The Scout Sport Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE Input/Output (I/O) tests.

Scout Sport is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function.

The device can be used for patients of all ages, from infants through adults, to include geriatic patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

Device Description

The Scout Sport Otoacoustic Emissions Measurement System performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. Using a combination of hardware and software, the Scout Sport system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the inner ear as a result of normal hearing process. The stimuli are presented via miniature receivers and the sounds in the external ear canal are recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. For transient evoked otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes are calculated and presented to the user. For distortion product otoacoustic emissions (DPOAEs), the DP and noise floor amplitudes are calculated and presented to the user. A pass or refer recommendation is assigned at the end of the test automatically based on predefined test protocols and measured OAE test parameters.

DPOAE I/O is a software option. The standard DPOAE test measures otoacoustic response to a series of frequencypairs of tones, varying the frequency while keeping the level or intensity of the stimulus tones at a constant level. The DPOAE I/O software option enables the Scout Sport device user to perform DPOAE testing at different stimulus intensities in order to obtain the DPOAE Input / Output (I/O) function for user defined test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level vs. DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE response.

The functionality of the Scout Sport system has been enhanced by addition of the following Scout software program modules: the Patient and Test Information database (P&TI), the BLReports application, and additional peripheral software utilities.

The Patient and Test Information database (P&TI) is used to store, display, and manage patient and test information records. The database stores the following:

Patient demographic information such as Patient Name, . Patient ID, Doctor Information, and comments; and,
Test demographic information such as ID. Test Dates. . and Test Results

The standalone BLReports application provides customizable reporting for Scout. The Scout application must invoke BLReports directly, passing the data necessary to create and use report templates. The report templates are made up of template components that can be added, modified or removed by the user.

The additional peripheral software utilities consist of the Feedback utility and the database Repair utility. The Feedback utility enables users to create an archive containing recent logs, databases, registry data and system information to be copied on a CD and provide to Natus Technical Support to assist in troubleshooting. The database Repair utility enables the repair and compaction of databases.

AI/ML Overview

The provided text describes the "Scout Sport Otoacoustic Emissions Measurement System" but does not contain a specific section detailing acceptance criteria or a dedicated study explicitly proving the device meets said criteria with quantitative performance metrics. The document focuses on demonstrating substantial equivalence to predicate devices.

However, based on the information provided, we can infer some aspects related to validation and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative format (e.g., minimum sensitivity, specificity). Instead, it relies on demonstrating that the device "meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices."

Therefore, a table of explicit acceptance criteria with reported numerical performance values cannot be constructed from the provided text. The performance is broadly described as the device accurately performing TEOAE, DPOAE, and DPOAE I/O tests to assess cochlear function, similar to its predicates.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Design verification and validation were performed to assure that the Scout Sport Otoacoustic Emissions Measurement System meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices."

It does not provide specific details on the sample size used for validation testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). This information is not typically included in a 510(k) summary for devices demonstrating substantial equivalence through functional and performance similarities to predicates rather than novel clinical performance claims.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of experts to establish a "ground truth" for a specific test set. The validation appears to be focused on meeting technical specifications and functional equivalence to predicate devices, rather than a clinical study requiring expert-derived ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a clinical test set requiring expert adjudication to establish ground truth.

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 device is an Otoacoustic Emissions Measurement System, which assesses cochlear function directly. It's not an AI-powered diagnostic tool requiring human reader interpretation or offering "AI assistance" in the typical sense. Therefore, an MRMC study and effect size in human reader improvement are not relevant to this device.

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

The device inherently operates in a "standalone" manner in terms of its core measurement function. It delivers acoustic signals and measures emissions independently. The "pass or refer recommendation is assigned at the end of the test automatically based on predefined test protocols and measured OAE test parameters." This implies an algorithm-only decision for the "pass/refer" outcome. However, it's not described as a "standalone algorithm performance study" in the context of an AI-based diagnostic tool. The device assesses cochlear function and then provides a recommendation based on its measurements.

