The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested.

Device Description

The CHARTR® EP with ASSR CHARTR® OAE Systems Product is substantially equivalent to the CHARTR® EP and CHARTR OAE Systems which has a cleared 510(k): K002985.

The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

ASSR (Auditory Steady-State Response) testing is based on the longestablished principle that stimuli presented at fast rates evoke brain responses that overlap (so-called "steady-state" responses). The overlap results in a stable sinusoidal pattern in the patient's electroencephalogram (EEG). The pattern is detectable with computer algorithms, and is stable only in the EEG of patients whose auditory system responds to the stimulus.

With auditory stimuli, amplitude- and/or frequency-modulation of a sine wave (pure tone) results in a stimulus that is both relatively frequencyspecific and capable of evoking a detectable steady-state response. Research studies have demonstrated that when several such stimuli are presented to a patient simultaneously, the response to each stimulus can be extracted from the (composite) EEG, and the results are comparable to those obtained when the stimuli are presented sequentially. This technique enables assessment of hearing at several frequencies at once.

Responses are detected through analysis of digital samples of the patient's EEG. The analysis consists of two stages: estimation and statistical detection. Estimation involves calculations performed on the EEG samples to produce periodic values for amplitude and/or phase of each response sought. Estimates for each response are passed to a statistical algorithm that calculates the confidence, in percent, that the estimates are consistent with a stable response to the corresponding stimulus. The software declares a response to be present when the confidence reaches a predetermined threshold (i.e. 95%). If the confidence does not reach this threshold within a predetermined amount of time (i.e. 5 minutes of testing), the software declares that no response could be found.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ICS Medical CHARTR® EP with ASSR and CHARTR® OAE Systems:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results. As such, some of the requested information (e.g., precise sample sizes for test/training, number and qualifications of experts for ground truth, adjudication methods, MRMC study details, specific effect sizes, and detailed ground truth establishment for training) is not explicitly present in this type of document. The responses below are based only on the information available in the provided text.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative performance metric format (e.g., minimum sensitivity or specificity). Instead, substantial equivalence is claimed based on the new device (CHARTR® EP with ASSR) operating on the same scientific principle, having comparable clinical purpose, patient population, and electrical/EMI safety standards as the predicate device (CHARTR® EP).

The key difference highlighted is in the interpretation method:

Predicate (CHARTR® EP): Audiologist subjectively identifies responses.
New Device (CHARTR® EP with ASSR): Algorithm objectively identifies responses.

The "reported device performance" related to this algorithmic identification is described as follows:

Feature	Acceptance Criteria (Implied / Predicate Baseline)	Reported Device Performance (CHARTR® EP with ASSR)
Response Detection	Subjective identification by audiologist (standard of care for predicate)	Algorithm objectively identifies responses. Calculations performed on EEG samples provide periodic values for amplitude/phase of each response. A statistical algorithm calculates confidence. Response declared "present" when confidence reaches a predetermined threshold (i.e., 95%). "No response" declared if confidence not reached within a predetermined amount of time (i.e., 5 minutes).
Scientific Principle	Established principle of auditory evoked potentials.	Based on the same long-established principle; stimuli presented at fast rates evoke overlapping ("steady-state") brain responses, resulting in a stable sinusoidal EEG pattern. Detectable with computer algorithms, stable only if auditory system responds.
Clinical Purpose	Aid in detecting hearing loss and lesions in the auditory pathway.	Same.
Patient Population	Adults, children, and infants.	Same.
Electrical Safety	Designed to comply with EN 60601-1 (UL2601)	Same.
EMI Compatibility	Designed to comply with EN 60601-1-2	Same.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The 510(k) summary does not provide any specific sample size for a test set, nor does it detail the provenance of any data used for validation. The document describes the scientific principle of ASSR and mentions "Research studies have demonstrated..." but does not reference a specific study conducted for this 510(k) submission with participant numbers or data origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided in the 510(k) summary. The summary describes the algorithm's objective detection based on a statistical confidence threshold, rather than comparison against a traditional expert-adjudicated ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. The device uses an algorithmic, statistical detection method (95% confidence threshold) rather than external expert adjudication for its output.
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:
- No MRMC comparative effectiveness study is mentioned or summarized. The document highlights that the new device's algorithm replaces subjective interpretation by an audiologist with objective identification, rather than assisting a human reader.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Interpretation" section explicitly states that the CHARTR® EP with ASSR uses an "Algorithm objectively identifies responses." This suggests a standalone performance where the algorithm provides the final determination. The scientific principle details how the algorithm extracts responses and calculates confidence to make a "present" or "no response" declaration independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state a specific ground truth used for validation of the ASSR algorithm in the context of this 510(k). The basis for "substantial equivalence" relies on the established scientific principle and comparison to the predicate, which relies on a human audiologist's subjective identification. The algorithm itself creates its own "decision" based on a statistical confidence threshold (95%), rather than being validated directly against an external, independent ground truth method in this summary. It mentions "Research studies have demonstrated" the comparability of these techniques, implying prior validation in the scientific literature.
The sample size for the training set:
- This information is not provided. The document focuses on the operational principle of the algorithm rather than its development or training data.
How the ground truth for the training set was established:
- This information is not provided.

