The ALGO 5 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 (gestation 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

The ALGO 5 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 5 generates soft clicks at 35 dB nHL or at 40 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).

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 ALGO 5 uses advanced signal processing technology to separate the ABR from background noise and from other brain activity.

The ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR).

AI/ML Overview

The provided text is a 510(k) summary for the Natus Medical ALGO 5 Newborn Hearing Screener, which is a modification of a predicate device (ALGO 3). The submission specifically states that no clinical performance data is included and that the substantial equivalence is based on non-clinical performance data (design verification and validation) showing the ALGO 5 performs equivalently to the ALGO 3.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance for a clinical study cannot be extracted from this document. The document explicitly states "No clinical performance data are included."

However, I can provide the limited information available regarding the comparison with the predicate device and the type of performance data used for substantial equivalence.

Here's what can be inferred from the provided text about the device's performance given the context of a 510(k) submission for a device modification:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical performance data is included, there's no specific table of clinical acceptance criteria or reported clinical device performance in this document. The equivalence is based on non-clinical data.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable, as no clinical test set data is provided.
Data Provenance: Not applicable, as no clinical test set data is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set and thus no ground truth established by experts is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set is discussed.

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 document states "No clinical performance data are included." Also, this device is an automated hearing screener that does not involve human readers interpreting results in the way an MRMC study typically assesses. It uses an "automated auditory brainstem response technology (AABR)".

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

The device is an automated screener, meaning its operation is essentially "standalone" in its assessment. However, the document doesn't present a standalone study as typically requested for AI/ML devices. Instead, it relies on demonstrating equivalence to the predicate device through non-clinical means. The "ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR)." This implies standalone algorithmic performance is inherent to its function, but a specific standalone performance study report is not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable, as no clinical performance data or ground truth for a clinical study is discussed. The device's algorithm uses a "template of ABRs derived from normal hearing infants," which serves as an internal reference for its automated determination.

8. The sample size for the training set:

Not applicable. The document does not describe a new training set. The ALGO 5 is a modification of the ALGO 3 and relies on "advanced signal processing technology to separate the ABR from background noise and from other brain activity" and a "statistical algorithm." The "template of ABRs derived from normal hearing infants" likely refers to data used in the development of the original algorithm (ALGO 3) or the modification, but specific training set details are not provided in this 510(k) summary.

9. How the ground truth for the training set was established:

Not applicable. As no training set details are provided, the method for establishing its ground truth is also not mentioned. The document only references a "template of ABRs derived from normal hearing infants."

Summary

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Special 510(k): Device Modification Natus Medical ALGO 5 Newborn Hearing Screener

510(k) Summary

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

The assigned 510(k) number is:

K073665

A. Submitter

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

Contact

Tom Boles (650) 801-7262

Date Summary Prepared

January 15, 2008

B. Device Names

Classification Name Common/Usual Name Proprietary Name

Stimulator, Auditory Evoked Response Hearing Screener ALGO® 5 Newborn Hearing Screener

C. Predicate Device:

ALGO® 3 Newborn Hearing Screener (K013137)

D. Device Description

E. Intended Use

The screener is simple to operate. It does not require special technical skills or interprefation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good heath and about to be discharged from the hospital. A typical screening process can be

Page A-002

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Special 510(k): Device Modification Natus Medical ALGO 5 Newbom Hearing Screener

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.

Contraindications for Use:

Screening infants with known neurologic conditions should be done only under well-informed medical and/or audiological supervision.

F. Comparison with Predicate Device

The ALGO 5 is a hardware and software modification of the ALGO 3 Newborn Hearing Screener. The ALGO 5 and the ALGO 3 have the same intended use and use the same operating principle.

Based on the data and information presented here, the ALGO 5 Newborn Hearing Screener is substantially equivalent to the ALGO 3 Newborn Hearing Screener currently manufactured and distributed by Natus Medical, Inc.

G. Non-clinical Performance Data

Summaries of design verification and validation are included to demonstrate that the ALGO 5 performs equivalently to the ALGO 3.

H. Clinical Performance Data

No clinical performance data are included.

Page A-003

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

JAN 25 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Natus Medical, Incorporated % Mr. Tom Boles QA Manager 1501 Industrial Road San Carlos, California 94070

Re: K073665

Trade/Device Name: ALGO 5 Newborn Hearing Screener Regulation Number: 21 CFR 882. 1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: Class II Product Code: GWJ Dated: December 20, 2007 Received: December 26, 2007

Dear Mr. Boles:

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 - Mr. Tom Boles

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark N. Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Special 510(k): Device Modification Natus Medical ALGO 5 Newborn Hearing Screener

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K073665

Device Name: ALGO 5 Newborn Hearing Screener

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 heath 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 wellbaby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

Michelle A. Millhiser

(Division Sign-Oil) (Division Sign-On)
Division of General, Restorative, Division of Gercal Devices

510(k) Number_

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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).