7. The Type of Ground Truth Used:

The ground truth used for validation is implicitly based on the established performance and expected physiological responses of similar predicate devices, and the device's ability to accurately measure and report these responses according to its specifications. There is no mention of external "ground truth" such as pathology, clinical outcomes, or expert consensus in the traditional sense of a diagnostic imaging study. The "ground truth" is the accurate capture of otoacoustic emissions and appropriate application of pre-defined protocols for pass/refer recommendations.

8. The Sample Size for the Training Set:

Not applicable. This device is not described as utilizing a machine learning or AI model that requires a "training set" in the context of deep learning or statistical pattern recognition. Its operation is based on established audiology principles and signal processing.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for a machine learning model.

Summary

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K121512-

JUL 26 2012

510(k) SUMMARY

Manufacturer's Name:	Natus Medical IncorporatedOne Bio-logic PlazaMundelein, IL 60060
Corresponding Official:	Don WilliamsVice President and General ManagerNatus Medical IncorporatedOne Bio-logic PlazaMundelein, IL 60060
Telephone Number:	800.323.8326 ext. 5424
Fax Number:	847.949.8615
Summary Date:	May 18, 2012
Trade Name:	Scout Sport Otoacoustic Emissions Measurement System
Common or Usual Name:	Audiometer
Classification Nameand Number:	Audiometer 21 CFR 874.1050, Product Code: EWO
Predicate Devices:	K964132 Bio-logic Scout and Scout Sport OtoacousticEmissions (OAE) Test Instruments with TEOAE and DPOAESoftware, incorporating the modifications of AutomatedInput / Output Software Functions
	K112247 ABaer with ABaer I/O Function
Device Description:	The Scout Sport Otoacoustic Emissions MeasurementSystem delivers controlled acoustic signals in the ear canaland measures the resulting evoked otoacoustic emissions(OAEs) that are generated by the outer hair cells of the innerear. The Scout Sport device performs transient evokedotoacoustic emissions (TEOAE), distortion productotoacoustic emissions (DPOAE), and DPOAE Input/Output(I/O) tests.
Intended Use:	Scout Sport is indicated for use by trained health careprofessionals (audiologists, physicians) and personnel(nurses, technicians) who are trained to operate the deviceunder their supervision to perform TEOAE, DPOAE, andDPOAE I/O functions to assess cochlear function.

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The device can be used for patients of all ages, from infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

The functionality of the Scout Sport system has been enhanced by addition of the following Scout software program modules: the Patient and Test Information database

Technological Characteristics:

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(P&TI), the BLReports application, and additional peripheral software utilities.

The Patient and Test Information database (P&TI) is used to store, display, and manage patient and test information records. The database stores the following:

Patient demographic information such as Patient Name, . Patient ID, Doctor Information, and comments; and,
Test demographic information such as ID. Test Dates. . and Test Results

Nonclinical Tests:

Design verification and validation were performed to assure that the Scout Sport Otoacoustic Emissions Measurement System meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices.

The verification and validation summary report and risk analysis documentation provided in this 510(k) support the conclusion that the Scout Sport Otoacoustic Emissions Measurement System is safe and effective.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular pattern. The seal is rendered in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 26 2012

Natus Medical Incorporated c/o Don Williams Vice President and General Manager One Bio-logic Plaza Mundelein, IL 60060

Re: K121512

Trade/Device Name: Scout® Sport Otoacoustic Emissions Measurement System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: May 18, 2012 Received: May 21, 2012

Dear Mr. Williams:

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 (reporting of medical

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Page 2 - Don Williams

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 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/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 Small Manufacturers, International and Consumer Assistance 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 yours,

Malvina B. Eydelman, M.D.

Malvina B. Eydelman, M 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

K121512 510(k) Number (if known):

Device Name: Scout Sport Otoacoustic Emissions Measurement System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

of Device Evaluation (ODE) Concurrence of CDRH, Office

Ch
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number

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.