Summary

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231986

JUL 2 4 2003

510(k) SUMMARY

Submitted by:	ICS MEDICAL125 Commerce DriveSchaumburg, IL 60173-5329
Telephone:	(847)-534-2150
Fax:	(847)-534-2151
Contact Person:	Delmar F. Bloem, President
Date Summary Prepared:	June 26, 2003
Trade Name of Device:	ICS Medical CHARTR® EP withASSR and CHARTR® OAESystems
Common Name:	Auditory Evoked PotentialSystem and OtoacousticEmissions Analyzer System.
Classification Name:	Auditory Evoked PotentialSystem and Audiometer
Substantial Equivalence:	The CHARTR® EP with ASSRCHARTR® OAE SystemsProduct is substantiallyequivalent to the CHARTR® EPand CHARTR OAE Systemswhich has a cleared 510(k):K002985.

Intended Use:

The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

Scientific Principle:

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Electrical Safety:

Both Systems are designed to meet EN 60601-1 standard for Medical devices.

EMI Compatibility:

Both Systems are designed to meet EN 60601-1-2 standard.

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	CHARTR EP	CHARTR EP with ASSR
Stimulus	Click or tone burst	Modulated continuous pure tone
Transducers	Insert, bone	Insert, bone, speaker
Intensity	0-90 db HL	0-120 dB HL
Electrode montage	Low forehead, highforehead and both ears	Low forehead, high forehead andone ear
Patient state	Sleeping or restingquietly	Same
Interpretation	Audiologist subjectivelyidentifies responses	Algorithm objectively identifiesresponses
Clinical purpose	Indicated for auditoryevoked potential testingas an aid in detectinghearing loss and lesionsin the auditory pathway	Same
Patient population	Adults, children, andinfants.	Same
Hardwareconfiguration	Audio board	Audio board with daughter board toprovide multiple AM/FM modulatedtones
Operating system	Win98	Same
Software - protocolwith ASSR	No	Yes
Electrical Safety	Designed to comply withEN 60601-1 (UL2601)	Same
EMI Compatibility	Designed to comply withEN 60601-1-2	Same
Computer System	MCU-90 (IBMcompatible tower) andPortable (TFT activematrix screen) computer	Same
Labeling	Identical for both units	Same
Operator Manual	Covers CHARTR EPversion 2.0	Contains updates for EP versions3.0 and 4.0

Comparison Table for

CHARTR® EP vs. CHARTR® EP with ASSR

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines above two wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

ICS Medical c/o Delmar F. Bloem, President 125 Commerce Drive Schaumburg, IL 60173-5329

Re: K031986

Trade/Device Name: ICS MEDICAL CHARTR® EP WITH ASSR AND CHARTR® OAE SYSTEMS

Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: June 26, 2003 Received: June 27, 2003

Dear Mr. Bloem:

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 - Delmar F. Bloem, President

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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. halyi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of_1

510(k) Number (if known):_Ko 3 1986

Device Name: ICS Medical CHARTR® EP with ASSR and CHARTR® OAE Systems Indications For Use:

The CHARTR® EP System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Orms K. Kan, Ph D
Division Sign-Off

Division of Ophthalmic Ear,
Nose and Throat Devices

510(k) Number K031582

(Optional Format 3-10-98)

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.