The ALGO® 3 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.

Device Description

Like the predicate device, the ALGO 3 detects the auditory brainstem response (ABR) to a series of stimulus clicks ('clicks'), which screens the entire hearing pathway from the outer ear to the brainstem. The ABR is not affected by the status of the middle ear, and evaluation of middle ear status is not required prior to ABR detection. The ALGO 3 generates soft clicks at 35 dB nHL ('normal hearing level' scale) which are delivered to the infant's ears through an Acoustic Transducer Assembly cable (ATA) to disposable earphones (Flexicouplers™ Disposable Earphones); a 35 dB nHL stimulus will detect a 30 dB nHL hearing loss. Each click evokes a series of identifiable brain waves from the auditory brainstem area of the infant's brain. Sensors (Jelly Tab™ Sensors) applied to the infant's skin pick up the brain wave response and transmit the signals to the screener via the Patient Cable Attachment (PCA) and Preamplifier (Preamp) assemblies. The screener uses advanced signal processing technology to separate the ABR from background noise and from other brain activity. The ALGO 3 automatically compares the baby's ABR to a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology), and prints a "PASS" or "REFER" result. A "PASS" result is printed if the ALGO 3 can detect, with sufficient statistical confidence, that an ABR is present and consistent with its template. A "REFER" result is printed if the ALGO 3 cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template. A built-in printer prints the result on a self-adhesive label, which can be affixed directly to the infant's medical chart.

The ALGO 3 is also capable of screening using clicks at 40 dB nHL. Some newborn hearing programs (international programs, for example), and some programs prefer to set the screening threshold at 40 dB nHL rather than at 35. The incorporation of a 40 dB screening application in the ALGO 3 device makes the device more useful to more users.

The ALGO 3 device is easy enough for trained volunteers and other trained non-medical personnel to use. Interpretation of screening results is not required, as the screener automatically determines if the response is consistent with a template and automatically generates a "PASS" or "REFER" result, as previously discussed. In addition, training is minimal because of the easy-to-navigate graphical user interface, HELP topics in software, and a user tutorial in the ALGO 3 software.

Screening results can be tracked using the integrated ALGO DataBook® NHS Data Tracking System software. The DataBook utility retrieves and displays patient and screening data stored in ALGO 3 software. Data can be viewed on the ALGO 3's display; can be saved as an ASCII file on diskette for data management and reporting purposes; and can be exported to other databases for data management and reporting purposes.

There are no user-adjustable parameters, so that each screen is performed under exactly the same conditions. Click rate, click intensity, impedance threshold, and noise rejection thresholds are all pre-programmed into the device software, and users cannot change these screening parameters.

The ALGO 3 is composed of the following components, as is the Predicate Device:

Screening module, with laptop computer
Printer module, with label printer
Cable assemblies (ATA, PCA, Preamp)
Cart for transport and component storage
Screening and accessory supplies

Accessories available for use with the ALGO 3 include single-use, disposable FlexiCouplers Disposable Earphones, and single-use, disposable Jelly Tab Sensors.

AI/ML Overview

The provided text does not contain detailed information regarding specific acceptance criteria or a dedicated study proving the device meets said criteria with quantitative performance metrics. This document primarily focuses on the device's description, intended use, and substantial equivalence to a predicate device for 510(k) clearance.

However, based on the information provided, we can infer some aspects and highlight what is missing.

