(49 days)
The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
SmartTrOAE is an otoacoustic emissions testing device that is capable of measuring transient and spontaneous otoacoustic emissions produced by the inner ear.
This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive study protocol and results for the SmartTrOAE device independently.
However, I can extract the available information regarding acceptance criteria and device performance based on similarity to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in terms of specific thresholds for performance metrics. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the SmartTrOAE to the predicate device, ILO88 (K890124). The implicit acceptance criterion is that the SmartTrOAE's performance in these listed parameters is similar enough to the predicate to be considered substantially equivalent.
| Parameter | Acceptance Criteria (Predicate Device ILO88 - K890124) | Reported Device Performance (SmartTrOAE) |
|---|---|---|
| Stimulus Type | Click | Click or Tone |
| Stimulus Duration | 100 µsec | 25 - 5000 µsec |
| Stimulus Intensity | 90 dB SPL | 60 - 90 dB SPL |
| Repetition Rate | 50 Hz | 1 - 50 Hz |
| Microphone | Otodynamics | Etymotic Research ER 10B (K930553) or Etymotic Research ER 10D (K011114) |
| Measured Values | Stimulus Level (dB SPL), Response Level (dB SPL), Noise Level (dB SPL), Signal to Noise Ratio (dB SPL) | Stimulus Level (dB SPL), Response Level (dB SPL), Noise Level (dB SPL), Signal to Noise Ratio (dB SPL) |
| Bandlimit Filter | 500 - 5000 Hz | 500 - 5000 Hz |
| Analysis Window | 2.5 to 20 msec post stimulus | 2.5 - 22.5 msec post stimulus |
| Freq. Spectrum | 0 - 6000 Hz | 0 - 6000 Hz |
| Sweeps | 1 - 260 | 1 - 260 |
| Rejection Threshold | User Selectable | User Selectable |
2. Sample size used for the test set and the data provenance:
This document does not report on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The substantial equivalence is based on comparing technical specifications and intended use with a predicate device. There is no mention of a clinical study with a test set for the SmartTrOAE's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document does not report on any ground truth establishment by experts for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This document does not report on an adjudication method for a test set.
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:
This document does not report on an MRMC comparative effectiveness study. The SmartTrOAE is an otoacoustic emissions testing device, which typically provides objective measurements (otoacoustic emissions) and does not involve "human readers" in the interpretation of complex images or data that an AI might assist with.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This document does not explicitly detail a standalone performance study. The device itself is an "otoacoustic emissions testing device," implying it takes objective measurements. The intended use "without requiring a subjective response from the person being tested" suggests a standalone measurement capability. However, detailed performance metrics from such a study are not provided. The comparison is solely based on technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This document does not describe a type of ground truth used as it does not present a formal clinical study for the SmartTrOAE. The basis for equivalence is the similarity in technical characteristics and intended use to a legally marketed predicate device.
8. The sample size for the training set:
This document does not report on a training set sample size. This type of device (otoacoustic emissions) typically uses established physiological principles and signal processing, rather than machine learning models that require a "training set" in the conventional sense of AI/ML devices.
9. How the ground truth for the training set was established:
This document does not report on the establishment of ground truth for a training set.
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Image /page/0/Picture/1 description: The image shows the logo for Intelligent Hearing Systems. The words "Intelligent Hearing" are in large, bold, black letters. Below that, the word "Systems" is spelled out with each letter in a black square with white text.
JAN 0 8 2003
510(k) Summary
| Prepared By: | Intelligent Hearing Systems7356 SW 48th StreetMiami, FL 33155 | |
|---|---|---|
| Telephone: | (305) 668-6102 | |
| FAX: | (305) 668-6103 | |
| Contact Person: | Edward Miskiel | |
| Date Summary prepared: | December 17, 2002 | |
| Name of the Device: | SmartTrOAE | |
| Common Name: | Otoacoustic Emissions Test Instrument | |
| Classification Name: | Audiometer (per CFR 874.1050) | |
| Predicate Device: | Otodynamics ILO88 (K962995) | |
| Device Description: | SmartTrOAE is an otoacoustic emissions testing device that iscapable of measuring transient and spontaneous otoacousticemissions produced by the inner ear. | |
| Intended Use: | The intended use of the SmartTrOAE device is to measureotoacoustic emissions, which allow the operator to getinformation on cochlear function without requiring a subjectiveresponse from the person being tested with the device. It isintended to be used by trained personnel in a hospital, nursery,clinic, audiologist's office or other appropriate setting. | |
| Technological Characteristics: | The SmartTrOAE device is similar to the predicate device in itsintended use and methodologies.The SmartTrOAE device technologically differs from thepredicate device in that the electronic circuitry of SmartTrOAEdevice is housed in an external box that is connected to personalcomputer by a USB cable connection, whereas the electroniccircuitry of the predicate device is housed internally to thecomputer and is connected to the computer by an interface bus. |
INTELLIGENT HEARING SYSTEMS
7356 S.W. 48th Street
• Miami, Florida 33155 • • Telephone: 305-668-6102 • FAX: 305-668-6103
Email Address: info@ihsys.com • www.ihsys.com Email Address: info@ihsys.com • www.ihsys.com
K: 305-668-6103
Page E1
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Substantial Equivalence Based on Assessment of Performance Data:
The SmartTrOAE is substantially equivalent to the ILO88 device marketed by Otodynamics Ltd. with FDA 510(k) clearance number K890124.
| Parameter | Predicate Device(Non-Preamendmant Device)ILO88(K890124) | Device Under Current 510(k)ReviewSmartTrOAE | |
|---|---|---|---|
| Stimulus | |||
| Type | Click | Click or Tone | |
| Duration | 100 µsec | 25 - 5000 µsec | |
| Intensity | 90 dB SPL | 60 - 90 dB SPL | |
| Repetition Rate | 50 Hz | 1 - 50 Hz | |
| Microphone | Otodynamics | Etymotic Research ER 10B(K930553) orEtymotic Research ER 10D(K011114) | |
| Measured Values | Stimulus Level (dB SPL)Response Level (dB SPL)Noise Level (dB SPL)Signal to Noise Ratio (dB SPL) | Stimulus Level (dB SPL)Response Level (dB SPL)Noise Level (dB SPL)Signal to Noise Ratio (dB SPL) | |
| MeasurementParameters | Bandlimit FilterAnalysis WindowFreq. Spectrum | 500 - 5000 Hz2.5 to 20 msec post stimulus0 - 6000 Hz | 500 - 5000 Hz2.5 - 22.5 msec post stimulus0 - 6000 Hz |
| Analysis Parameters | SweepsRejection Threshold | 1 - 260User Selectable | 1 - 260User Selectable |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2003
Intelligent Hearing Systems c/o Edward Miskiel, Ph.D. 7356 SW 48th Street Miami, FL 33155
Re: K023859
Trade/Device Name: Otoacoustic Emissions Test Instrument / SmarTrOAE Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: November 19, 2002 Received: November 20, 2002
Dear Dr. Miskiel:
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
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Page 2 - Edward Miskiel, Ph.D.
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. 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) you may obtain. 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,
J. Joseph 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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510(k) Number (if known): K023859
Device Name: SmartTrOAE
Indications For Use:
The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
The anatomical site of contact is the patient's outer ear canal(s) with the contact object being a probe that is capable of measuring and delivering sound.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation
Jams K. Kane, Ph.D.
Division Sign-Off
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K023859
§ 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.