The intended use of the current Scout Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. The intended use of this new software feature is essentially the same as that of the predicate device. It provides for an additional test methodology which measures DPOAE threshold instead of the more-routine DPOAE amplitude test. The threshold test (also called the Input/Output (1/0) function) involves varying the stimulus intensity levels while keeping the frequencies constant. Both test methods can be effectively used to differentiate normal and hearing- impaired subjects, but the amplitude test is usually preferred because it usually requires a shorter testing time. However, in cases where the amplitude test results in a DP-gram with a low DP response (close to the noise floor) at specific frequencies, the I/O function test can be used to determine if there is an improved response at other stimulus frequencies. Therefore, the I/O function test offers the potential to improve the identification of patients with normal hearing.

Device Description

Addition to the Scout Otoacoustic Emissions (OAE) Test Instrument. Modification and Software Feature. The system still uses the Etymotic ER-10C probe.

AI/ML Overview

The provided text describes a modification to the Bio-logic Scout Otoacoustic Emissions (OAE) Test Instrument, specifically the addition of a new software feature for measuring DPOAE threshold (Input/Output or I/O function). The document focuses on regulatory compliance and demonstrating that the new feature does not negatively impact safety or effectiveness. As such, it does not contain the typical performance metrics (sensitivity, specificity, AUC, etc.) and study design details usually found for AI/ML device evaluations.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device presents no new safety issues compared to predicate.	Verified. No changes to hardware or software controlling hardware. Only changes are to test sequence generation, which does not affect safety. No direct electrical connection to the patient.
Effectiveness (General): Performs in accordance with specifications.	Verified. System was validated in accordance with IEEE Standards for Software Engineering and Bio-logic's internal development policies. Found to perform in accordance with specifications.
Effectiveness (Intended Use): Effectively differentiate normal and hearing-impaired subjects; potential to improve identification of patients with normal hearing.	This claim is made for both the original DPOAE amplitude test and the new I/O function. The I/O function offers additional information when the amplitude test results in a low DP response, potentially improving identification of normal hearing. Specific performance metrics (e.g., sensitivity, specificity, accuracy) for this new feature are not provided.
Performance (Time):	The time to perform a DPOAE I/O (threshold) test is somewhat longer than the DPOAE amplitude test. No specific duration or acceptable range is provided.

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

This information is not provided. The document describes software validation and verification, implying internal testing, but no details on clinical test sets (e.g., number of patients, their demographics, country of origin) are given for the new I/O feature's performance effectiveness.

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

This information is not provided. Given that the validation focuses on software functionality rather than a clinical performance study with human interpretation, external experts for ground truth establishment are not mentioned for the new feature. The "ground truth" here seems to be the system's ability to correctly generate the specified test sequences and display results.

4. Adjudication Method for the Test Set

This information is not provided. There is no mention of a clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is not an AI/ML algorithm that assists human readers in interpretation. It's a re-sequencing of a medical test.

6. Standalone Performance Study

A standalone performance study in the context of an AI/ML algorithm (i.e., algorithm only without human-in-the-loop performance) was not done. This device is a test instrument. The "standalone" performance here refers to the software performing its intended function (generating test sequences and displaying data), which was verified through internal validation.

7. Type of Ground Truth Used

For the software validation, the "ground truth" seems to be:

Adherence to IEEE Standards for Software Engineering.
Adherence to Bio-logic internal software development policies and procedures.
Performance in accordance with specifications (implicitly referring to design requirements for test sequence generation and data presentation).

There is no mention of a ground truth established by clinical outcomes, pathology, or expert consensus regarding the diagnostic performance of the new DPOAE threshold feature itself in differentiating normal from hearing-impaired subjects.

8. Sample Size for the Training Set

This information is not applicable / not provided. This is not an AI/ML device that requires a training set. The validation described is for software engineering and functionality.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable / not provided. This is not an AI/ML device with a training set.

Summary

{0}------------------------------------------------

K964432

MAY 1 3 1997

Biologic One Bio-logic Plaza Mundelein, Illinois 60060-3700 1-800-323-8326 Fax: 847-949-8615

SUMMARY AND CERTIFICATION SECTION 2:

510 (K) SUMMARY

SAFETY AND EFFECTIVENESS SUMMARY

Safety and effectiveness information concerning this modification to the Scout OAE device is summarized below.