Here's an attempt to structure the answer based on your request, indicating where information is present and where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from functionality)	Reported Device Performance (Implied)
Accuracy: Ability to correctly identify "PASS" (hearing present) or "REFER" (hearing loss suspected) based on ABR response.	The ALGO 3 "automatically compares the baby's ABR to a template of ABRs derived from normal hearing infants... and prints a 'PASS' or 'REFER' result." "A 'PASS' result is printed if the ALGO 3 determines, with sufficient statistical confidence, that an ABR is present and consistent with its template. A 'REFER' result is printed if the ALGO 3 cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template."
Sensitivity for 30 dB nHL hearing loss: Detects hearing loss at this threshold.	"A 35 dB nHL stimulus will detect a 30 dB nHL hearing loss."
User proficiency: Ease of use by trained non-medical personnel.	"The ALGO 3 device is easy enough for trained volunteers and other trained non-medical personnel to use. Interpretation of screening results is not required... training is minimal because of the easy-to-navigate graphical user interface, HELP topics in software, and a user tutorial in the ALGO 3 software."
Screening time: Efficiency of the screening process.	"A typical screening process can be completed in 15 minutes or less."
Reproducibility/Consistency: Consistent results under the same conditions.	"There are no user-adjustable parameters, so that each screen is performed under exactly the same conditions. Click rate, click intensity, impedance threshold, and noise rejection thresholds are all pre-programmed into the device software, and users cannot change these screening parameters."

The document does not provide quantitative performance metrics such as sensitivity, specificity, positive predictive value, or negative predictive value from a specific study to directly validate these criteria. The emphasis is on similarity to the predicate device, the ALGO-2 Newborn Hearing Screener, which likely had its own performance data for establishing substantial equivalence.

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

This information is not explicitly stated in the provided text. The document describes the device's functionality and comparison to a predicate but does not detail a specific clinical trial or study undertaken for the ALGO 3's 510(k) submission that would involve a test set.

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

This information is not explicitly stated in the provided text. The device uses an "automated auditory brainstem response technology" and "compares the baby's ABR to a template of ABRs derived from normal hearing infants." It does not mention human experts establishing ground truth for individual test cases in the context of a validation study for the ALGO 3's performance itself. The "template of ABRs" would have been established previously, potentially using expert interpretation from a historical dataset.

4. Adjudication Method for the Test Set

This information is not explicitly stated in the provided text, as there is no described specific test set or clinical study for the ALGO 3 featuring human adjudication. The device itself performs an automated "PASS" or "REFER" determination.

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

A MRMC comparative effectiveness study was not described or indicated in the provided text. The ALGO 3 is designed to be automated, used by "trained volunteers and other trained non-medical personnel," with "interpretation of screening results is not required." Therefore, a study comparing human readers with and without AI assistance is not relevant to the described operational model of the device.

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

The device itself is a standalone algorithm in its core function. It "automatically determines if the response is consistent with a template and automatically generates a 'PASS' or 'REFER' result." The document implies that the device's performance, given its automation, is its standalone performance. However, no specific study detailing this standalone performance (e.g., sensitivity, specificity vs. a gold standard clinical diagnosis) is provided in this summary. The 510(k) submission relies on substantial equivalence to a predicate device, not necessarily a new standalone clinical trial for the ALGO 3 itself.

7. Type of Ground Truth Used

The ground truth for the device's operation is implicitly "ABRs derived from normal hearing infants." The device's algorithm compares the captured ABR to this established template. The ultimate ground truth relevant to "hearing loss" would be a clinical diagnosis of hearing loss, but the document describes the device comparing to a "template" of normal ABRs, which acts as the reference for its automated decision-making.

8. Sample Size for the Training Set

This information is not explicitly stated in the provided text. The "template of ABRs derived from normal hearing infants" would have been the equivalent of a training or reference set, but its size is not mentioned.

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

The text states the ALGO 3 "compares the baby's ABR to a template of ABRs derived from normal hearing infants." This implies that the template was established by taking ABR readings from a cohort of infants confirmed to have normal hearing. How this "normal hearing" was confirmed (e.g., through follow-up audiological assessments, other screening methods, or clinical consensus) and the methodology for creating the "template" (e.g., statistical averaging, machine learning model) is not detailed in this document.

Summary

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OCT 1 6 2001

Image /page/0/Picture/3 description: The image shows the word "natus" in a bold, sans-serif font. The letters are black against a white background. A small registered trademark symbol is located to the right of the letter "s".

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ K013137

Submitter: A.

