The Bio-logic Ear Muffins® is a disposable earphone device intended to be used as an accessory to the Bio-logic ABaer / Navigator Pro auditory evoked response screening and diagnostic systems, and the Natus Medical Inc. ALGO series auditory evoked response screening systems. The Ear Muffins® device performs as the means for delivering the auditory stimulus from the auditory stimulator to the ear of the patient under test.

The Bio-logic Ear Muffins® device is especially indicated for use in the auditory evoked response screening of newborn infants, because the Ear Muffins® can be placed to cover the entire ear of the infant, so nothing has to be placed into the ear canal.

Device Description

The Bio-logic Ear Muffins consist of a pair of single-use, disposable foam & plastic donutshaped devices for delivering sound to the human ear. The Ear Muffin is specifically designed in size and shape to be used with infants. The Ear Muffin is one of the alternative sound delivery devices offered as accessory options to the ABaer and Navigator Pro product lines. The ABaer/Navigator Pro has received FDA Marketing Clearance via 510(k) #K994149. The Ear Muffins can also be used as a stand-alone device with the Natus Medical ALGO series of Newborn Hearing Screening systems, as demonstrated in the test results within this 510(k) notification.

Electrical safety is not an issue with the Ear Muffins, because the Ear Muffin is not electrical in nature, it is simply a different tubing system for sound delivery to the ear. The Ear Muffins connect to the output of Auditory Stimulator device (e.g., Natus ALGO), and provide an acoustic pathway to direct the auditory stimulus to the ear of the infant. The Muffins are applied to the baby's head to cover the ears, similar to the way a large set of headphones might cover the ears of an adult.

The Ear Muffin only makes very brief contact with the skin, and does not contact in vivo body tissues or fluids. The material used for the Ear Muffins has been found to be safe for this use by its manufacturer through appropriate biocompatibility testing.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Bio-logic Ear Muffins, which are disposable earphones for auditory stimulus delivery, primarily for newborn hearing screening. The study described focuses on demonstrating substantial equivalence to a predicate device, rather than establishing new performance criteria for a novel device.

Here's an analysis of the "acceptance criteria" and "study" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter for Comparison	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Bio-logic Ear Muffins®)	Meets Acceptance Criteria?
Performance	Average stimulus strength measured in ear canal with predicate device (Natus Ear Coupler)	Average stimulus strength measured in ear canal is 79.28 dB SPL with standard deviation of 1.34 dB SPL.	Yes
Equivalence Gap	Within 1 dB SPL difference in average sound levels compared to the predicate device.	Average of all sound levels measured with Ear Muffins was within 1 dB SPL of the average with Natus Ear Coupler.	Yes
Standard Deviation	Standard deviation for sound levels with predicate device (Natus Ear Coupler) ~1.4 dB SPL.	Standard deviation for sound levels was approximately 1.4 dB SPL.	Yes

Note: The acceptance criteria here are derived from the performance of the legally marketed predicate device (Natus Medical Inc. Ear Coupler) as the goal of the study was to demonstrate substantial equivalence, not to set new independent performance benchmarks.

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

Sample Size: The document mentions "a large number of test subjects"
Data Provenance: Not explicitly stated, but clinical studies for 510(k) submissions in the US are typically prospective or retrospective studies conducted in the US. No specific country of origin is mentioned, and it is not explicitly stated whether the data was retrospective or prospective. However, given it's a 510(k) submission, the data would generally be expected to be collected recently to support the claim.

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

This information is not applicable to this study. The study focuses on objective, physical sound level measurements (dB SPL) within the ear canal, not on diagnostic interpretations or judgments that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to this study, as the ground truth is based on objective physical measurements rather than expert consensus requiring adjudication.

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

No. This was not an MRMC comparative effectiveness study. The device is a passive accessory (ear muff) for delivering auditory stimuli, not a diagnostic algorithm that would be used by human readers for interpretation. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable in the conventional sense of an "algorithm only" study. The device itself is a passive, non-electrical component. Its performance was measured in conjunction with an auditory stimulator device (Natus ALGO-2), but the "performance" here refers to the physical sound energy it delivers, not an algorithm's output. The measurement of sound levels is a direct physical test, not an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" (or reference standard) used was objective physical sound level measurements (dB SPL) obtained directly within the ear canal of test subjects. The performance of the Bio-logic Ear Muffins was then compared against the same type of measurements obtained with the predicate device.