Because this is not a CLASS III device, the special certification defined for this section is not required.

PREPARED BY:	Bio-logic Systems Corp
	One Bio-logic Plaza
	Mundelein, IL 60060

TELEPHONE :

(847) -949-5200

CONTACT PERSON :

Norman E. Brunner

DATE ON WHICH THE SUMMARY October 7, 1996 WAS PREPARED:

NAME OF DEVICE:

Addition to the Scout Otoacoustic Emissions (OAE) Test Instrument.

Modification and Software Feature

COMMON NAME : Otoacoustic Emissions Test Instrument

CLASSIFICATION NAME: Audiometer (per CFR 874.1050).

PREDICATE DEVICE: Bio-logic Scout OAE Instrument (K944735)

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REVISED STATEMENT OF INTENDED USE FOR 510(k) #K964132

ي پريز جي ته ا

INTENDED USE: The intended use of the current Scout Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. The intended use of this new software feature is essentially the same as that of the predicate device. It provides for an additional test methodology which measures DPOAE threshold instead of the more-routine DPOAE amplitude test. The threshold test (also called the Input/Output (1/0) function) involves varying the stimulus intensity levels while keeping the frequencies constant. Both test methods can be effectively used to differentiate normal and hearing- impaired subjects, but the amplitude test is usually preferred because it usually requires a shorter testing time. However, in cases where the amplitude test results in a DP-gram with a low DP response (close to the noise floor) at specific frequencies, the I/O function test can be used to determine if there is an improved response at other stimulus frequencies. Therefore, the I/O function test offers the potential to improve the identification of patients with normal hearing.

DPOAE threshold is the lowest stimulus intensity level which produces a DPOAE response amplitude that is distinguishable from the level of system distortion and from the noise floor. DPOAE threshold is expressed in much of the published literature as the lowest intensity of the F2 stimulus that generates a clear DPOAE response. DPOAE threshold does not equate to and should not be confused with audiometric or auditory threshold. Whereas auditory threshold measures assess the integrity of the entire auditory system from outer ear to cortex, DPOAE threshold measures are limited to assessment of outer hair cell function in the cochlea only.

(This statement replaces the text on pages 8 and 11 of the original 510(k) submission. )

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Modification and Feature Addition to Bio-logic Scout Otoacoustic Emissions (OAE) Test Instrument

PATIENT POPULATION: Adults, children and infants.

SAFETY AND EFFECTIVENESS:

No changes have been made to the hardware design of the Scout product Therefore, the Scout product which incorporates this new line. software feature does not present any safety issues which have not already been addressed in the predicate Scout 510(k) notifications. Also, the Scout software modules which are used to control the hardware have not been changed. This new feature only changes the sequence in which tones of varying intensity and frequency are Instead of keeping stimulus qenerated when conducting a test. intensity constant and varying frequency, the frequencies are kept constant and the stimulus intensity is varied. Therefore, this new feature does not affect the safety of the Scout product.

To establish the safety and effectiveness of the software which Input/Output feature, the system was validated in accordance with the IEEE Standards for Software Engineering, as well as Bio-logic internal software development policies and procedures modeled after the IEEE Standards. Changes to the standard Scout PC computer program necessary to generate new test sequences and the presentation of this data were all developed and tested as specified in these The system, for which this application is submitted, was procedures. verified and validated; it was found to perform in accordance with specifications.

Page 3

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Modification and Feature Addition to Bio-logic Scout Modiffication Emissions (OAE) Test Instrument

The following comparison is provided as a summary of technological
characteristics relative to the predicate device society characteristics that the addition of this new Input/Output software is
demonstrates that the addition of this new Input/Output software affect product safety and effectiveness.

Parameter for comparison.	Similarity or Difference.
Intended Use	No differences.
Population	No differences.
Hardware Configuration	No differences.
Computer Control Software	Only differences are changes to Scoutsoftware required to support the newInput/Output feature addition. Thereare no differences in software testalgorithms.
Ear Probe System	No differences. The system stilluses the Etymotic ER-10C probe.
Performance	The time to perform a DPOAE I/O(threshold) test is somewhat longerthan that required for the moreroutine DPOAE amplitude test.However, the I/O test can provideadditional information which theroutine test cannot easily provide,which can, in some cases, beclinically useful.
Safety Characteristics	No difference. There is no directelectrical connection to the patientin any Bio-logic OAE system.

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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.