(k) #K031051

Description of the Device:

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between 30 to 40 dB nHL, and TEOAE stimulus level of 85 dB SPL, and DPOAE stimulus levels of 65 and 55 dB SPL are commonly used for newborn hearing screening applications.

The SmartScreen-Plus2 device is simple to operate. It does not require any special technical skills or interpretation of results. Basic training is sufficient to learn how to use the device.

Indications for Use:

. The SmartScreener-Plus2 device is indicated for use in the recording and automated analysis of human physiological data necessary (auditory brainstem responses and/or otoacoustic emissions) for the diagnosis of auditory and hearing-related disorders. The device is especially indicated for use in the screening of infants to determine hearing loss.

The SmartScreener-Plus2 device is for prescription use.

Comparison with Predicate Device:

Comparisons of technological characteristics of the SmartScreener-Plus2 with the predicate devices (Bio-logic ABaer Cub with integrated OAE and ABR functions and the Intelligent Hearing Systems SmartEP-ASSR) are given in the table below:

Parameter for Comparison	Predicate DeviceBio-logic ABaer Cub with integratedOAE and ABR functions (K021801)	Predicate DeviceIHS SmartEP-ASSR(K031051)	Similarity orDifference toPredicate Devices
Target Population	Patients of all ages.	Same.	Same.
Where Used	Clinical setting.	Same.	Same.
Anatomical Sites	Scalp, ear and other skin sites.	Same.	Same.
Sterility	None required.	Same.	Same.
Biocompatibility	Completely biocompatible.	Same.	Same.

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Design	Main hardware unit (housingcircuitry, supplies, and equipment)connected to (1) patient cables andtransducers and (2) a portablecomputer (with installed testingsoftware).	Same.	Same.
Components/Materials	Main hardware unit, transducers,acoustic couplers, electrodes, cables,computer, printer and cart.	Same.	Same.
Human Factors	Simple, easy-to-follow instructionsand software user interface.	Same.	Same.
Standards.	None known.	Same.	Same.
Energy Used and/orDelivered	Stimulation of auditory system.	Same.	Same.
Chemical Safety	No chemicals are involved in the useof this device.	Same.	Same.
Mechanical Safety	No mechanical parts in contact withpatient.	Same.	Same.
Electrical Safety	Meets IEC60601-1, UL2601-1,CSA-C22.2 No. 601.1, AAMI.ES1,and CE Mark.	Meets EN60601-1,EN60601-1-2,EN60601-2-40,EN55011,EN61000-3-2,EN61000-3-3, andCE Mark.	Same as SmartEP-ASSR (K031051).
Thermal Safety	Device is not thermal in nature.	Same.	Same.

Substantial Equivalence:

Based on the information presented here, the SmartScreener-Plus2 device is substantially equivalent to the Bio-logic ABaer Cub with Integrated OAE and ABR and the Intelligent Hearing Systems SmartEP-ASSR devices.

Performance Testing:

This submission includes a comparison table of specifications for both the SmartScreener-Plus2 device and the predicate devices. The SmartScreener-Plus2 device specifications were verified and validated.

Conclusions:

Based on the information presented in this submission, the SmartScreener-Plus2 device is as safe and effective as the identified predicate devices, the Bio-logic ABaer Cub with integrated OAE and ABR and the Intelligent Hearing Systems SmartEP-ASSR.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and iconic, representing the HHS's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intelligent Hearing Systems % Edward Miskiel, Ph.D. President & CEO 6860 SW 81 51 Street Miami, Florida 33143

JUL - 7 2009

Re: K090579

Trade/Device Name: SmartScreener-Plus2 Regulation Number: 21 CFR 882.1900 Regulation Name: Auditory Evoked Response Stimulator Regulatory Class: Class II Product Code: GWJ, EWO Dated: June 18, 2009 Received: June 24, 2009

Dear Dr. Miskiel:

We have reviewed vour 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 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 (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

MAJ. R. E. H. M.D.

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

Enclosure

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Indications for Use

510(k) Number: K090579

Device Name: SmartScreener-Plus2

Indications For Use:

The SmartScreener-Plus2 device is for prescription use.

510(k) Number

Prescription Use _______X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

Page 1 of 1K090579

Regulation Number and Section

§ 882.1900 Evoked response auditory stimulator.

(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).