Natus Medical, Inc. 1501 Industrial Road San Carlos, CA 94070

phone: (650) 802-0400 (650) 802-6621 fax:

Contact: Sheila Ramerman

Date Prepared: October 12, 2001

B. Device Names:

Classification name	Stimulator, Auditory Evoked Response
Common/usual name	Hearing Screener
Proprietary name	ALGO® 3 Newborn Hearing Screener

C. Predicate Device:
ALGO-2 Newborn Hearing Screener, KA36039

D. Device Description:

Natus Medical Inc. 1501 Industrial Road, San Carlos, CA94070-4111 650-802-0400 FAX 650-802-0401

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brain activity. The ALGO 3 automatically compares the baby's ABR to a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology), denved from normal learing analis (actornation a different is printed if the ALGO 3
AABR), and prints a "PASS" or "REFER" result. A "PASS" result is printed in the AADN), and prints a - 1785 - or - 100. mfidence, that an ABR is present and consistent with its template. A "REFER" result is printed if the ALGO 3 cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template. A builten with sufficient statistical volinesive or self-adhesive label, which can be affixed directly to the infant's medical chart.

The ALGO 3 is also capable of screening using clicks at 40 dB nHL. Some newborn hearing The 2000 5 is also capable of the (international programs, for example), and some programs profer to belocit ar to we the screening threshold at 40 dB nHL rather than at 35. The incorporation of a 40 dB screening application in the ALGO 3 device makes the device more useful to more users.

The ALGO 3 device is easy enough for trained volunteers and other trained non-medical personnel to use. Interpretation of screening results is not required, as the screener automatically determines if the response is consist with a template and automatically generates a "PASS" or "REFER" result, as previously discussed. In addition, training is minimal because of the easy-to-navigate graphical user interface, HELP topics in software, and a user tutorial in the ALGO 3 software.

The ALGO 3 is composed of the following components, as is the Predicate Device:

Screening module, with laptop computer �
. Printer module, with label printer
Cable assemblies (ATA, PCA, Preamp) .
Cart for transport and component storage .
Screening and accessory supplies 방

Accessories available for use with the ALGO 3 include single-use, disposable FlexiCouplers Disposable Earphones, and single-use, disposable Jelly Tab Sensors.

E. Intended Use:

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should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.

The screener is simple to operate. It does not require special technical skills or interpretation The solconer is smiple to openate. Annoment is sufficient to learn how to screen infants who of results. Dasie anning out to be discharged from the hospital. A typical screening process are in good neard and about to oc also. Sites appropriate for screening include the wellbaby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Comparison with the Predicate Device: F.

The ALGO 3 Newborn Hearing Screener is a hardware, software, supplies, and materials The ALGO 3 NOW Dom Hearing Screener (K936039). The ALGO 3 and the modition of and Hearing Screeners have the same intended use and use the same operating principle.

Based on the data and information presented here, the modified ALGO 3 Newborn Hearing Screener and Accessories are substantially equivalent to the ALGO-2 Newborn Hearing Screener and Accessories manufactured and distributed by Natus Medical, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling a person with outstretched arms, which is the department's official symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2001

Ms. Sheila Ramerman Director, Regulatory Affairs Natus Medical, Inc. 1501 Industrial Road San Carlos, California 94070-4111

Re: K013137

Trade Name: ALGO® 3 Newborn Hearing Screener Regulation Number: 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: September 18, 2001 Received: September 19, 2001

Dear Ms. Ramerman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 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); 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 - Ms. Sheila Ramerman

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, MP

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

Enclosure

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510(k) Number (if known):

Device Name: _ ALGO® 3 Newborn Hearing Screener and Accessories

Indications for Use:

The screener is simple to operate. It does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good health and about to be discharged from the hospital. A typical screening process can be completed in 15 minutes or less. Sites appropriate for screening include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-The-Counter
(Per 21 CFR 801.109)	Use	(Optional Format 1-2-96)
	(Division Sign-Off)
	Division of General, Restorative and Neurological Devices

510(k) Number	K013137
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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).