8. Sample Size for the Training Set

This information is not applicable. This study does not involve an AI algorithm that requires a "training set." It is a physical performance comparison study.

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

This information is not applicable, as there is no training set for an AI algorithm in this study.

Summary

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OCT 1 5 2001

Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "KO12384". The characters are written in a cursive style with a slight slant.

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

SECTION 10 BIO-LOGIC EAR MUFFINS ® 510(k)

PREMARKET NOTIFICATION 510(k) SUMMARY

PREPARED BY:

Bio-logic Systems Corp One Bio-logic Plaza Mundelein, IL 60060

TELEPHONE: FAX: Email:

(847)-949-5200 ext. 224 (847)-949-8615 normb@blsc.com

Norman E. Brunner CONTACT PERSON:

DATE ON WHICH THE SUMMARY WAS PREPARED: July 20, 2001

NAME OF DEVICE: Bio-logic Ear Muffins®

Earphones for Evoked Response auditory stimulus delivery. COMMON NAME:

CLASSIFICATION NAME: Accessory to primary device, classification: Stimulator, Auditory, Evoked Response, (per 21 CFR section 882.1900).

PREDICATE DEVICE: Natus Medical Inc. Ear Coupler Earphones, part of ALGO Disposable Kit used with ALGO-2 Newborn Hearing Screener, 510(k) #K936039.

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DESCRIPTION OF THE DEVICE:

INTENDED USE OF THE DEVICE:

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COMPARISON SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

PARAMETER FORCOMPARISON	Bio-logic Systems Corp.Ear Muffins®	Similarity ordifference to PredicateDevice
Indications for Use	Auditory Evoked Responsescreening for infants.	Same.
Target Population	Newborn & very young infants.	Same.
Design	Lightweight foam & plastic donut-shape covered earphones withplastic tubing connecting tostimulator	Slight differences insize, shape andthickness of materials.
Materials	Disposable foam & plastic.	Very similar.
Performance	Average stimulus strength measuredin ear canal is 79.28 dB SPL withstandard deviation of 1.34 dB SPL.	Same to within less than1 dB SPL.
Sterility	Not supplied sterile.	Same.
Biocompatibility	All materials successfully passedbiocompatibility testing.	Same.
Mechanical Safety	No mechanical parts.	Same.
Chemical Safety	No chemicals involved in the use ofthis device.	Same.
Anatomical Sites	Device is placed covering the ear ofnewborn infants.	Same.
Human Factors	Simple, easy-to-follow instructionsare provided.	Same.
Energy Used and/orDelivered	Device is passive and consumes noenergy. Only Auditory energy isdelivered as noted above.	Same.
Standards Met	Associated with stimulation device.	Same.
Electrical Safety	Device not electrical in nature.	Same.
Thermal Safety	Device not thermal in nature.	Same

DISCUSSION AND ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA:

Non-clinical testing was performed to demonstrate the substantial equivalence of the Bio-logic Ear Muffins® to the Natus Medical Inc. Ear Couplers. This performance testing consisted of measuring the sound level within the ear canal of a large number of test subjects, using the Natus ALGO-2 device with (1) the Natus Ear Coupler and (2) the Bio-logic Ear Muffins®. The average of all sound levels measured with (1) was within 1 dB SPL of the average of all sound levels measured with (2). Standard deviation for the results of tests (1) and (2) were approximately 1.4 dB SPL in both cases. Therefore, it is concluded that the performance of the Bio-logic Ear Muffins® is very similar to that of the Natus Medical Inc. Ear Coupler, and it is therefore substantially equivalent to this predicate device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

OCT 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Norman E. Brunner Vice President of Research and Development Bio-Logic Systems Corporation One Bio-logic Plaza Mundelein, Illinois 60060

Re: K012384

Trade/Device Name: Bio-logic Ear Muffins Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC Dated: July 26, 2001 Received: July 27, 2001

Dear Mr. Brunner:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of 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). and Oosmeter For (110) that the device, subject to the general controls provisions of the Act. The I ou may, dicrore, marks 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 If your device to such 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 r toase be actived that I Dr bristian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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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Page 2 - Mr. Norman E. Brunner

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

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Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Not Assigned

K012384

........

Device Name: Bio-logic Ear Muffins®

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Su-WL

(Division Sim-Off) Division of General, Restorative and Neurological Devices

510(k) Number_140123 €4

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.5050 Biofeedback device.

(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.